Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: A randomized controlled trial
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Abstract
The novel coronavirus pandemic (COVID–19) represents a major public health problem and it is key to find a treatment that reduces mortality. Our objective was to estimate whether treatment with 400 mg/day of Hydroxychloroquine for 10 days reduces in-hospital mortality in subjects with severe respiratory disease due to COVID-19 compared with placebo.
Material and methods
A double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of Hydroxychloroquine for the treatment of severe disease by COVID-19 through an intention-to-treat analysis. Eligible for the study were adults aged more than 18 years with COVID-19 confirmed by RT-PCR and lung injury requiring hospitalization with or without mechanical ventilation. Primary outcome was 30-day mortality. Secondary outcomes: days of mechanical ventilation, days of hospitalization and cumulative incidence of serious adverse events.
Results
A total of 214 patients with COVID-19 were recruited, randomized and analyzed. They were hypoxemic with a mean SpO 2 of 65% ± 20, tachycardic (pulse rate 108±17 min- 1 ) and tachypneic (32 ±10 min- 1 ); 162 were under mechanical ventilation at randomization. Thirty-day mortality was similar in both groups (38% in Hydroxychloroquine vs. 41% in placebo, hazard ratio [HR] 0.88, 95% Confidence Interval [95%CI] 0.51–1.53). In the surviving participants, no significant difference was found in secondary outcomes.
Conclusion
No beneficial effect or significant harm could be demonstrated in our randomized controlled trial including 214 patients, using relatively low doses of Hydroxychloroquine compared with placebo in hospitalized patients with severe COVID-19.
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SciScore for 10.1101/2021.02.01.21250371: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: This report followed the CONSORT guidelines 13 and was approved by the Institutional Ethics Committees. Randomization This was a phase III, multicenter, randomized, double-blind, parallel-control clinical trial held primarily at the Mexican National Institute of Respiratory Diseases Ismael Cosío Villegas (INER), a referral center for respiratory diseases; and at two additional participating hospitals belonging to the network of High Specialty Regional Hospitals (Hospitales Regionales de Alta Especialidad) in Ixtapaluca and Oaxaca, Mexico. Blinding Blinding: Recruiters, patients, treating physicians, nursing staff, and the rest of the treating team, along with … SciScore for 10.1101/2021.02.01.21250371: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: This report followed the CONSORT guidelines 13 and was approved by the Institutional Ethics Committees. Randomization This was a phase III, multicenter, randomized, double-blind, parallel-control clinical trial held primarily at the Mexican National Institute of Respiratory Diseases Ismael Cosío Villegas (INER), a referral center for respiratory diseases; and at two additional participating hospitals belonging to the network of High Specialty Regional Hospitals (Hospitales Regionales de Alta Especialidad) in Ixtapaluca and Oaxaca, Mexico. Blinding Blinding: Recruiters, patients, treating physicians, nursing staff, and the rest of the treating team, along with the follow-up evaluation monitors and the data-entry personnel, were blinded to group assignment. Power Analysis Sample Size: The original design considered, under uncertainty of a pandemic in its initial phases, a total randomized population of 600 patients (300 per group), based on an estimation of a 50% reduction in mortality from 15% in the placebo group, with a study power of 80% and a two-tailed significance alpha of 0.05. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
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:Instead, limitations derived from insufficient personnel with proper training in intensive care, and the occasional scarcity of medicines, and Personal Protection Equipment. The frequency of nosocomial infection was high, although in Cox proportional hazard models the presence of these nosocomial infections did not increase mortality once mechanical ventilation was taken into account. Although this was a trial with proper randomization and blinding, demonstrated by the comparison of baseline characteristics of the treatment arms, reducing the possibility of biases due to known or unknown variables, the trial ended short of the planned sample size. Increasing the number of recruited patients proved very difficult with a growing number of refusals by patients, relatives, and treating physicians once the large trials, including RECOVERY, SOLIDARITY, and that supported by NIH, suspended their treatment arms with HCQ due to a lack of beneficial effect, although no harm from HCQ was reported. Information of these suspended trials traveled by newspapers and media 17, and reached the widespread population with a great impact, even before a proper peer-reviewed publication was available and analyzed, because of the considerable prestige and importance of the institutions responsible for the trials. It is understandable that in the middle of a pandemic, a rapid presentation of results of large, proper clinical trials may help to select the best treatments to improve patients or avoid d...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04315896 Active, not recruiting Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary I… 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 scite Reference Check: We found no unreliable references.
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