Trial NCT04516811
Publication PROTECT-Patient - van den Berg K, Sci Rep (2022) (published paper)
Dates: 2020-09-30 to 2021-01-14
Funding: Public/non profit (The ELMA South Africa Foundation; Allan & Gill Gray Philanthropy LIMITED; Wellcome; the South African Medical Research Council)
Conflict of interest: No

Methods
RCT
Blinding: triple blinding
Location : Multicenter / South Africa
Follow-up duration (days): 28
Inclusion criteria
  • Hospitalized patients
  •  ≥ 18 years of age
  • laboratory confirmation of SARS-CoV-2 infection by reverse transcriptase polymerase chain reaction (RT-PCR) on any respiratory sample
  • radiologic evidence of pneumonia with pulmonary infiltrates on chest X-ray, oxygen saturation (SpO2) of < 94% on room air
  • requiring non-invasive oxygen therapy.
Exclusion criteria
  • Mechanically ventilated
  • survival for < 24 h expected
  • co-enrolment into another investigational therapy trial.
Interventions
Treatment
Convalescent plasma
Single infusion of 200–250 mL administered over 20–30 min
Control
Placebo

Participants
Randomized
participants :
Convalescent plasma=52
Placebo=51
Characteristics of participants
N= 103
Mean age : NR
42 males
Severity : Mild: n=0 / Moderate: n=82 / Severe: n=21 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Clinical Improvement [ Time Frame: Day 28 ] Proportion of participants with successful treatment outcome, defined as clinical improvement (≥ 2 points on WHO R&D BOSCI 1) by Day 28 post-randomisation.
In the report
Successful treatment at Day 28 post-randomization, defined as acute care hospital discharge or clinical improvement of ≥ 2 points on an ordinal scale recommended by the World Health Organization
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
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
Low
General comment In addition to the published article, the prospective trial registry was used in data extraction and assessment of risk of bias. Neither protocol not statistical analysis plan was available. The trial (n = 107) did not achieve its target sample size (n = 600) as it was stopped early for futility by the Data and Safety Monitoring Board. There is no change from the trial registration in the intervention and control treatments. The primary outcome in the article reflects that in the registry (2-point clinical improvement). Some outcomes from the registry are not reported in the paper (e.g., negative SARS-CoV-2 conversion at day 28 and time to negative conversion). Data for Time to death and Time to clinical improvement were provided in plots but detailed summary statistics were not reported (i.e., hazard ratios).