Trial NCT04342182
Publication Gharbharan A, Nat Commun, 2021 (published paper)
Dates: 2020-04-08 to 2020-06-14
Funding: Mixed (The Erasmusfoundation, Ypsilo and Health Holland)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / Netherlands Follow-up duration (days): 60 | |
| Inclusion criteria | Eligible patients were at least 18 years, admitted to a study site for COVID-19 and had clinical COVID-19 disease proven by a positive SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) test in the previous 96 hours. |
| Exclusion criteria | Patients with a documented IgA deficiency or on mechanical ventilation for >96 hours were excluded. |
| Interventions | |
| Treatment
Convalescent plasma 300 mL IV on the day of inclusion. A second dose could be administered after five days. |
|
| Control
Standard care Definition of Standard care: Off-label use of European Medicines Agency (EMA)-approved drugs as a treatment for COVID-19 was allowed in hospitals where this was part of the SoC. The use of experimental medication for COVID-19 was recorded in the eCRF for (hydroxy)chloroquine, lopinavir/ritonavir, and remdesivir | |
| Participants | |
| Randomized 86 participants (n1=43 / n2= 43) | |
| Characteristics of participants N=86 Mean age : NR 62 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=13 | |
| Primary outcome | |
| In the register Overall mortality [ Time Frame: until hospital discharge or a maximum of 60 days whichever comes first ] | |
| In the report The primary endpoint of the study was overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever came first. | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated 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 all available versions of the publication/pre-print, the study registry, protocol, and statistical analysis plan were used in data extraction and risk of bias assessment.
The April 15th update of the registry (start of trial April 8th, 2020. Follow-up 15 days) was used. Safety outcomes were specified after this but that was considered to be a retrospective update to the registry to be utilized for the risk of bias domain 5. The protocol was also very retrospective (May 11th, 2020). There is no change from the trial registration in the intervention and control treatments. Some pre-specified secondary outcomes and exclusion criteria were not included in the pre-print/publication. According to information on 'Acquisition of patients' in the supplementary file (pre-print), the eligibility criteria was adjusted during recruitment. Quote: "After the first 63 patients these criteria were modified to also include the exclusion criteria known IgA deficiency and >96 hours on invasive ventilation at time of screening." On 2nd of May, 2021, this study was updated based on the published report. |