Efficacy and safety of convalescent plasma versus standard care in hospitalized patients with COVID-19 from the Peruvian Social Security Health System: open-label, randomized, controlled clinical trial
medrxiv(2022)
摘要
OBJECTIVES To assess the efficacy and safety of convalescent plasma plus standard of care (CP + SoC) compared with standard of care (SoC) alone in patients hospitalized for moderate to severe COVID-19 who do not yet require mechanical ventilation.
METHODS Phase 2 randomized, parallel-group, randomized, open-label, controlled, superiority, single-center clinical trial. This clinical trial has been registered in REPEC with the following ID: 013-20. Hospitalized adult patients with moderate to severe COVID-19 were enrolled. The allocation ratio was 1:1 in a variable-size permuted block randomization scheme. The primary outcome was death 28 days after the intervention. Secondary outcomes were mortality at 14 and 56 days, time to death at 56 days, time in the ICU at 28 days, time on a mechanical ventilator at 28 days, frequency of adverse events, and frequency of serious adverse events.
RESULTS A total of 64 participants were enrolled, 32 were assigned to CP + SoC, and 32 to SoC. One participant assigned to CP + SoC withdrew his informed consent before applying the treatment. At day 28, there were no statistically significant differences for the primary outcome between the CP + SoC and SoC groups (relative risk: 2.06; 95%CI 0.73 to 7.11; p = 0.190). No differences were found in the incidences of mortality at 56 days (hazard ratio: 2.21; 95%CI 0.66 to 7.33; p = 0.182), admission to the ICU at 28 days (sub-hazard ratio: 2.06; 95%CI 0.57 to 8.55; p = 0.250), admission to mechanical ventilation at 28 days (sub-hazard ratio: 2.19; 95%CI 0.57 to 8.51; p = 0.260). Estimates for days 14 were similar. No infusion-related adverse events were reported during the study. There were no statistically significant differences in the frequency of any adverse events (odds ratio: 2.74; 95%CI 0.90 to 9.10; p = 0.085) or the frequency of serious adverse events (odds ratio: 3.60; 95%CI 0.75 to 26.1; p = 0.75).
CONCLUSIONS No evidence was found that CP had a significant effect in reducing 28-day mortality. There was also no evidence that the frequency of adverse events was higher in those who received CP + SoC than those who received only SoC.
### Competing Interest Statement
The authors have declared no competing interest.
### Clinical Trial
This clinical trial has been registered in the Peruvian Registry of Clinical Trials (REPEC, by Spanish acronym) with the following ID: PER-013-20.
### Funding Statement
This clinical trial has been co-financed by two institutions of the Government of Peru, the Institute for the Evaluation of Technologies in Health and Research - IETSI of the Social Security of Health (EsSalud) and the National Council of Science, Technology and Technological Innovation (CONCYTEC) through peer-reviewed external financing: the National Fund for Scientific Research, Technological Development and Technological Innovation (FONDECYT), subsidy (Nº 068-2020-FONDECYT). This grant was awarded to CV, IN, AS, AC, MO, JLM, YH, PSB and RA. The funders had no role in study design, data collection and analysis, decision to publish, or manuscript preparation.
### Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The study was approved by the Transitory National Research Ethics Committee (CNTEI) -COVID-19 through Certificate of Approval - CNTEI-007-2020 dated June 19, 2020. The study is registered in the Peruvian Registry of Clinical Trials (REPEC) with code PER-013-20 (23) and was approved by the National Institute of Health through Directorial Resolution 198-2020-OGITT-INS dated June 25, 2020.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
Yes
The raw data was generated at the Institute for the Evaluation of Technologies in Health and Research - IETSI of Peru's Social Security of Health (EsSalud). Restrictions apply to the public availability of these data due to institutional patient data sharing policies. However, the data is available upon reasonable request from the author.
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关键词
convalescent plasma,clinical trial,patients,open-label
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