COVID-19

Key clinical point: Johnson & Johnson's (J&J) adenoviral vector COVID-19 vaccine (Ad26.COV) was effective in preventing COVID-19 and severe outcomes in a real-world setting.

Major finding: The incidence rate ratio of COVID-19 in the Ad26.COV-vaccinated vs unvaccinated cohort was 0.26 (95% CI, 0.20-0.34), corresponding to an effectiveness of 73.6% (95% CI, 65.9%-79.9%). Ad26.COV recipients also had a lower risk for hospitalization (odds ratio [OR], 0.32; P = .00028) and ICU admissions (OR, 0.00; P = .001) compared with unvaccinated individuals.

Study details: The data come from an analysis of 8,889 individuals vaccinated with Ad26.COV and 88,898 unvaccinated matched controls.

Disclosures: No information on funding was available. J Corchado-Garcia, D Zemmour, T Hughes, P Lenehan, C Pawlowski, JC O’Horo, AD Badley, MD Swift, T Wagner, and V Soundararajan reported relationships with various pharmaceutical companies. The remaining authors declared no conflict of interests.

Source: Corchado-Garcia J et al. JAMA Netw Open. 2021 Nov 2. doi: 10.1001/jamanetworkopen.2021.32540.

Key clinical point: Johnson & Johnson's (J&J) adenoviral vector COVID-19 vaccine (Ad26.COV) was effective in preventing COVID-19 and severe outcomes in a real-world setting.

Major finding: The incidence rate ratio of COVID-19 in the Ad26.COV-vaccinated vs unvaccinated cohort was 0.26 (95% CI, 0.20-0.34), corresponding to an effectiveness of 73.6% (95% CI, 65.9%-79.9%). Ad26.COV recipients also had a lower risk for hospitalization (odds ratio [OR], 0.32; P = .00028) and ICU admissions (OR, 0.00; P = .001) compared with unvaccinated individuals.

Study details: The data come from an analysis of 8,889 individuals vaccinated with Ad26.COV and 88,898 unvaccinated matched controls.

Disclosures: No information on funding was available. J Corchado-Garcia, D Zemmour, T Hughes, P Lenehan, C Pawlowski, JC O’Horo, AD Badley, MD Swift, T Wagner, and V Soundararajan reported relationships with various pharmaceutical companies. The remaining authors declared no conflict of interests.

Source: Corchado-Garcia J et al. JAMA Netw Open. 2021 Nov 2. doi: 10.1001/jamanetworkopen.2021.32540.

Key clinical point: Johnson & Johnson's (J&J) adenoviral vector COVID-19 vaccine (Ad26.COV) was effective in preventing COVID-19 and severe outcomes in a real-world setting.

Major finding: The incidence rate ratio of COVID-19 in the Ad26.COV-vaccinated vs unvaccinated cohort was 0.26 (95% CI, 0.20-0.34), corresponding to an effectiveness of 73.6% (95% CI, 65.9%-79.9%). Ad26.COV recipients also had a lower risk for hospitalization (odds ratio [OR], 0.32; P = .00028) and ICU admissions (OR, 0.00; P = .001) compared with unvaccinated individuals.

Study details: The data come from an analysis of 8,889 individuals vaccinated with Ad26.COV and 88,898 unvaccinated matched controls.

Disclosures: No information on funding was available. J Corchado-Garcia, D Zemmour, T Hughes, P Lenehan, C Pawlowski, JC O’Horo, AD Badley, MD Swift, T Wagner, and V Soundararajan reported relationships with various pharmaceutical companies. The remaining authors declared no conflict of interests.

Source: Corchado-Garcia J et al. JAMA Netw Open. 2021 Nov 2. doi: 10.1001/jamanetworkopen.2021.32540.

Key clinical point: A single subcutaneous dose of levilimab (LVL) was safe and effective in severely ill patients with COVID-19 not requiring mechanical ventilation.

Major finding: 63.1% of patients in the LVL group vs 42.7% in the placebo group achieved sustained clinical improvement on day 14 (P = .0017). Adverse event frequency was comparable between the groups.

Study details: In the phase 3 CORONA trial, 206 patients were randomly assigned (1:1) to receive either LVL+standard of care (SOC) vs placebo+SOC.

Disclosures: This study was funded by JSC BIOCAD. MY Gilyarov reported ties with various pharmaceutical companies. AI Seleznev, YN Linkova, EA Dokukina, PS Pukhtinskaia, AV Eremeeva, MA Morozova, AV Zinkina-Orikhan, and AA Lutckii are employees of JSC BIOCAD.

Source: Lomakin NV et al. Inflamm Res. 2021 Sep 29. doi: 10.1007/s00011-021-01507-5.

Key clinical point: A single subcutaneous dose of levilimab (LVL) was safe and effective in severely ill patients with COVID-19 not requiring mechanical ventilation.

Major finding: 63.1% of patients in the LVL group vs 42.7% in the placebo group achieved sustained clinical improvement on day 14 (P = .0017). Adverse event frequency was comparable between the groups.

Study details: In the phase 3 CORONA trial, 206 patients were randomly assigned (1:1) to receive either LVL+standard of care (SOC) vs placebo+SOC.

Disclosures: This study was funded by JSC BIOCAD. MY Gilyarov reported ties with various pharmaceutical companies. AI Seleznev, YN Linkova, EA Dokukina, PS Pukhtinskaia, AV Eremeeva, MA Morozova, AV Zinkina-Orikhan, and AA Lutckii are employees of JSC BIOCAD.

Source: Lomakin NV et al. Inflamm Res. 2021 Sep 29. doi: 10.1007/s00011-021-01507-5.

Key clinical point: A single subcutaneous dose of levilimab (LVL) was safe and effective in severely ill patients with COVID-19 not requiring mechanical ventilation.

