Publication AlQahtani M, medRxiv, 2020 (preprint)
Dates: 2020-04-15 to 2020-06-22
Funding: Public/non profit (Ministry of Health Bahrain and the College of Surgeons in Ireland-Bahrain)
Conflict of interest: No
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 history of allergy to plasma, sodium citrate or methylene blue, or those with a history of autoimmune disease or selective IGA deficiency.
Convalescent plasma (200 ml)Co-Intervention: Standard care
Duration : 2 days
Definition of Standard care: The standard supportive treatment included control of fever (paracetamol) and possible therapy including antiviral medications, Tocilizumab and antibacterial medication.
40 participants (n1=20 / n2= 20)
|Characteristics of participants|
Mean age : 51.7
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=40 Critical: n=0
|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.
Yes. In English
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to the 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.|