Efficacy and Safety of Ivermectin and Hydroxychloroquine in Patients with Severe COVID-19: A Randomized Controlled Trial
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Abstract
During the first year of the COVID-19 pandemic, unauthorized drugs were widely used. Ivermectin and hydroxychloroquine are drugs that inhibit viral replication in vitro and that have been used in several medical centers. This clinical trial analyzes their efficacy in hospitalized patients with moderate COVID-19. Methods: This a controlled, clinical, randomized, double-blind trial that included hospitalized patients with COVID-19-induced pneumonia, without severe respiratory failure. Patients were randomized to one of three groups: Group 1—hydroxychloroquine, 400 mg every 12 h on the first day and, subsequently, 200 mg every 12 h for 4 days; Group 2—ivermectin, 12 mg or 18 mg, according to patient weight; and Group 3—placebo. At inclusion, blood samples for arterial blood gases and biochemical markers were obtained. The primary outcome was established as the length of stay due to patient improvement and the rate of respiratory deterioration or death. Results: During the month of August 2020, the admission of patients requiring hospitalization mostly encompassed cases with severe respiratory failure, so we ended the recruitment process and analyzed the data that was available at the time. One hundred and six (106) patients with an average age of 53 yrs (±16.9) were included, with a greater proportion of males (n = 66, 62.2%). Seventy-two percent (72%) (n = 76) had an associated comorbidity. Ninety percent (90%) of patients were discharged due to improvement (n = 96). The average duration of hospitalization was 6 days (IQR, 3–10). No difference in hospitalization duration was found between the treatment groups (Group1: 7 vs. Group 2: 6 vs. Group 3: 5, p = 0.43) nor in respiratory deterioration or death (Group 1: 18% vs. Group 2: 22.2% vs. Group 3: 24.3%, p = 0.83). Conclusions: In non-critical hospitalized patients with COVID-19 pneumonia, neither ivermectin nor hydroxychloroquine decreases the number of in-hospital days, respiratory deterioration, or deaths.
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SciScore for 10.1101/2021.02.18.21252037: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The study protocol was approved by the Ethics Committee of the Hospital Centenario Miguel Hidalgo on April 15, 2020, with the assigned number 2020-R-24. Randomization This is a controlled, randomized, double-blind, clinical trial of patients with pneumonia secondary to SARS-CoV-2 infection and that fulfilled hospitalization criteria. Blinding Each patient had a vial for the initial dose in order to blind the ivermectin and a second vial for subsequent doses. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources It was also included in the ClinicalTrials website with the identifier … SciScore for 10.1101/2021.02.18.21252037: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The study protocol was approved by the Ethics Committee of the Hospital Centenario Miguel Hidalgo on April 15, 2020, with the assigned number 2020-R-24. Randomization This is a controlled, randomized, double-blind, clinical trial of patients with pneumonia secondary to SARS-CoV-2 infection and that fulfilled hospitalization criteria. Blinding Each patient had a vial for the initial dose in order to blind the ivermectin and a second vial for subsequent doses. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources It was also included in the ClinicalTrials website with the identifier NCT04391127. ClinicalTrialssuggested: (ClinicalTrials.gov, RRID:SCR_002309)Microsoft Excel 2013 and STATA version 11.1 software were used for analysis. Microsoft Excelsuggested: (Microsoft Excel, RRID:SCR_016137)STATAsuggested: (Stata, RRID:SCR_012763)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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04391127 Completed Hydroxychloroquine and Ivermectin for the Treatment of COVID… 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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