Major finding: 63.1% of patients in the LVL group vs 42.7% in the placebo group achieved sustained clinical improvement on day 14 (P = .0017). Adverse event frequency was comparable between the groups.

Study details: In the phase 3 CORONA trial, 206 patients were randomly assigned (1:1) to receive either LVL+standard of care (SOC) vs placebo+SOC.

Disclosures: This study was funded by JSC BIOCAD. MY Gilyarov reported ties with various pharmaceutical companies. AI Seleznev, YN Linkova, EA Dokukina, PS Pukhtinskaia, AV Eremeeva, MA Morozova, AV Zinkina-Orikhan, and AA Lutckii are employees of JSC BIOCAD.

Source: Lomakin NV et al. Inflamm Res. 2021 Sep 29. doi: 10.1007/s00011-021-01507-5.

Key clinical point: HIV-positive individuals are more likely to be hospitalized for or die from COVID-19 compared with non-HIV individuals.

Major finding: The HIV-positive vs non-HIV group had a higher risk for COVID-19-related hospitalization (adjusted odds ratio [aOR], 1.20; 95% CI, 1.15-1.26) and mortality (aOR, 1.29; 95% CI, 1.16-1.44). The risk was pronounced for older patients, male sex, and Black race.

Study details: The data come from a US population-based surveillance study involving 1,436,622 COVID-19 cases, of which 13,170 were HIV positive.

Disclosures: The study was funded by National Center for Advancing Translational Sciences, National Institute of Allergy and Infectious Diseases, and National Institutes of Health, USA. The authors declared no competing interests.

Source: Yang X et al. Lancet HIV. 2021 Oct 13. doi: 10.1016/S2352-3018(21)00239-3.

Key clinical point: HIV-positive individuals are more likely to be hospitalized for or die from COVID-19 compared with non-HIV individuals.

Major finding: The HIV-positive vs non-HIV group had a higher risk for COVID-19-related hospitalization (adjusted odds ratio [aOR], 1.20; 95% CI, 1.15-1.26) and mortality (aOR, 1.29; 95% CI, 1.16-1.44). The risk was pronounced for older patients, male sex, and Black race.

Study details: The data come from a US population-based surveillance study involving 1,436,622 COVID-19 cases, of which 13,170 were HIV positive.

Disclosures: The study was funded by National Center for Advancing Translational Sciences, National Institute of Allergy and Infectious Diseases, and National Institutes of Health, USA. The authors declared no competing interests.

Source: Yang X et al. Lancet HIV. 2021 Oct 13. doi: 10.1016/S2352-3018(21)00239-3.

Key clinical point: HIV-positive individuals are more likely to be hospitalized for or die from COVID-19 compared with non-HIV individuals.

Major finding: The HIV-positive vs non-HIV group had a higher risk for COVID-19-related hospitalization (adjusted odds ratio [aOR], 1.20; 95% CI, 1.15-1.26) and mortality (aOR, 1.29; 95% CI, 1.16-1.44). The risk was pronounced for older patients, male sex, and Black race.

Study details: The data come from a US population-based surveillance study involving 1,436,622 COVID-19 cases, of which 13,170 were HIV positive.

Disclosures: The study was funded by National Center for Advancing Translational Sciences, National Institute of Allergy and Infectious Diseases, and National Institutes of Health, USA. The authors declared no competing interests.

Source: Yang X et al. Lancet HIV. 2021 Oct 13. doi: 10.1016/S2352-3018(21)00239-3.

Key clinical point: Heart rate variability (HRV) is a predictor of survival and intensive care unit (ICU) admission in older adults hospitalized with COVID-19.

Major finding: After adjusting for age and chronic heart disease, HRV was a significant predictor of survival (adjusted hazard ratio [aHR] with low vs high HRV, 0.51; 95% CI, 0.27-0.97). This association was primarily driven by patients aged ≥70 years (aHR with low vs high HRV, 0.28; 95% CI, 0.12-0.66). HRV also predicted ICU admission within the first week of hospitalization (adjusted HR, 0.51; 95% CI, 0.29-0.90), independent of age and chronic heart disease.

Study details: The data come from a retrospective cohort study involving 271 consecutive adults hospitalized with COVID-19 between March 2020 and May 2020.

Disclosures: The study did not receive any specific funding. The authors declared no competing interests.

Source: Mol MBA et al. PLoS One. 2021 Oct 28. doi: 10.1371/journal.pone.0258841.

Key clinical point: Heart rate variability (HRV) is a predictor of survival and intensive care unit (ICU) admission in older adults hospitalized with COVID-19.

Major finding: After adjusting for age and chronic heart disease, HRV was a significant predictor of survival (adjusted hazard ratio [aHR] with low vs high HRV, 0.51; 95% CI, 0.27-0.97). This association was primarily driven by patients aged ≥70 years (aHR with low vs high HRV, 0.28; 95% CI, 0.12-0.66). HRV also predicted ICU admission within the first week of hospitalization (adjusted HR, 0.51; 95% CI, 0.29-0.90), independent of age and chronic heart disease.

Study details: The data come from a retrospective cohort study involving 271 consecutive adults hospitalized with COVID-19 between March 2020 and May 2020.

Disclosures: The study did not receive any specific funding. The authors declared no competing interests.

Source: Mol MBA et al. PLoS One. 2021 Oct 28. doi: 10.1371/journal.pone.0258841.

Key clinical point: Heart rate variability (HRV) is a predictor of survival and intensive care unit (ICU) admission in older adults hospitalized with COVID-19.

