Trial CTRI/2020/04/024775
Publication Agarwal A, medRxiv, 2020
Dates: 2020-04-22 to 2020-07-14
Funding: Public/non profit ( ICMR, an autonomous Government-funded medical research council)
| Methods | |
| RCT | |
| Location :
Multicenter / India Follow-up duration (days): 28 | |
| Inclusion criteria | Patients aged at least 18 years who were confirmed to have COVID-19 based on a positive SARSCoV-2 RT-PCR test and were admitted to the participating hospitals were screened for eligibility and included if they were moderately ill with either partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio between 200-300 or respiratory rate >24/min with SpO2 < 93% on room air, and if matched donor CP was available at the point of enrolment. |
| Exclusion criteria | Pregnant and lactating women, patients with known hypersensitivity to blood products, recipients of immunoglobulin in the last 30 days, patients with conditions precluding infusion of blood products, participants in any other clinical trials and critically ill patients with PaO2/ FiO2 < 200 or shock (requiring vasopressors to maintain a mean arterial pressure (MAP) >= 65 or MAP < 65) were considered ineligible to participate. |
| 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 practised by the participating clinical sites for the management of COVID-19 patients included: antivirals (Hydroxychloroquine, Remdesivir, Lopinavir/Ritonavir, Oseltamivir), broad spectrum antibiotics, immunomodulators (steroids, Tocilizumab) and supportive management (oxygen via nasal cannula, face mask, non-rebreathing face mask; non-invasive 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 primary outcome of the study was a 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 | These are personal comments that will not save on the personal comment page, Overall comment at end of text box- Recovery outcomes not extracted (as advised).- Clinical improvement based on WHO criteria was added post-hoc, however, they do not provide the results in this paper. For this reason, I did not consider this as an outcome.- negative conversion n's seem to be reversed between day 3 and 7 in table 2, based on calculation's using the %s. I've calculated the n's for each group at each time point based on the n (%).- AEs were only reported for the CP group, so this outcome was not extracted.Overall commentIn addition to all available versions of the pre-print article, the study registry was used in data extraction and risk of bias assessment. There was no protocol available but outcomes were reported as described in the study registry. |