Trial NCT04356534
Publication AlQahtani M, Sci Rep, 2021 (published paper)
Dates: 2020-04-19 to 2020-06-15
Funding: Public/non profit (Ministry of Health Bahrain and the College of Surgeons in Ireland-Bahrain)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / Bahrain Follow-up duration (days): 28 | |
| Inclusion criteria | (1) signed informed consent;
(2) aged at least 21 years; (3) COVID-19 diagnosis based on polymerase chain reaction (PCR) testing; (4) Hypoxia (Oxygen saturation of less than or equal 92% on air, or PO2 < 60mmHg in arterial blood gas, or arterial partial pressure of oxygen (PaO )/fraction of inspired oxygen (FIO) of 300 or less) and patient requiring oxygen therapy (5) pneumonia confirmed by chest imaging. |
| Exclusion criteria | (1) Patients with mild disease not requiring oxygen therapy;
(2) Patients with normal CXR or CT scan; (3) Patients requiring ventilatory support (invasive or non-invasive); (4) Patients with a negative PCR test for SARS-CoV-2; (5) Patients with a history of allergy to plasma, sodium citrate or methylene blue, or those with a history of autoimmune disease or selective IGA deficiency. |
| Interventions | |
| Treatment
Standard care * |
|
| Control
Convalescent plasma (200 ml) Duration : 2 days | |
| Participants | |
| Randomized 40 participants (n1=20 / n2= 20) | |
| Characteristics of participants N=40 Mean age : 51.7 32 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=40 Critical: n=0 | |
| Primary outcome | |
| In the register Requirement for invasive ventilation [ Time Frame: through study completion up to 28 days ] | |
| In the report Requirement for invasive or non-invasive ventilation, and, in patients who required ventilation, the duration of ventilation. | |
| 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 |
Some concerns |
| General comment | In addition to the published/pre-print article, the study protocol and trial registry were used in data extraction and assessment of risk of bias. No statistical analysis plan was available. There were no substantive differences between the pre-print article, the study protocol and trial registry in terms of procedures, population, treatments and outcomes. The pilot study reached its pre-stated sample size. Adverse events were only reported for the intervention arm. On 18th of May, 2021, this study was updated based on the published report. |