Major finding: After adjusting for age and chronic heart disease, HRV was a significant predictor of survival (adjusted hazard ratio [aHR] with low vs high HRV, 0.51; 95% CI, 0.27-0.97). This association was primarily driven by patients aged ≥70 years (aHR with low vs high HRV, 0.28; 95% CI, 0.12-0.66). HRV also predicted ICU admission within the first week of hospitalization (adjusted HR, 0.51; 95% CI, 0.29-0.90), independent of age and chronic heart disease.

Study details: The data come from a retrospective cohort study involving 271 consecutive adults hospitalized with COVID-19 between March 2020 and May 2020.

Disclosures: The study did not receive any specific funding. The authors declared no competing interests.

Source: Mol MBA et al. PLoS One. 2021 Oct 28. doi: 10.1371/journal.pone.0258841.

Key clinical point: Sotrovimab significantly reduced the risk for complications, hospitalization, or mortality in patients with mild-to-moderate COVID-19.

Major finding: 1% of patients in the sotrovimab group vs 7% in the placebo group experienced disease progression leading to hospitalization (relative risk reduction, 85%; P = .002). Grade 3/4 adverse events were reported in 2% of patients in the sotrovimab group vs 6% of patients in the placebo group.

Study details: The data come from a prespecified, interim analysis of the ongoing, double-blind, placebo-controlled phase 3 COMET-ICE trial assessing the efficacy and safety of sotrovimab in patients with high-risk, ambulatory, mild-to-moderate COVID-19.

Disclosures: The COMET-ICE trial was funded by Vir Biotechnology and GlaxoSmithKline. The COMET-ICE Investigators reported relationships with Vir Biotechnology and GlaxoSmithKline.

Source: Gupta A et al. N Engl J Med. 2021 Oct 27. doi: 10.1056/NEJMoa2107934.

Key clinical point: Sotrovimab significantly reduced the risk for complications, hospitalization, or mortality in patients with mild-to-moderate COVID-19.

Major finding: 1% of patients in the sotrovimab group vs 7% in the placebo group experienced disease progression leading to hospitalization (relative risk reduction, 85%; P = .002). Grade 3/4 adverse events were reported in 2% of patients in the sotrovimab group vs 6% of patients in the placebo group.

Study details: The data come from a prespecified, interim analysis of the ongoing, double-blind, placebo-controlled phase 3 COMET-ICE trial assessing the efficacy and safety of sotrovimab in patients with high-risk, ambulatory, mild-to-moderate COVID-19.

Disclosures: The COMET-ICE trial was funded by Vir Biotechnology and GlaxoSmithKline. The COMET-ICE Investigators reported relationships with Vir Biotechnology and GlaxoSmithKline.

Source: Gupta A et al. N Engl J Med. 2021 Oct 27. doi: 10.1056/NEJMoa2107934.

Key clinical point: Sotrovimab significantly reduced the risk for complications, hospitalization, or mortality in patients with mild-to-moderate COVID-19.

Major finding: 1% of patients in the sotrovimab group vs 7% in the placebo group experienced disease progression leading to hospitalization (relative risk reduction, 85%; P = .002). Grade 3/4 adverse events were reported in 2% of patients in the sotrovimab group vs 6% of patients in the placebo group.

Study details: The data come from a prespecified, interim analysis of the ongoing, double-blind, placebo-controlled phase 3 COMET-ICE trial assessing the efficacy and safety of sotrovimab in patients with high-risk, ambulatory, mild-to-moderate COVID-19.

Disclosures: The COMET-ICE trial was funded by Vir Biotechnology and GlaxoSmithKline. The COMET-ICE Investigators reported relationships with Vir Biotechnology and GlaxoSmithKline.

Source: Gupta A et al. N Engl J Med. 2021 Oct 27. doi: 10.1056/NEJMoa2107934.

Key clinical point: Individuals who had received diphtheria or tetanus vaccinations in the last 10 years were less likely to develop severe COVID-19 compared with those who had not received them.

Major finding: The study included 103,049 participants (mean age, 71.5 years; 54.2% women) with vaccination records for the past 10 years and data on COVID-19 testing.

Study details: Individuals who had been vaccinated against diphtheria (odds ratio [OR], 0.47; 95% CI, 0.33-0.68; P = .000053) and tetanus (OR, 0.52; 95% CI, 0.37-0.72; P = .00012) in the last 10 years had a lower likelihood of developing severe COVID-19 symptoms compared with those who had not received them.

Disclosures: The study was funded by the Research Council of Norway, the South-Eastern Norway Regional Health Authority, Stiftelsen Kristian Gerhard Jebsen, The European Research Council under the European Union’s Horizon 2020 research and innovation programme, and National Institutes of Health. O Andreassen and J Pinzón-Espinosa reported relationships with various pharmaceutical companies. The remaining authors declared no conflict of interests.

Source: Monereo-Sánchez J et al. Front Immunol. 2021 Oct 7. doi: 10.3389/fimmu.2021.749264.

Key clinical point: Individuals who had received diphtheria or tetanus vaccinations in the last 10 years were less likely to develop severe COVID-19 compared with those who had not received them.

Major finding: The study included 103,049 participants (mean age, 71.5 years; 54.2% women) with vaccination records for the past 10 years and data on COVID-19 testing.

Study details: Individuals who had been vaccinated against diphtheria (odds ratio [OR], 0.47; 95% CI, 0.33-0.68; P = .000053) and tetanus (OR, 0.52; 95% CI, 0.37-0.72; P = .00012) in the last 10 years had a lower likelihood of developing severe COVID-19 symptoms compared with those who had not received them.

Disclosures: The study was funded by the Research Council of Norway, the South-Eastern Norway Regional Health Authority, Stiftelsen Kristian Gerhard Jebsen, The European Research Council under the European Union’s Horizon 2020 research and innovation programme, and National Institutes of Health. O Andreassen and J Pinzón-Espinosa reported relationships with various pharmaceutical companies. The remaining authors declared no conflict of interests.

