Trial CTRI/2020/05/025209
Publication Ray Y, Nat Commun, 2022 (published paper)
Dates: 2020-05-31 to 2020-10-12
Funding: Public/non profit (Council of Scientific Industrial Research (CSIR), Govt. of India and Fondation Botnar)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / India Follow-up duration (days): 30 | |
Inclusion criteria | Consenting patients admitted with RT-PCR proven COVID-19 with severe disease (fever or suspected respiratory infection, plus one of the following: respiratory rate >30 breaths/min, severe respiratory distress, SpO2< 90% at room air) with mild ARDS, defined as patients having partial pressure of oxygen in the arterial blood (PaO2)/fraction of inspired oxygen (FiO2) ratio of 200-300 mmHg or moderate ARDS, defined as PaO2/FiO2 100-200 mmHg, not on mechanical ventilation |
Exclusion criteria | Pregnant or breastfeeding mothers; Patients with age less than 18 years; Patients participating in any other clinical trial; Patients having any clinical condition precluding infusion of blood products |
Interventions | |
Treatment
Convalescent plasma 200 mL IV once a day on two consecutive days. |
|
Control
Standard care Definition of Standard care: At the clinical trial site (ID & BG Hospital, Kolkata, India) standard-of-care (SOC) in all patients with evidence for ARDS were: O2 therapy as per requirement, either intravenous or oral corticosteroids, for patients with D-dimer <1000 Fibrinogen Equivalent Units (FEU) prophylactic anticoagulation and for patients with D-dimer >1000 ng/ml FEU therapeutic anticoagulation using either low molecular weight heparin or unfractionated heparin, appropriate broadspectrum antibiotic therapy based on clinical, biochemical and microbiological assessment, appropriate anti-diabetic therapy to maintain blood sugar below 200 mg/dl, anti-hypertensive agents, as per requirement, were used to maintain systolic blood pressure 100-140mm of Hg, diastolic blood pressure at 70–90mm of Hg and mean arterial pressure >65mm of Hg. Other therapy included azithromycin, remdesevir, tocilizumab, and hydroxychloroquine. | |
Participants | |
Randomized 80 participants (n1=40 / n2= 40) | |
Characteristics of participants N=80 Mean age : NR 57 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=80 Critical: n=0 | |
Primary outcome | |
In the register To compare ‘all cause’ mortality. To identify the immune correlates for response to plasma therapy. Timepoints: Discharge. Discharge/death. Day 0, Day 3, Day 7 after admission. | |
In the report All-cause mortality on day 30 after enrolment and identification of immunological correlates of response to CPT, if any. | |
Documents available |
Protocol Yes. In English Statistical plan NR Data-sharing stated Yes |
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
High |
General comment |
In addition to the published article, the preprint, the protocol and the trial registry was used in data extraction and assessment of risk of bias. The statistical analysis plan was not available. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome (all cause mortality) timepoint does not reflect the timepoint reported in the published report.
This study was updated on March 2nd, 2022 with data extracted from the published report. |