“Efficacy and Safety of Fixed Combination of Hydroxychloroquine with Azithromycin Versus Hydroxychloroquine and Placebo in Patients with Mild COVID-19: Randomized, double blind, Placebo controlled trial”
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Abstract
To determine the efficacy and safety of fixed combination of hydroxychloroquine/azithromycin (HCQ+AZT) compared to hydroxychloroquine (HCQ) alone or placebo in mild COVID-19 outpatients to avoid hospitalization.
Materials and methods
This randomized, parallel, double-blind clinical trial included male and female patients aged 18 and 76 years non COVID vaccinated, who were diagnosed with mild COVID-19 infection. All patients underwent liver and kidney profile test, as well as a health questionnaire and clinical revision to document that they did not have uncontrolled comorbidities. They were randomly assigned to one of the three treatment arms: 1) hydroxychloroquine with azithromycin 200 mg/250 mg every 12 hours for five days followed by hydroxychloroquine 200 mg every 12 hours for 5 days; 2) hydroxychloroquine 200 mg every 12 hours for ten days; or 3) placebo every 12 hours for ten days. The primary outcome of the study was hospitalization, while the secondary outcomes were disease progression, pneumonia, use of supplemental oxygen, and adverse events. This study was registered in clinicaltrials.gov with the NCT number of 04964583.
Results
A total of 92 participants were randomized. Of whom, 30 received HCQ+AZT, 31 received HCQ, and 31 received placebo. The median age was 37 years, 27.2% of the participants had comorbidities, and the global incidence of hospitalization was 2.2%. The incidence of hospitalization was 6.7% (2/30) in the HCQ+AZT group compared to the HCQ or placebo groups, in which there were no hospitalizations. Progression of disease was higher in the HCQ group [RR=3.25 (95% CI, 1.19-8.87)] compared with placebo group. There was no statistical difference between the HCQ+AZT group and the placebo group in progression of disease. The incidence of pneumonia was 30% in the HCQ+AZT group, 32.2% in the HCQ group, and 9.6% in the placebo group (HCQ + AZT vs Placebo; p=0.06). There was a significant risk of pneumonia versus placebo only in the HCQ group [RR=3.33 (95% CI, 1.01-10.9)]. Supplemental oxygen was required by 20% (6/30) of the patients in the HCQ+AZT group, 6.4 (2/31) of the patients in the HCQ group, and 3.2% (1/31) of the patients in the placebo group,[(HCQ + AZT vs Placebo; p=0.100), (HCQ vs Placebo, p=0.610)]. There was no statistical difference between groups for negative test (PCR) on day 11. The most frequent adverse events were gastrointestinal symptoms. No lengthening of the QT interval was observed in patients receiving HCQ+AZT or HCQ.
Conclusion
The use of HCQ+AZT does not decrease the risk of hospitalization in patients with mild COVID-19. The use of HCQ increases the risk of progression and pneumonia.
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SciScore for 10.1101/2022.04.06.22273531: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The protocol was approved by the National Research Committee institution’s review board of the IMSS with the number R-2020-785-138 and by COFEPRIS, the Mexican drug regulatory agency.
Consent: Written informed consent was obtained from each of the included participants.Sex as a biological variable Patients with cardiac disorders with delayed cardiac conduction (QT segment ≥ 450 ms), pregnant or lactating women, patients with hypersensitivity to study drugs, patients with chronic renal failure with (eGFR<40 mL/min), patients with a history of retinopathy or macular degeneration, known Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency, patients with liver disease, cirrhosis or those … SciScore for 10.1101/2022.04.06.22273531: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The protocol was approved by the National Research Committee institution’s review board of the IMSS with the number R-2020-785-138 and by COFEPRIS, the Mexican drug regulatory agency.
Consent: Written informed consent was obtained from each of the included participants.Sex as a biological variable Patients with cardiac disorders with delayed cardiac conduction (QT segment ≥ 450 ms), pregnant or lactating women, patients with hypersensitivity to study drugs, patients with chronic renal failure with (eGFR<40 mL/min), patients with a history of retinopathy or macular degeneration, known Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency, patients with liver disease, cirrhosis or those using the following medications: colchicine, ergotamine, dihydroergotamine, citalopram, hydroxyzine, domperidone, piperazine, antiarrhythmic drugs class IA and III and antidepressant medications were excluded from the study. Randomization Trial design: This study was designed as a multicenter, parallel, double-blind, randomized clinical trial. Blinding not detected. Power Analysis 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: 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 NCT04964583 Recruiting Hidroxicloroquina With Azitromicina Versus Hidroxicloroquina… 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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