Effects of Home-Based Respiratory Physiotherapy and Telephone- Based Psychological Support on Pulmonary and Mental Health Outcomes in Peru: A Feasibility Randomized Controlled Trial

Introduction: We sought to determine whether a 6-week integrated rehabilitation program improved pulmonary function, physical and mental health outcomes in patients discharged alive after surviving a severe COVID-19 pneumonia. Methods: Parallel, open-label, feasibility randomized controlled trial in participants aged 18-75 years who were discharged for severe COVID-19 pneumonia. The intervention consisted of 12 in-person home respiratory rehabilitation sessions and 6 telephonebased, emotion-centered problem-solving therapy psychological sessions. We measured the 6- minute walk test (6MWT), forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), Patient Health Questionnaire (PHQ-9), General Anxiety Disorder (GAD-7), Impact of Event Scale- Revised (IES-R) and Short Form 36 health survey (SF-36). Following the recommendation by Cocks and Torgerson, we used a one-sided 80% confidence interval to determine if this feasibility trial should proceed to a phase III trial. Results: We randomized 103 participants (mean age, 48 years;71% men). There were no differences at baseline assessments of outcomes between the two groups. Intervention participants walked 15 and 45 meters more during a 6MWT at 7 and 12 weeks, respectively, than controls after accounting for baseline distance. In both instances, the onesided 80% lower bound was above 0. Intervention participants also had a greater improvement of lung function for week 7 (mean difference FEV1, 0.05 L;95% CI, -0.14 to 0.24;mean difference FVC, 0.10 L;95% CI, -0.12 to 0.31) and at week 12 (mean difference FEV1, 0.10 L;95% CI, -0.18 to 0.37;mean difference FVC, 0.15 L;95% CI, -0.17 to 0.47). Likewise, the prevalence of depression (percentage difference PHQ-9, 24.3%;95% CI, -4.3 to 44.3), anxiety (percentage difference GAD-7, 20.7%;95% CI, 0.8 to 40.6) and post-traumatic stress (percentage difference IES-R, 14.0%;95% CI, -5.7 to 33.7) were lower in the intervention group at week 2 after hospital discharge. At week 7, the intervention group had a greater improvement of physical (mean difference, 10.8;95% CI, -1.8 to 23.4) and social (mean difference, 6.43;95% CI, -0.65 to 13.5) function on the SF-36. Conclusion: We demonstrated that an integrated rehabilitation program administered over a 6-week after discharge in Lima, Peru was both feasible and acceptable, and had positive benefits on physical and pulmonary function and on mental health during the 12 weeks of follow-up. Measured improvements in the primary outcome of 6MWT distance recommend that we consider a phase III trial to test the efficacy of our integrated rehabilitation intervention in a larger sample.

Cock tail for COVID 19 disease - Experience from a teritiary hospital in South India

Background: REGEN-COV is a combination of 2 monoclonal antibodies (casirivimab and imdevimab) that bind to two different sites on the receptor binding domain of the SARS-CoV-2 spike protein, and thus stops the progression of disease. We aim to evaluate the safety and efficacy of REGEN COV in patients presenting with Mild to moderate Covid 19 disease. Methodology: This is a retrospective observational study done in a tertiary hospital in South India. Patients admitted with RTPCR confirmed SARS COV 2 infection and within 10 days of symptoms onset were included in the trial. All patients received 1,200 mg each of casirivimab and imdevimab as a single intravenous infusion. All the patients were followed up for a period of 30 days with weekly telephonic consultation. Results: Between June 1 , 2021 and October 15 ,2021 , 30 patients got enrolled into the study and the mean age of patients was 60 years. The median duration from symptom onset to Regen Cov treatment was 5 days. Only 2 (10%) patients had adverse events and 83% of patients (25/30) had no symptoms after Regen Cov administration and 86% of patients (26/30) had no progression of clinical symptoms for up to 30 days after discharge. Conclusion: The monoclonal antibody combination of casirivimab and imdevimab (REGEN-COV) successfully prevented the progression of disease in 86% of patients presented with mild to moderate COVID 19 disease. Our study also underlined the safety of Regen Cov treatment with no major adverse event occurred in any of the patients.