Source: Monereo-Sánchez J et al. Front Immunol. 2021 Oct 7. doi: 10.3389/fimmu.2021.749264.

Key clinical point: Individuals who had received diphtheria or tetanus vaccinations in the last 10 years were less likely to develop severe COVID-19 compared with those who had not received them.

Major finding: The study included 103,049 participants (mean age, 71.5 years; 54.2% women) with vaccination records for the past 10 years and data on COVID-19 testing.

Study details: Individuals who had been vaccinated against diphtheria (odds ratio [OR], 0.47; 95% CI, 0.33-0.68; P = .000053) and tetanus (OR, 0.52; 95% CI, 0.37-0.72; P = .00012) in the last 10 years had a lower likelihood of developing severe COVID-19 symptoms compared with those who had not received them.

Disclosures: The study was funded by the Research Council of Norway, the South-Eastern Norway Regional Health Authority, Stiftelsen Kristian Gerhard Jebsen, The European Research Council under the European Union’s Horizon 2020 research and innovation programme, and National Institutes of Health. O Andreassen and J Pinzón-Espinosa reported relationships with various pharmaceutical companies. The remaining authors declared no conflict of interests.

Source: Monereo-Sánchez J et al. Front Immunol. 2021 Oct 7. doi: 10.3389/fimmu.2021.749264.

Key clinical point: Addition of colchicine to standard of care (SOC) had no significant benefit in hospitalized COVID-19 patients.

Major finding: There were no significant differences between SOC alone and SOC plus colchicine groups in all-cause mortality (rate ratio [RR], 1.01; P = .77), probability of being discharged alive within 28 days (RR, 0.98; P = .44), and the risk of progressing to invasive mechanical ventilation or death (RR, 1.02; P = .47).

Study details: In the RECOVERY trial, 11,340 hospitalized COVID-19 patients were randomly assigned to receive SOC with (n=5,610) or without (n=5,730) colchicine.

Disclosures: The RECOVERY trial was funded by the UK Research and Innovation (Medical Research Council), National Institute for Health Research, and Wellcome Trust. The authors declared no competing interests.

Source: RECOVERY Collaborative Group. Lancet Respir Med. 2021 Oct 18. doi: 10.1016/ S2213-2600(21)00435-5.

Key clinical point: Addition of colchicine to standard of care (SOC) had no significant benefit in hospitalized COVID-19 patients.

Major finding: There were no significant differences between SOC alone and SOC plus colchicine groups in all-cause mortality (rate ratio [RR], 1.01; P = .77), probability of being discharged alive within 28 days (RR, 0.98; P = .44), and the risk of progressing to invasive mechanical ventilation or death (RR, 1.02; P = .47).

Study details: In the RECOVERY trial, 11,340 hospitalized COVID-19 patients were randomly assigned to receive SOC with (n=5,610) or without (n=5,730) colchicine.

Disclosures: The RECOVERY trial was funded by the UK Research and Innovation (Medical Research Council), National Institute for Health Research, and Wellcome Trust. The authors declared no competing interests.

Source: RECOVERY Collaborative Group. Lancet Respir Med. 2021 Oct 18. doi: 10.1016/ S2213-2600(21)00435-5.

Key clinical point: Addition of colchicine to standard of care (SOC) had no significant benefit in hospitalized COVID-19 patients.

Major finding: There were no significant differences between SOC alone and SOC plus colchicine groups in all-cause mortality (rate ratio [RR], 1.01; P = .77), probability of being discharged alive within 28 days (RR, 0.98; P = .44), and the risk of progressing to invasive mechanical ventilation or death (RR, 1.02; P = .47).

Study details: In the RECOVERY trial, 11,340 hospitalized COVID-19 patients were randomly assigned to receive SOC with (n=5,610) or without (n=5,730) colchicine.

Disclosures: The RECOVERY trial was funded by the UK Research and Innovation (Medical Research Council), National Institute for Health Research, and Wellcome Trust. The authors declared no competing interests.

Source: RECOVERY Collaborative Group. Lancet Respir Med. 2021 Oct 18. doi: 10.1016/ S2213-2600(21)00435-5.

Key clinical point: In patients with nonvalvular atrial fibrillation (AF), warfarin use was linked to a lower risk of SARS-CoV-2 infection and adverse COVID-19 outcomes compared with the use of direct oral anticoagulants (DOACs).

Major finding: Warfarin vs DOAC use was associated with a lower risk for testing positive for SARS-CoV-2 (adjusted hazard ratio [aHR]; 0.73; 95% CI, 0.68-0.79), COVID-19-related hospitalization (aHR, 0.75; 95% CI, 0.68-0.83), and COVID-19-related mortality (aHR, 0.74; 95% CI, 0.66-0.83).

Study details: The details come from a population-based cohort study involving 92,339 warfarin users and 280,407 DOAC users. The OpenSAFELY platform was used for data analysis.

Disclosures: The OpenSAFELY data science platform was funded by the Wellcome Trust. OpenSAFELY work was jointly funded by UKRI, NIHR, Asthma UK-BLF, and the Longitudinal Health and Wellbeing strand of the National Core Studies programme. Principal investigator B Goldacre reported relationships with various research organizations. The co-principal investigator IJ Douglas reported ties with GSK.

Source: OpenSAFELY Collaborative et al. J Hematol Oncol. 2021 Oct 19. doi: 10.1186/s13045-021-01185-0.

Key clinical point: In patients with nonvalvular atrial fibrillation (AF), warfarin use was linked to a lower risk of SARS-CoV-2 infection and adverse COVID-19 outcomes compared with the use of direct oral anticoagulants (DOACs).

