COVIDMED – An early pandemic randomized clinical trial of losartan treatment for hospitalized COVID-19 patients
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SciScore for 10.1101/2022.01.12.22269095: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: COVID MED (NCT04340557) was approved by the Institutional Review Boards of Bassett Medical Center (Cooperstown, NY [April 3, 2020] [#1581969]), Goshen Health (Goshen, IN) and Reid Health (Richmond, IN).
Consent: Target recruitment was maximized by daily assessment of positive SARS-CoV-2 swab tests from Bassett’s laboratory in hospitalized patients with review of inclusion/exclusion criteria for all such patients by the study’s enrollment nurse and offering enrollment to all interested in participating after a comprehensive informed consent process (see Supplementary material for Informed Consent Form [ICF]).Sex as a biological variable not detected. Randomization Post-consent, patients … SciScore for 10.1101/2022.01.12.22269095: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: COVID MED (NCT04340557) was approved by the Institutional Review Boards of Bassett Medical Center (Cooperstown, NY [April 3, 2020] [#1581969]), Goshen Health (Goshen, IN) and Reid Health (Richmond, IN).
Consent: Target recruitment was maximized by daily assessment of positive SARS-CoV-2 swab tests from Bassett’s laboratory in hospitalized patients with review of inclusion/exclusion criteria for all such patients by the study’s enrollment nurse and offering enrollment to all interested in participating after a comprehensive informed consent process (see Supplementary material for Informed Consent Form [ICF]).Sex as a biological variable not detected. Randomization Post-consent, patients were randomly assigned by an unblinded enrollment research nurse in a 2:2:2:1 ratio in blocks to one of four groups using a computer-generated randomization schedule provided by the study’s statistician (without stratification): hydroxychloroquine, lopinavir/ritonavir, losartan, or placebo; this ratio was selected because early in the pandemic patients declined participation in trials with low likelihood of receiving ‘active’ drug. Blinding If crushed drug or drug in solution had to be administered (nasogastric/gastric tube), eye shields were used to maintain blinding. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data from CRFs and AE/SAE reports were entered into REDCap using secure login/password entry; data were deidentified in working documents which were available only to study investigators; all study identifying data will be destroyed/deleted upon publication to allow wider sharing if requested. REDCapsuggested: (REDCap, RRID:SCR_003445)Results 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:Study limitations included single-arm, nonrandomized, open-label design with external historical controls, and between-group imbalance. 34 of 347 screened patients were enrolled (10%). The second, an open-label RCT compared the ARB telmisartan and SOC vs. SOC alone in two hospitalized COVID-19 patients in Argentina up to 4 days post symptoms onset (earlier than our trial) [14]. The primary outcome was CRP at days 5 and 8. In an interim analysis, 40 telmisartan/SOC vs. 38 SOC were compared. Mean CRP was significantly lower in telmisartan/SOC vs. SOC groups at days 5 (24.2 vs. 51.1 mg/L [p<0.05]) and 8 (9.0 vs. 41.6 mg/L [p<0.05]). Median time to discharge was shorter with telmisartan, 9 vs. 15 days (p=0.01) and 30-day mortality trend favored telmisartan (5.26 vs. 11.76%, p=0.41); there were no differences for ICU admission, mechanical ventilation, and a composite of ICU admission, mechanical ventilation, and death; fewer patients receiving telmisartan needed oxygen at day 15 (2/4 vs. 13/14, p<0.05). No telmisartan related AEs occurred and BP was similar. 82 of 185 screened patients were enrolled (56% [higher than our trial]). The third, an open-label RCT compared the ARB losartan and SOC vs. SOC alone in 31 SHARP (San Diego) hospitalized patients with COVID-19 with mild hypoxia (requiring
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04340557 Completed Do Angiotensin Receptor Blockers Mitigate Progression to Acu… NCT04328012 Recruiting COVID MED Trial - Comparison Of Therapeutics for Hospitalize… 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.
- Thank you for including a protocol registration statement.
Results from scite Reference Check: We found no unreliable references.
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