Trial CTRI/2020/04/024775
Publication Agarwal A, BMJ, 2020 (published paper)
Dates: 2020-04-22 to 2020-07-14
Funding: Public/non profit (Indian Council of Medical Research (ICMR))
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / India Follow-up duration (days): 28 | |
| Inclusion criteria | Patients aged at least 18 years who had confirmed covid-19 based on a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for SARSCoV- 2 and had been admitted to the participating hospitals were screened for eligibility. Inclusion criteria were moderate illness with either a partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24/min with oxygen saturation (SpO2) 93% or less on room air,17 and availability of a matched donor for convalescent plasma at the point of enrolment. |
| Exclusion criteria | Pregnant and lactating women, patients with known hypersensitivity to blood products, recipients of immunoglobulin in the past 30 days, patients with conditions precluding infusion of blood products, participants in any other clinical trials, and critically ill patients with PaO2/ FiO2 <200 mm Hg or shock (requiring vasopressors to maintain a mean arterial pressure (MAP) of ≥65 mm Hg or MAP of <65 mm Hg). |
| Interventions | |
| Treatment
Convalescent plasma (200 ml) Co-Intervention: Standard care Duration : 2 days |
|
| Control
Standard care Definition of Standard care: The range of treatment protocols followed by the participating clinical sites for the management of patients with covid-19 included antivirals(hydroxychloroquine, remdesivir, lopinavir/ ritonavir, oseltamivir), broad spectrum antibiotics, immunomodulators (steroids, tocilizumab), and supportive management (oxygen through a nasal cannula, face mask, non-rebreathing face mask; noninvasive or invasive mechanical ventilation; awake proning. | |
| Participants | |
| Randomized 464 participants (n1=235 / n2= 229) | |
| Characteristics of participants N=464 Mean age : NR 354 males Severity : Mild: n=361 / Moderate: n=101/ Severe: n=1 Critical: n=* | |
| Primary outcome | |
| In the register Yes | |
| In the report The composite measure of progress to severe disease (PaO2/FiO2 ratio <100) any time within 28 days of enrolment or all-cause mortality at 28 days. | |
| Documents avalaible |
Protocol NR 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 all available versions of the pre-prints and published article, the study registry was used in data extraction and risk of bias assessment.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 primary outcome indicated in registry reflects the primary outcome reported in the paper
This study was updated on 03/11/2020 based on the published article. |