Major finding: Warfarin vs DOAC use was associated with a lower risk for testing positive for SARS-CoV-2 (adjusted hazard ratio [aHR]; 0.73; 95% CI, 0.68-0.79), COVID-19-related hospitalization (aHR, 0.75; 95% CI, 0.68-0.83), and COVID-19-related mortality (aHR, 0.74; 95% CI, 0.66-0.83).

Study details: The details come from a population-based cohort study involving 92,339 warfarin users and 280,407 DOAC users. The OpenSAFELY platform was used for data analysis.

Disclosures: The OpenSAFELY data science platform was funded by the Wellcome Trust. OpenSAFELY work was jointly funded by UKRI, NIHR, Asthma UK-BLF, and the Longitudinal Health and Wellbeing strand of the National Core Studies programme. Principal investigator B Goldacre reported relationships with various research organizations. The co-principal investigator IJ Douglas reported ties with GSK.

Source: OpenSAFELY Collaborative et al. J Hematol Oncol. 2021 Oct 19. doi: 10.1186/s13045-021-01185-0.

Key clinical point: In patients with nonvalvular atrial fibrillation (AF), warfarin use was linked to a lower risk of SARS-CoV-2 infection and adverse COVID-19 outcomes compared with the use of direct oral anticoagulants (DOACs).

Major finding: Warfarin vs DOAC use was associated with a lower risk for testing positive for SARS-CoV-2 (adjusted hazard ratio [aHR]; 0.73; 95% CI, 0.68-0.79), COVID-19-related hospitalization (aHR, 0.75; 95% CI, 0.68-0.83), and COVID-19-related mortality (aHR, 0.74; 95% CI, 0.66-0.83).

Study details: The details come from a population-based cohort study involving 92,339 warfarin users and 280,407 DOAC users. The OpenSAFELY platform was used for data analysis.

Disclosures: The OpenSAFELY data science platform was funded by the Wellcome Trust. OpenSAFELY work was jointly funded by UKRI, NIHR, Asthma UK-BLF, and the Longitudinal Health and Wellbeing strand of the National Core Studies programme. Principal investigator B Goldacre reported relationships with various research organizations. The co-principal investigator IJ Douglas reported ties with GSK.

Source: OpenSAFELY Collaborative et al. J Hematol Oncol. 2021 Oct 19. doi: 10.1186/s13045-021-01185-0.

Key clinical point: There is an increased risk of neurological complications following COVID-19 vaccination; however, this risk is substantially higher following SARS-CoV-2 infection.

Major finding: There was an increased risk for Guillain-Barré syndrome and Bell’s palsy following vaccination with ChAdOx1nCoV-19 (incidence rate ratio [IRR], 2.90 [95% CI, 2.15-3.92] and 1.29 [95% CI, 1.08-1.56], respectively) and for hemorrhagic stroke following vaccination with BNT162b2 (IRR, 1.38; 95% CI, 1.12-1.71). The risk for all neurological complications was significantly higher within 28 days of a positive SARS-CoV-2 test, including Guillain-Barré syndrome (IRR, 5.25; 95% CI, 3.00-9.18).

Study details: The data come from an analysis of 20,417,752 individuals who received ChAdOx1nCoV-19 (AstraZeneca) COVID-19 vaccine, 12,134,782 who received BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine, and 2,005,280 who tested positive for COVID-19.

Disclosures: No specific funding information was available. A Sheikh, D Hunt, K Khunti, C Robertson, and J Hippisley-Cox reported ties with various research organizations and/or advisory groups. The remaining authors declared no conflict of interests.

Source: Patone M et al. Nat Med. 2021 Oct 25. doi: 10.1038/s41591-021-01556-7.

Key clinical point: There is an increased risk of neurological complications following COVID-19 vaccination; however, this risk is substantially higher following SARS-CoV-2 infection.

Major finding: There was an increased risk for Guillain-Barré syndrome and Bell’s palsy following vaccination with ChAdOx1nCoV-19 (incidence rate ratio [IRR], 2.90 [95% CI, 2.15-3.92] and 1.29 [95% CI, 1.08-1.56], respectively) and for hemorrhagic stroke following vaccination with BNT162b2 (IRR, 1.38; 95% CI, 1.12-1.71). The risk for all neurological complications was significantly higher within 28 days of a positive SARS-CoV-2 test, including Guillain-Barré syndrome (IRR, 5.25; 95% CI, 3.00-9.18).

Study details: The data come from an analysis of 20,417,752 individuals who received ChAdOx1nCoV-19 (AstraZeneca) COVID-19 vaccine, 12,134,782 who received BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine, and 2,005,280 who tested positive for COVID-19.

Disclosures: No specific funding information was available. A Sheikh, D Hunt, K Khunti, C Robertson, and J Hippisley-Cox reported ties with various research organizations and/or advisory groups. The remaining authors declared no conflict of interests.

Source: Patone M et al. Nat Med. 2021 Oct 25. doi: 10.1038/s41591-021-01556-7.

Key clinical point: There is an increased risk of neurological complications following COVID-19 vaccination; however, this risk is substantially higher following SARS-CoV-2 infection.

Major finding: There was an increased risk for Guillain-Barré syndrome and Bell’s palsy following vaccination with ChAdOx1nCoV-19 (incidence rate ratio [IRR], 2.90 [95% CI, 2.15-3.92] and 1.29 [95% CI, 1.08-1.56], respectively) and for hemorrhagic stroke following vaccination with BNT162b2 (IRR, 1.38; 95% CI, 1.12-1.71). The risk for all neurological complications was significantly higher within 28 days of a positive SARS-CoV-2 test, including Guillain-Barré syndrome (IRR, 5.25; 95% CI, 3.00-9.18).

