Trial NCT04385199
Publication NCT04385199, Unpublished (2022) (results posted on registry)

Funding: Not reported/unclear
Conflict of interest: *

Methods
RCT
Blinding: Unblinded
Location : Single center / USA
Follow-up duration (days): 28
Inclusion criteria
  • Patients with laboratory confirmed COVID-19 diagnosed using qualitative reverse transcriptase-polymerase chain reaction (qRT-PCR) who are hospitalized with severe COVID-19 respiratory disease
  • Age > 18 with one or more of the following: Dyspnea Respiratory rate >= 30 breaths/min - Oxygen saturation <=93% PaO2/FiO2 <300 - Bilateral airspace opacities on chest radiograph at 24 to 48 hours
Exclusion criteria
  • Acute myocardial infarction in past 30 days Acute stroke in past 30 days VV ECMO VA ECMO
Interventions
Treatment
Convalescent plasma
200 mL single dose IV infusion over 3 hours

Control
Standard care

Participants
Randomized
participants :
Convalescent plasma=20
Standard care=10
Characteristics of participants
N= 30
Mean age : NR
17 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
Change in Respiratory Disease Severity [ Time Frame: day 3 post transfusion ]
Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion
In the report
NR
Documents
available

Protocol

Yes. In English

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
Some concerns
General comment This is an unpublished trial whose results have been reported in ClinicalTrials.gov. The trial registry and protocol were used in data extraction and assessment of risk of bias. The trial was registered retrospectively. No important changes were made to primary or secondary outcomes after recruitment start according to the prospective protocol. The trial achieved the target sample size specified in the registry (n=30).