A multicenter randomized open-label clinical trial for convalescent plasma in patients hospitalized with COVID-19 pneumonia
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SciScore for 10.1101/2020.08.26.20182444: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Oral informed consent (to avoid paper handling) was obtained from all the patients.
IRB: The trial was approved by the Research Ethics Committee of the Hospital Universitario Puerta de Hierro Majadahonda and conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonization.Randomization All patients received standard of care (SOC), including all supportive and specific treatments with off-label marketed medicines used according to local or national recommendations, and were randomly assigned in a 1:1 ratio to receive a single unit of CP (250-300 mL). Blinding not detected. Power Analysis Sta… SciScore for 10.1101/2020.08.26.20182444: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Oral informed consent (to avoid paper handling) was obtained from all the patients.
IRB: The trial was approved by the Research Ethics Committee of the Hospital Universitario Puerta de Hierro Majadahonda and conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonization.Randomization All patients received standard of care (SOC), including all supportive and specific treatments with off-label marketed medicines used according to local or national recommendations, and were randomly assigned in a 1:1 ratio to receive a single unit of CP (250-300 mL). Blinding not detected. Power Analysis Statistical Analysis: A sample of 278 patients (139 per arm) was planned assuming 20% rate of worsening in the control group and an absolute reduction of 10% in the CP group, with 80% statistical power and 2.5% one-sided alpha level (5% two-sided). Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Investigators were instructed to actively monitor for the appearance of predefined AE of Special Interest: TRALI and ADE (antibody-dependent enhancement of infection). antibody-dependent enhancement of infection).suggested: 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:Our data contribute to the evidence emerging from RCT, which despite the limitations of insufficient recruitment, bring together some shared conclusions valid for other potential studies and for clinical management. First, administration of CP in COVID-19 patients appears to be safe also in a well-monitored, randomized, controlled design. Second, they give support to studying CP earlier in the disease course in less-severe cases, rather than in advanced severe cases, in particular those in ICU. This study has limitations. It is not blinded, but nevertheless, concealment of assignation was well preserved, all patients underwent a well-established standard treatment with no evident between-groups differences in treatment after enrolment. Its most relevant limitation is premature closure with a lower than expected number of patients and events. This clearly limits the identification and analysis of potential changes in many endpoints and patients’ subgroups and hampers our ability to draw definitive conclusions for the general population. With all three RCT available on CP in COVID-19 sharing low recruitment and premature closure, we must revise the unique difficulties that conduction of such RCT appear to face. Under the threat of a severe pandemic, the strong natural desire from clinicians, health systems and the society at large to prevent morbidity and mortality is commendable. However, in a situation of need, cognitive bias can make us all assume unproven efficacy without t...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04345523 Recruiting Convalescent Plasma Therapy vs. SOC for the Treatment of COV… 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.
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