Study details: The data come from an analysis of 20,417,752 individuals who received ChAdOx1nCoV-19 (AstraZeneca) COVID-19 vaccine, 12,134,782 who received BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine, and 2,005,280 who tested positive for COVID-19.

Disclosures: No specific funding information was available. A Sheikh, D Hunt, K Khunti, C Robertson, and J Hippisley-Cox reported ties with various research organizations and/or advisory groups. The remaining authors declared no conflict of interests.

Source: Patone M et al. Nat Med. 2021 Oct 25. doi: 10.1038/s41591-021-01556-7.

Telehealth is safe and effective for the treatment of borderline personality disorder (BPD) and may even have an edge over in-person treatment, new research suggests.

Courtesy Dr. Mark Zimmerman

Investigators compared BPD outcomes with therapy delivered in person and via telemedicine and found comparable reductions in depression, anxiety, and anger symptoms as well as improved overall well-being and mental health.

The results also suggest a telehealth advantage with significantly better patient attendance vs. patients treated in-person.

“We found a large effect size of treatment in both groups, as well as comparable levels of satisfaction with treatment, symptom reduction, and improved functioning, coping ability, positive mental health, and general well-being,” study investigator Mark Zimmerman, MD, professor of psychiatry and human behavior, Brown University, Providence, R.I., said in an interview.

The study was published online Nov. 8 in the Journal of Personality Disorders.
 

‘No other option’

Most previous research investigating telehealth has occurred in outpatient, individual treatment settings and has not examined telehealth-delivered group therapy or partial hospitalization, the authors noted.

“Until the pandemic, we were delivering care in person, but when the pandemic began, because of public safety recommendations, we knew that we could no longer continue doing so,” said Dr. Zimmerman, director of the outpatient division at the partial hospital program (PHP), Rhode Island Hospital.

“In switching to a telehealth platform, we were concerned about patient safety and acceptability of delivering care in that manner, especially with patients with BPD, which is associated with impulsive behavior, self-harm, and suicidal behavior, among other problems,” he said. However “we had no other option” than to utilize a telehealth delivery mode, since the alternative was to shut down the program.

The investigators were “interested in whether or not virtual treatment in an acute intensive setting, such as a PHP, would be as safe, acceptable, and effective as in-person treatment.”

The study was part of the ongoing work of the Rhode Island Methods to Improve Diagnostic Assessment and Services.
 

Additional safety measures

Treatment, consisting of an Acceptance and Commitment Therapy (ACT) treatment model – including intake assessments, individual therapy, psychiatric visits, and group therapy – was delivered by a multidisciplinary team via Zoom.

Dr. Zimmerman noted that the team implemented additional safety precautions, including having patients check in at the beginning of each day to indicate their location, not seeing patients who were out of state, and making sure all patients had a contact person.

In addition, beyond the therapist leading the group, another therapist was always available, overseeing groups and meeting one-on-one (virtually) with participants if they had been triggered by the group process and were highly distressed.

Patients were asked to complete a number of questionnaires, including the Clinically Useful Patient Satisfaction Scale (CUPSS) at the end of their intake session. The primary outcome measure was the Remission from Depression Questionnaire (RDQ-M).

The study was conducted between May 1 and Dec. 15 of 2020 and included 64 patients with BPD who were treated for the first time in the Rhode Island Hospital PHP. They were compared to 117 patients who participated in the in-person program during the same months in 2019.

Participant characteristics were similar – for example, three-quarters of the participants in both groups were female, and the mean age was 34 years.
 

‘Sea change’

Most patients in the telehealth and in-person groups reported being “very” or “extremely” satisfied with the initial evaluation (90% vs. 85.3%, c² = 0.74) and were hopeful that they would get better (85.8% vs. 82.1%, c² = 0.45).

Upon completion of the program, 100% of the in-person and 95.4% of the telehealth group indicated that they were “very” or “extremely” satisfied (c² = 4.62), and “under both telehealth and in-person treatment conditions, the patients significantly improved from admission to discharge on each of the RDQ-M subscales, with large effect sizes found for most of the subscales,” the authors reported.

There were significant differences between the groups in the average number of days of attendance and number of days missed.

A nonsignificantly higher proportion of patients completed the telehealth program, vs. the in-person program (68.8% vs. 59%, c² = 1.69).

In both programs, transfer to inpatient care and dissatisfaction-related withdrawal from the program were low (both < 2%). Notably, no patients attempted or completed suicide during treatment.

Virtual treatment is more convenient than in-person treatment, Dr. Zimmerman noted. “Some patients – generally those with medical or transportation issues – told us they otherwise would not have been able to participate [in the program] if treatment had been in person.”

He added, “My prediction is that 5 years from now, two-thirds to three-quarters of outpatient visits will be virtual because that is what the patients prefer – and although there will certainly be individuals who prefer in-person care, I think we’ve witnessed a sea change in how behavioral health care will be delivered.”
 

‘Game changer’

In an interview, Monica Carsky, PhD, clinical assistant professor of psychology in psychiatry and a senior fellow at the Personality Disorders Institute, Weill Cornell Medical College, New York, said the study has “a lot of valuable detail about how to set up a virtual PHP, which could guide any group wanting to try this.”

Dr. Carsky, who was not involved with the study, called it “a very important contribution to the research literature on efficacious treatment of BPD,” although it is not a randomized controlled trial.

“Adding more individual attention to the virtual group (e.g., having a co-host in the groups) seems as though it may be an important factor in dealing with the limitations of virtual treatment,” she noted.

However, she continued, “a limitation is that outcome assessment relied on self-administered questionnaires and did not include clinician rating scales, so the response may have been subject to the effects of social desirability bias.”

Courtesy Dr. Donald Black

Donald W. Black, MD, associate chief of staff for mental health at the Iowa City Veterans Administration Hospital, said in an interview that the pandemic has been a “game changer, as we have had to quickly adapt mental health programs to a virtual format.

