Updated: Sep 19, 2021
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)
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 cures at days 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). On day 3, 74/92 (80.4%) participants on Doxycycline versus 77/95 (81.1%) on Hydroxychloroquine-Azithromycin -based protocols were asymptomatic (p=0.91). On day 10, 88/92 (95.7%) participants on Doxycycline versus 93/95 (97.9%) on Hydroxychloroquine-Azithromycin were asymptomatic (p=0.44). On 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 trials, assessing the efficacy and tolerance of Doxycycline to treat COVID-19
➢ It is one of the first to evaluate disease progression and needs 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 Azithromycin
➢ 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
Competing Interest Statement
The authors have declared no competing interests.
The study was partially sponsored by a special grant from the French Embassy in Cameroon. The study benefited from material support from the RSD institute Yaounde Cameroon and Yaounde Central Hospital.
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The study received ethical clearance from the Cameroon National Ethics Committee (2020/07/1585/L/CNERSH/SP).
All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.
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