NCT04346446.

Study name	Efficacy of convalescent plasma therapy in severely sick COVID‐19 patients: a pilot randomized controlled trial
Methods	Trial design: randomised, clinical trial  Sample size: 20 Setting: hospital Country: India Language: English Number of centres: 2
Participants	Inclusion criteria Severe COVID‐19 infections defined as WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID‐19 of National Health Commission of China (version 5.0) with confirmation by RT‐PCR assay with severe disease i.e. meeting any 2 of the following criteria: respiratory distress, respiratory rate ≥ 30 breaths/min oxygen saturation level < 93% in resting state PaO2)/FiO2 ≤ 300 mmHg lung infiltrates > 50% within 24‐48 h Exclusion criteria Donors who gave negative consent to participate in the study Aged < 18 years or > 65 years Known comorbid diseases (cardiopulmonary disease‐structural or valvular heart disease, coronary artery disease, COPD, chronic liver disease, chronic kidney disease) Multi‐organ failure or requiring mechanical ventilation Pregnancy HIV or hepatitis BMI > 35 kg/m2 Extremely moribund patients with an expected life expectancy of < 24 h Failure to give informed consent from the patient or family members Haemodynamic instability requiring vasopressors Previous allergic history to plasma PaO2/FiO2 < 150 Donors who were recovered with use of steroids during treatment
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP  Details of CP: type of plasma: NR, up to 500 mL collected  volume: 200‐600 mL number of doses: NR antibody‐titre: NR pathogen inactivated or not: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR For studies including a control group: comparator (type): randomised 1:1 to CP or random plasma and best supportive care Concomitant therapy: NR Treatment cross‐overs: NR
Outcomes	Primary study outcome: proportion of participants remaining free of mechanical ventilation Primary review outcomes All‐cause mortality at hospital discharge: yes  mortality in both groups (time frame: day 28) Time to death: NR Secondary review outcomes Number of participants with grade 3 and grade 4 AEs, including potential relationship between intervention and adverse reaction (e.g. TRALI, transfusion‐transmitted infection, TACO, TAD, acute transfusion reactions): NR Number of participants with SAEs: NR Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: yes 30‐day and 90‐day mortality: NR Admission on the ICU: NR Length of stay on the ICU: yes Time to discharge from hospital: yes QoL: NR Additional outcomes Improvement in Pa02/Fi02 ratio in both groups (time frame: day 2) Improvement in Pa02/Fi02 ratio in both groups (time frame: day 7) Improvement in SOFA score in both groups (time frame: day 2) Improvement in SOFA score in both groups (time frame: day 7) Requirements of vasopressor in both groups (time frame: day 28) Days free of dialysis in both groups (time frame: day 28)
Starting date	14 April 2020
Contact information	Dr Meenu Bajpai, MD, Institute of Liver and Biliary Sciences, India  mailto:meenubajpai%40hotmail.com?subject=NCT04346446, ILBS‐COVID‐02, Efficacy of Convalescent Plasma Therapy in Severely Sick COVID‐19 Patients
Notes	Recruitment status: completed Prospective completion date: 20 June 2020 Sponsor/funding: Institute of Liver and Biliary Sciences, India