Convalescent Plasma in Critically ill Patients with Covid-19
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Abstract
BACKGROUND
The evidence for benefit of convalescent plasma for critically ill patients with Covid-19 is inconsistent. We hypothesized that convalescent plasma would improve outcomes for critically ill adult patients with Covid-19.
METHODS
In an ongoing adaptive platform trial, critically ill patients with confirmed Covid-19, defined as receiving intensive care-level organ support, were randomized to open-label convalescent plasma or not (i.e., control group). The primary end point was organ support-free days (i.e., days alive and free of ICU-based organ support) up to day 21. The primary analysis was a Bayesian cumulative logistic model with predefined criteria for superiority or futility. An odds ratio greater than 1 represented improved survival, more organ support–free days, or both.
RESULTS
The convalescent plasma intervention was stopped after pre-specified criteria for futility were met. At that time, 1084 participants had been randomized to convalescent plasma and 916 to no convalescent plasma (control). The median organ support-free days were 0 (interquartile range, -1 to 16) for the convalescent plasma group and 3 (interquartile range, -1 to 16) days for the control group. The median adjusted odds ratio (OR) was 0.97 (95% credible interval 0.83 to 1.15) and posterior probability of futility (OR < 1.2) was 99.4% for convalescent plasma compared to control. In-hospital mortality was 37.3% (401/1075) in convalescent plasma group, and 38.4% (347/904) in controls. The observed treatment effects were consistent across primary and secondary outcomes.
CONCLUSIONS
In critically ill adults with confirmed Covid-19, treatment with convalescent plasma, did not improve clinical outcomes.
Clinicaltrials.gov: NCT02735707
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SciScore for 10.1101/2021.06.11.21258760: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
Antibodies Sentences Resources All convalescent plasma used in the trial were tested for SARS-CoV-2 antibodies and met a minimum titer criterion prior to administration. SARS-CoV-2suggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:The trial has limitations. The trial used an open-label design, although clinician and patient awareness of trial assignment likely had minimal effect on the primary outcome. …
SciScore for 10.1101/2021.06.11.21258760: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
Antibodies Sentences Resources All convalescent plasma used in the trial were tested for SARS-CoV-2 antibodies and met a minimum titer criterion prior to administration. SARS-CoV-2suggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:The trial has limitations. The trial used an open-label design, although clinician and patient awareness of trial assignment likely had minimal effect on the primary outcome. Only 85.9% of participants received convalescent plasma in the intervention group as per protocol and 0.6% of patients in the control group received convalescent plasma, however, this is unlikely to have biased the results towards null, as the per protocol analyses were similar to the primary analysis. Although most participants received very high titer convalescent plasma, viral neutralization properties were not measured prior to administration. Finally, the trial has only been able to test the potential effectiveness of convalescent plasma in critically ill patients and it remains possible that convalescent plasma or other high-titer antibody-based therapy (alone or in combination with anti-viral chemotherapy) may have a therapeutic effect earlier in the disease process or in some patient groups.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT02735707 Recruiting Randomized, Embedded, Multifactorial Adaptive Platform Trial… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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