Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ)
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SciScore for 10.1101/2021.08.19.21262275: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The HERO-HCQ trial was reviewed by the Duke University School of Medicine Institutional Review Board and approved by the Western Institutional Review Board (Pro00105274).
Consent: Participants: Eligible participants provided informed consent, were age 18 or older, and were working in a health care setting with potential exposure to patients with COVID-19.Sex as a biological variable not detected. Randomization Study Design: HERO-HCQ was a multicenter, double-blind, randomized, parallel-group study designed to evaluate the superiority of HCQ vs. placebo for COVID-19 pre-exposure prophylaxis in HCWs. Blinding not detected. Power Analysis This sample size was expected to provide greater than 80% … SciScore for 10.1101/2021.08.19.21262275: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The HERO-HCQ trial was reviewed by the Duke University School of Medicine Institutional Review Board and approved by the Western Institutional Review Board (Pro00105274).
Consent: Participants: Eligible participants provided informed consent, were age 18 or older, and were working in a health care setting with potential exposure to patients with COVID-19.Sex as a biological variable not detected. Randomization Study Design: HERO-HCQ was a multicenter, double-blind, randomized, parallel-group study designed to evaluate the superiority of HCQ vs. placebo for COVID-19 pre-exposure prophylaxis in HCWs. Blinding not detected. Power Analysis This sample size was expected to provide greater than 80% power to detect a 1% absolute decrease (20% relative decrease) in COVID-19 infection rates between treatment arms. Table 2: Resources
Antibodies Sentences Resources Baseline assessments included a nasopharyngeal swab for SARS-CoV-2 and a blood sample to assess baseline SARS-CoV-2 nucleocapsid IgG antibody status. SARS-CoV-2 nucleocapsid IgGsuggested: 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:Strengths and Weaknesses in Context: The original study design was powered to show a 20% relative treatment effect assuming a 5% event rate in the placebo arm. However, due to slowed enrollment early in the study, the study was amended to decrease the sample size and hence the power, increasing the detectable relative treatment effect to 50%. Thus, the study was underpowered to detect a small treatment effect. Also, while the partially remote nature of the trial was novel and improved feasibility, particularly during a pandemic, it also resulted in the limitation that we did not have laboratory confirmation for COVID-19–like illness. Early in the pandemic, in some regions, testing was not performed per local policies in HCW with suspected infection and mild or moderate symptoms. These events were defined as suspected cases and were combined with the confirmed cases in the primary outcome. This also resulted in few confirmed COVID-19 infections; thus, our primary outcome was primarily suspected COVID-19 clinical infection. While the study did not have frequent PCR testing, testing at entry and end-of-study intervention showed low cross-sectional asymptomatic rates of viral shedding in the study population. Similarly, the seroconversion rate was low (0.6%) over the 30-day intervention period. These low rates of asymptomatic shedding and seroconversion suggest that SARS-CoV-2 infection was lower than expected in the study population and may be overestimated by our composite prim...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04334148 Completed Healthcare Worker Exposure Response and Outcomes of Hydroxyc… NCT04342806 Recruiting Healthcare Worker Exposure Response and Outcomes (HERO) Regi… 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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