“For the most part, they have been remarkably successful for a variety of conditions, and Zimmerman and colleagues now show this for BPD families,” said Dr. Black, who was not associated with the research.

No study funding was listed. The study authors, Dr. Carsky, and Dr. Black have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Telehealth is safe and effective for the treatment of borderline personality disorder (BPD) and may even have an edge over in-person treatment, new research suggests.

Courtesy Dr. Mark Zimmerman

Investigators compared BPD outcomes with therapy delivered in person and via telemedicine and found comparable reductions in depression, anxiety, and anger symptoms as well as improved overall well-being and mental health.

The results also suggest a telehealth advantage with significantly better patient attendance vs. patients treated in-person.

“We found a large effect size of treatment in both groups, as well as comparable levels of satisfaction with treatment, symptom reduction, and improved functioning, coping ability, positive mental health, and general well-being,” study investigator Mark Zimmerman, MD, professor of psychiatry and human behavior, Brown University, Providence, R.I., said in an interview.

The study was published online Nov. 8 in the Journal of Personality Disorders.
 

‘No other option’

Most previous research investigating telehealth has occurred in outpatient, individual treatment settings and has not examined telehealth-delivered group therapy or partial hospitalization, the authors noted.

“Until the pandemic, we were delivering care in person, but when the pandemic began, because of public safety recommendations, we knew that we could no longer continue doing so,” said Dr. Zimmerman, director of the outpatient division at the partial hospital program (PHP), Rhode Island Hospital.

“In switching to a telehealth platform, we were concerned about patient safety and acceptability of delivering care in that manner, especially with patients with BPD, which is associated with impulsive behavior, self-harm, and suicidal behavior, among other problems,” he said. However “we had no other option” than to utilize a telehealth delivery mode, since the alternative was to shut down the program.

The investigators were “interested in whether or not virtual treatment in an acute intensive setting, such as a PHP, would be as safe, acceptable, and effective as in-person treatment.”

The study was part of the ongoing work of the Rhode Island Methods to Improve Diagnostic Assessment and Services.
 

Additional safety measures

Treatment, consisting of an Acceptance and Commitment Therapy (ACT) treatment model – including intake assessments, individual therapy, psychiatric visits, and group therapy – was delivered by a multidisciplinary team via Zoom.

Dr. Zimmerman noted that the team implemented additional safety precautions, including having patients check in at the beginning of each day to indicate their location, not seeing patients who were out of state, and making sure all patients had a contact person.

In addition, beyond the therapist leading the group, another therapist was always available, overseeing groups and meeting one-on-one (virtually) with participants if they had been triggered by the group process and were highly distressed.

Patients were asked to complete a number of questionnaires, including the Clinically Useful Patient Satisfaction Scale (CUPSS) at the end of their intake session. The primary outcome measure was the Remission from Depression Questionnaire (RDQ-M).

The study was conducted between May 1 and Dec. 15 of 2020 and included 64 patients with BPD who were treated for the first time in the Rhode Island Hospital PHP. They were compared to 117 patients who participated in the in-person program during the same months in 2019.

Participant characteristics were similar – for example, three-quarters of the participants in both groups were female, and the mean age was 34 years.
 

‘Sea change’

Most patients in the telehealth and in-person groups reported being “very” or “extremely” satisfied with the initial evaluation (90% vs. 85.3%, c² = 0.74) and were hopeful that they would get better (85.8% vs. 82.1%, c² = 0.45).

Upon completion of the program, 100% of the in-person and 95.4% of the telehealth group indicated that they were “very” or “extremely” satisfied (c² = 4.62), and “under both telehealth and in-person treatment conditions, the patients significantly improved from admission to discharge on each of the RDQ-M subscales, with large effect sizes found for most of the subscales,” the authors reported.

There were significant differences between the groups in the average number of days of attendance and number of days missed.

A nonsignificantly higher proportion of patients completed the telehealth program, vs. the in-person program (68.8% vs. 59%, c² = 1.69).

In both programs, transfer to inpatient care and dissatisfaction-related withdrawal from the program were low (both < 2%). Notably, no patients attempted or completed suicide during treatment.

Virtual treatment is more convenient than in-person treatment, Dr. Zimmerman noted. “Some patients – generally those with medical or transportation issues – told us they otherwise would not have been able to participate [in the program] if treatment had been in person.”

He added, “My prediction is that 5 years from now, two-thirds to three-quarters of outpatient visits will be virtual because that is what the patients prefer – and although there will certainly be individuals who prefer in-person care, I think we’ve witnessed a sea change in how behavioral health care will be delivered.”
 

‘Game changer’

In an interview, Monica Carsky, PhD, clinical assistant professor of psychology in psychiatry and a senior fellow at the Personality Disorders Institute, Weill Cornell Medical College, New York, said the study has “a lot of valuable detail about how to set up a virtual PHP, which could guide any group wanting to try this.”

Dr. Carsky, who was not involved with the study, called it “a very important contribution to the research literature on efficacious treatment of BPD,” although it is not a randomized controlled trial.

“Adding more individual attention to the virtual group (e.g., having a co-host in the groups) seems as though it may be an important factor in dealing with the limitations of virtual treatment,” she noted.

However, she continued, “a limitation is that outcome assessment relied on self-administered questionnaires and did not include clinician rating scales, so the response may have been subject to the effects of social desirability bias.”

Courtesy Dr. Donald Black

Donald W. Black, MD, associate chief of staff for mental health at the Iowa City Veterans Administration Hospital, said in an interview that the pandemic has been a “game changer, as we have had to quickly adapt mental health programs to a virtual format.

“For the most part, they have been remarkably successful for a variety of conditions, and Zimmerman and colleagues now show this for BPD families,” said Dr. Black, who was not associated with the research.

