Trial IRCT20200310046736N1
Publication Pouladzadeh M, Intern Emerg Med, 2021 (published paper)
Dates: 2020-03-01 to 2020-05-30
Funding: Public/non profit (Ahvaz University of Medical Sciences)
Conflict of interest: *
| Methods | |
| RCT Blinding: single blinding | |
| Location :
Single center / Iran Follow-up duration (days): 60 | |
| Inclusion criteria | COVID-19 patients who had specified COVID-19 symptoms (less than 7 days since the onset of the symptoms) ; positive results of PCR test and CT scan ; Severity WHO score > 4 ; Blood oxygen saturation (SPO2) ≤ 93% in room air ; no exhibit hypersensitivity to plasma intravenous administration ; informed consent. |
| Exclusion criteria | NR |
| Interventions | |
| Treatment
Convalescent plasma 500 ml IV infusion on admission day (in the first 4 hours); optional 500 ml by IV infusion after 24 hours if no improvement. |
|
| Control
Standard care ( / ) Definition of Standard care: All patients received similar antiviral therapy, including Ritonavir/Lopinavir, and chloroquine phosphate. | |
| Participants | |
| Randomized 62 participants (n1=31 / n2= 31) | |
| Characteristics of participants N=62 Mean age : 55.4 33 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=45 Critical: n=15 | |
| Primary outcome | |
| In the register Complete remission of clinical signs of disease (7 days), negative result for COVID-19 RT-PCR test and normal scan (14 days). | |
| In the report Improvement in the levels of cytokine storm indices | |
| Documents available |
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 |
Some concerns |
| General comment | In addition to the published article, the retrospective trial registry was used in data extraction and assessment of the risk of bias. The study achieved the estimated sample size. There may be some changes from the trial registration in the intervention treatment. Of note, the trial was described as single-blind in the report; however, participants, investigators, outcome assessor, data analyzer would be masked according to the registry. The registry primary outcome does not reflect the reported primary outcome. None of the primary outcomes in the registry are reported in the article (complete remission, negative RT-PCR, normal CT scan), while several outcomes not in the registry are reported (length of hospitalization WHO 8-point ordinal scale severities, adjusted analyses of laboratory outcomes and survival). |