To Assess the Safety and Efficacy of Convalescent Plasma on outcome of COVID-19 Associated Complications

World Health Organization declared the novel corona virus disease(COVID-19), to be a pandemic on 11th  March 2020 [1].  COVID-19 is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Fever, cough, fatigue, sore throat, shortness of breath are common symptoms and nasal discharge, headache, nausea and diarrhea are less common symptoms of COVID- 19. The most common abnormalities in vital signs is increased temperature and tachypnea. Bilateral pulmonary infiltrates, ground glass opacities and consolidation are the common radiological abnormalities seen in these patients. The severe disease occurs in those who are elderly, diabetic, hypertensive, D- dimer levels raised, higher SOFA score, elevated IL-6, increased Lactate Dehydrogenase, hyperferritinemia and lymphopenia on admission[6,7]. The most common complications are sepsis, respiratory failure, acute respiratory distress syndrome (ARDS), cardiac involvement and acute kidney injury. The pathophysiological mechanisms responsible for this disease are not fully understood but many theories have been hypothesized for bad prognosis in COVID-19. At present, there are no approved treatments for COVID-19. The management plan is largely supportive with  symptomatics ,supplemental oxygen and noninvasive respiratory  support (Noninvasive ventilation, HFNC) and invasive mechanical ventilation. Various trials are being done across the globe to assess the efficacy of various treatment. US FDA has recently approved Convalescent Plasma from patients recovered from COVID-19 for the treatment of severe or life threatening COVID-19 infections. Five critically ill COVID-19 patients in a small case series with ARDS were treated with convalescent plasma containing neutralizing antibodies. Infusion of plasma resulted in improvement in clinical status with no deaths and the study reported that three patients were discharged,whilst two continued to be stable on mechanical ventilation. We hypothesize that use of convalescent plasma will limit the progression of disease in Hospitalized COVID-19 patients with Severe or Life threatening disease. Therefore, we hereby plan to conduct a multicentric randomized controlled trial to test the hypothesis. RT-PCR confirmed Covid-19 postive patients > 18 years old, having severe or life threatening disease shall be enrolled in the study. After obtaining informed consent, patients will randomized either of two treatment groups (Intervention or control group). Intervention group will receive 2 doses of 200 ml each of convalescent plasma along standard of care treatment while control group will receive standard of care treatment alone. The primary outcome is a composite measure of the avoidance of all cause mortality at 28 days and worsening of SOFA score post transfusion.