Trial NCT04542941
Publication Kirenga B, BMJ Open Respir Res, 2021 (published paper)
Dates: 2020-09-23 to 2020-12-02
Funding: Public/non profit (Government of Uganda through the Makerere University Research and Innovations Fund)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Uganda
Follow-up duration (days): 28
Inclusion criteriaAdults with documented laboratory RT PCR confirmed SAR-CoV-2 infection; able to provide informed consent.
Exclusion criteriaPrior diagnosis of IgA deficiency; Inability to return for post discharge follow up
Interventions
Treatment
Convalescent plasma
1.4–2 mL/min over 2-3 hours, repeated 3 hours later
Control
Standard care ( / )
Definition of Standard care: The SOC was according to the Uganda COVID-19 case management guidelines
Participants
Randomized
136 participants (n1=69 / n2= 67)
Characteristics of participants
N=136
Mean age : NR
97 males
Severity : Mild: n=57 / Moderate: n=35/ Severe: n=31 Critical: n=0
Primary outcome
In the register
Time to viral clearance (RT-PCR negativity) [ Time Frame: 28 days ]
In the report
Time to viral clearance, defined by two consecutive negative SARS-CoV-2 RT-PCR test results.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated
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 prospective registry and supplemental appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plane was available. The reported primary outcome reflected that in the registry. One secondary outcome (clinical status on the modified WHO Ordinal Clinical Scale for clinical improvement) was not included in the registry as “improvement” but reported as deterioration (≥1-point increase in scale). The study achieved its target sample size.