Efficacy and safety of hydroxychloroquine in healthcare professionals with mild SARS-CoV-2 infection: Prospective, non-randomized trial
Antonia Agusti, Elena Guillen, Alfonso Ayora, Andres Anton, Cristina Aguilera, Xavier Vidal, Cristina Andres, Manuel Alonso, Meritxell Espuga, Juliana Esperalba, Mª Queralt Gorgas, Benito Almirante, Esteban Ribera
Enfermedades Infecciosas y Microbiología Clínica, doi:10.1016/j.eimc.2020.10.023
Objectives: To assess the efficacy and safety of hydroxychloroquine (HCQ) compared with no treatment in healthcare workers with mild SARS-CoV-2 infection. Methods: Prospective, non-randomized study. All health professionals with confirmed COVID-19 between April 7 and May 6, 2020, non-requiring initial hospitalization were asked to participate. Patients who accepted treatment were given HCQ for five days (loading dose of 400 mg q12 h the first day followed by200 mg q12 h). Control group included patients with contraindications for HCQ or who rejected treatment. Study outcomes were negative conversion and viral dynamics of SARS-CoV-2, symptoms duration and disease progression. Result: Overall, 142 patients were enrolled: 87 in treatment group and 55 in control group. The median age was 37 years and 75% were female, with few comorbidities. There were no significant differences in time to negative conversion of PCR between both groups. The only significant difference in the probability of negative conversion of PCR was observed at day 21 (18.7%, 95%CI 2.0-35.4). The decrease of SARS-CoV-2 viral load during follow-up was similar in both groups. A non significant reduction in duration of some symptoms in HCQ group was observed. Two patients with HCQ and 4 without treatment developed pneumonia. No patients required admission to the Intensive Care Unit or died. About 50% of patients presented mild side effects of HCQ, mainly diarrhea. Conclusions: Our study failed to show a substantial benefit of HCQ in viral dynamics and in resolution of clinical symptoms in health care workers with mild COVID-19.
Ethics The study was conducted according to international ethical recommendations. In accordance with the national directives in relation to post-authorization studies, the study was approved by the Ethics Committee of Clinical Investigation of the Vall d'Hebron University Hospital (Institutional Review Board -03/04/2020) and registered on the European Union electronic Register of Post-Authorization Studies (EU PAS Register Number EUPAS34570). This trial had no financial support. Laboratorios Rubió contributed to the study with the required doses of hydroxychloroquine (Dolquine). Laboratorios Rubió had no role in study design, data collection and interpretation, or the decision to submit the work for publication.
Conflict of interest All authors declare no conflict of interest.
Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at doi:10.1016/j.eimc.2020.10.023.
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