Doxycycline is a safe alternative to Hydroxychloroquine + Azithromycin to prevent clinical worsening and hospitalization in mild COVID-19 patients: An open label randomized clinical trial (DOXYCOV)
This article has been Reviewed by the following groups
Listed in
- Evaluated articles (ScreenIT)
Abstract
Objective
We aimed to compare the safety and efficacy of a doxycycline-based regimen against the national standard guidelines (Hydroxychloroquine plus Azithromycin) for the treatment of mild symptomatic COVID-19.
Methods
We conducted an open-label, randomized, non-inferiority trial, in Cameroon comparing Doxycycline 100mg, twice daily for 7 days versus Hydroxychloroquine, 400 mg daily for 5 days and Azithromycin 500mg at day 1 and 250mg from day 2 through 5, in mild COVID-19 patients. Clinical improvement, biological parameters and adverse events were assessed. The primary outcome was the proportion of clinical cure at day 3, 10 and 30. Non-inferiority was determined by the clinical cure rate between protocols with a 20 percentage points margin.
Results
194 participants underwent randomization and were treated with Doxycycline (n=97) or Hydroxychloroquine-Azithromycin (n=97). At day 3, 74/92 (80.4%) participants on Doxycycline versus 77/95 (81.1%) on Hydroxychloroquine-Azithromycin -based protocols were asymptomatic (p=0.91). At day 10, 88/92 (95.7%) participants on Doxycycline versus 93/95 (97.9%) on Hydroxychloroquine-Azithromycin were asymptomatic (p=0.44). At day 30 all participants were asymptomatic. SARS-CoV2 PCR was negative at Day 10 in 60/92 (65.2%) participants allocated to Doxycycline and 63/95 (66.3%) participants allocated to Hydroxychloroquine-Azithromycin. None of the participants were admitted for worsening of the disease after treatment initiation.
Conclusion
Doxycycline 100 mg twice daily for 7 days is as effective and safe as Hydroxychloroquine-Azithromycin, for preventing clinical worsening of mild symptomatic or asymptomatic COVID-19, and achieving virological suppression.
Strengths and Limitations
This study is one of the first randomized trial, assessing the efficacy and tolerance of Doxycycline to treat COVID-19
It is one of the first to evaluate disease progression and need to hospitalization in mild or asymptomatic COVID-19
Patients will not receive identical treatments
Doxycycline has advantages in terms of availability, safety and cost compared to Hydroxychloroquine and Azytromycin
Though this study has encounter 7 lost to follow-up, this does not have a major influence on our results
These data will assist clinicians in their daily practice, and provide a new tool for the fight against COVID-19
Article activity feed
-
SciScore for 10.1101/2021.07.25.21260838: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: All participants gave written informed consent before any trial procedures were performed. Sex as a biological variable not detected. Randomization Study design: The DOXYCOV trial, was an open-label, randomized, non-inferiority trial, to evaluate the safety and efficacy of Doxycycline therapy versus Cameroon National Standard therapy (Hydroxychloroquine + Azithromycin) in ambulatory patients with mild symptomatic, or asymptomatic COVID-19. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources All statistical analyses were conducted using Spss version 23.0. Spsssuggested: (SPSS, RRID:SCR_002865)Results from OddPub: We did not detect …
SciScore for 10.1101/2021.07.25.21260838: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: All participants gave written informed consent before any trial procedures were performed. Sex as a biological variable not detected. Randomization Study design: The DOXYCOV trial, was an open-label, randomized, non-inferiority trial, to evaluate the safety and efficacy of Doxycycline therapy versus Cameroon National Standard therapy (Hydroxychloroquine + Azithromycin) in ambulatory patients with mild symptomatic, or asymptomatic COVID-19. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources All statistical analyses were conducted using Spss version 23.0. Spsssuggested: (SPSS, RRID:SCR_002865)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 NCT04715295 Recruiting Safety and Efficacy of Doxycycline and Rivaroxaban in 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.
Results from scite Reference Check: We found no unreliable references.
-