No study funding was listed. The study authors, Dr. Carsky, and Dr. Black have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Telehealth is safe and effective for the treatment of borderline personality disorder (BPD) and may even have an edge over in-person treatment, new research suggests.

Courtesy Dr. Mark Zimmerman

Investigators compared BPD outcomes with therapy delivered in person and via telemedicine and found comparable reductions in depression, anxiety, and anger symptoms as well as improved overall well-being and mental health.

The results also suggest a telehealth advantage with significantly better patient attendance vs. patients treated in-person.

“We found a large effect size of treatment in both groups, as well as comparable levels of satisfaction with treatment, symptom reduction, and improved functioning, coping ability, positive mental health, and general well-being,” study investigator Mark Zimmerman, MD, professor of psychiatry and human behavior, Brown University, Providence, R.I., said in an interview.

The study was published online Nov. 8 in the Journal of Personality Disorders.
 

‘No other option’

Most previous research investigating telehealth has occurred in outpatient, individual treatment settings and has not examined telehealth-delivered group therapy or partial hospitalization, the authors noted.

“Until the pandemic, we were delivering care in person, but when the pandemic began, because of public safety recommendations, we knew that we could no longer continue doing so,” said Dr. Zimmerman, director of the outpatient division at the partial hospital program (PHP), Rhode Island Hospital.

“In switching to a telehealth platform, we were concerned about patient safety and acceptability of delivering care in that manner, especially with patients with BPD, which is associated with impulsive behavior, self-harm, and suicidal behavior, among other problems,” he said. However “we had no other option” than to utilize a telehealth delivery mode, since the alternative was to shut down the program.

The investigators were “interested in whether or not virtual treatment in an acute intensive setting, such as a PHP, would be as safe, acceptable, and effective as in-person treatment.”

The study was part of the ongoing work of the Rhode Island Methods to Improve Diagnostic Assessment and Services.
 

Additional safety measures

Treatment, consisting of an Acceptance and Commitment Therapy (ACT) treatment model – including intake assessments, individual therapy, psychiatric visits, and group therapy – was delivered by a multidisciplinary team via Zoom.

Dr. Zimmerman noted that the team implemented additional safety precautions, including having patients check in at the beginning of each day to indicate their location, not seeing patients who were out of state, and making sure all patients had a contact person.

In addition, beyond the therapist leading the group, another therapist was always available, overseeing groups and meeting one-on-one (virtually) with participants if they had been triggered by the group process and were highly distressed.

Patients were asked to complete a number of questionnaires, including the Clinically Useful Patient Satisfaction Scale (CUPSS) at the end of their intake session. The primary outcome measure was the Remission from Depression Questionnaire (RDQ-M).

The study was conducted between May 1 and Dec. 15 of 2020 and included 64 patients with BPD who were treated for the first time in the Rhode Island Hospital PHP. They were compared to 117 patients who participated in the in-person program during the same months in 2019.

Participant characteristics were similar – for example, three-quarters of the participants in both groups were female, and the mean age was 34 years.
 

‘Sea change’

Most patients in the telehealth and in-person groups reported being “very” or “extremely” satisfied with the initial evaluation (90% vs. 85.3%, c² = 0.74) and were hopeful that they would get better (85.8% vs. 82.1%, c² = 0.45).

Upon completion of the program, 100% of the in-person and 95.4% of the telehealth group indicated that they were “very” or “extremely” satisfied (c² = 4.62), and “under both telehealth and in-person treatment conditions, the patients significantly improved from admission to discharge on each of the RDQ-M subscales, with large effect sizes found for most of the subscales,” the authors reported.

There were significant differences between the groups in the average number of days of attendance and number of days missed.

A nonsignificantly higher proportion of patients completed the telehealth program, vs. the in-person program (68.8% vs. 59%, c² = 1.69).

In both programs, transfer to inpatient care and dissatisfaction-related withdrawal from the program were low (both < 2%). Notably, no patients attempted or completed suicide during treatment.

Virtual treatment is more convenient than in-person treatment, Dr. Zimmerman noted. “Some patients – generally those with medical or transportation issues – told us they otherwise would not have been able to participate [in the program] if treatment had been in person.”

He added, “My prediction is that 5 years from now, two-thirds to three-quarters of outpatient visits will be virtual because that is what the patients prefer – and although there will certainly be individuals who prefer in-person care, I think we’ve witnessed a sea change in how behavioral health care will be delivered.”
 

‘Game changer’

In an interview, Monica Carsky, PhD, clinical assistant professor of psychology in psychiatry and a senior fellow at the Personality Disorders Institute, Weill Cornell Medical College, New York, said the study has “a lot of valuable detail about how to set up a virtual PHP, which could guide any group wanting to try this.”

Dr. Carsky, who was not involved with the study, called it “a very important contribution to the research literature on efficacious treatment of BPD,” although it is not a randomized controlled trial.

“Adding more individual attention to the virtual group (e.g., having a co-host in the groups) seems as though it may be an important factor in dealing with the limitations of virtual treatment,” she noted.

However, she continued, “a limitation is that outcome assessment relied on self-administered questionnaires and did not include clinician rating scales, so the response may have been subject to the effects of social desirability bias.”

Courtesy Dr. Donald Black

Donald W. Black, MD, associate chief of staff for mental health at the Iowa City Veterans Administration Hospital, said in an interview that the pandemic has been a “game changer, as we have had to quickly adapt mental health programs to a virtual format.

“For the most part, they have been remarkably successful for a variety of conditions, and Zimmerman and colleagues now show this for BPD families,” said Dr. Black, who was not associated with the research.

No study funding was listed. The study authors, Dr. Carsky, and Dr. Black have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.