Trial NCT04530370
Publication Salman OH, Egypt J Anaesth, 2020 (published paper)
Dates: 2020-05-29 to 2020-08-30
Funding: Not reported/unclear
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Single center / Egypt Follow-up duration (days): 5 | |
| Inclusion criteria | Hospitalized patients ≥18 years ; confirmed positive nasopharyngeal/oropharyngeal covid-19 swab ; have two or more of - Respiratory frequency ≥24/min, Blood oxygen saturation ≤ 93% on room air, Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300 mmHg, Pulmonary infiltrates occupying more than 50% of both lungs. |
| Exclusion criteria | Prior allergic history to plasma or plasma products ; septic shock ; multiple organ failure. |
| Interventions | |
| Treatment
Convalescent plasma 250 ml intravenously once-off |
|
| Control
Standard care ( / ) Definition of Standard care: Available standard therapy, when appropriate, included: supplemental oxygen, noninvasive and invasive ventilation, antibiotic medication, inotrope drugs, renal-replacement therapy, anti-coagulants, glucocorticoids, intravenous fluids, interferon, and extracorporeal membrane oxygenation (ECMO). | |
| Participants | |
| Randomized 30 participants (n1=15 / n2= 15) | |
| Characteristics of participants N=30 Mean age : NR 21 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=30 Critical: n=0 | |
| Primary outcome | |
| In the register Satisfactory outcome [ Time Frame: 5 days ] Patients' response to recovered Covid 19 plasma (RCP) during 5 days after transfusion, was our primary goal. It was categorized into either satisfactory or unsatisfactory outcomes. We defined satisfactory outcome as two or more of the following 4 conditions/ or otherwise unsatisfactory: 1. respiratory frequency < 30/min, 2. Sustain blood oxygen saturation ≥93% on room air, 3. partial pressure of arterial oxygen to fraction of inspired oxygen ratio > 300 mmHg, 4. Regression of pulmonary infiltrates occupying less than 50% of both lungs. | |
| In the report At least 50% improvement of the severity of illness at any time during 5 days study period after transfusion, was our primary end point. 50% Improvement of severity of illness was defined as achieving a minimum of two-point reduction on the four-category illness-severity scale: Respiratory frequency ≥ 24/min; blood oxygen saturation ≤ 93% on room air; partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300 mmHg; pulmonary infiltrates occupying more than 50% of both lungs, during 5 days study period. | |
| 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 trial registration was used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. Differences in inclusion criteria, blinding description, randomisation and reported outcomes between (retrospectively registered) trial registration and published paper. Reported as 2:1 randomization, yet group sizes were equal. The primary outcome stated in both the registry and the published paper was not reported. Instead the four clinical domains, improvement in two of which was the primary outcome, are reported separately. None of the secondary outcomes reported were included in the retrospective trial registration. |