Trial NCT04600440
Publication Holm K, BMC Res Notes (2021) (published paper)
Dates: 2020-06-01 to 2021-01-30
Funding: Public/non profit (Skåne Region)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Sweden
Follow-up duration (days): 28
Inclusion criteria
  • Admitted to the hospital
  • nasopharyngeal swab positive for SARS-CoV-2 in RT-PCR no later than 4 days prior to inclusion
  • need for supplemental oxygen treatment to keep peripheral oxygen saturation > 93%
  • written informed consent.
Exclusion criteria
  • Age below 18
  • a habitual oxygen saturation below 94%
  • inability to give informed consent
  • severe immunosuppression.
Interventions
Treatment
Convalescent plasma
200-250 mL/day intravenously over 30 min for three consecutive days.
Control
Standard care

Participants
Randomized
participants :
Convalescent plasma=18
Standard care=15
Characteristics of participants
N= 33
Mean age : NR
19 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
Number of days in need of oxygen [ Time Frame: 28 days ]
In the report
Number of days within 28 days after inclusion with a need for oxygen therapy to keep an oxygen saturation above 93%.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

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 registry (retrospective) and supplementary appendix were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcome in the article reflects that in the registry. The longest follow up in the registry (3 months for two secondary outcomes, mortality and discharge) was not reported, but this change was declared in the article. Recruitment was terminated because studies were published that indicated that convalescent plasma was ineffective in the type of patients included in the study per inclusion and exclusion criteria and as a result of vaccination of the elderly.