Clearing the Fog: Is Hydroxychloroquine Effective in Reducing Coronavirus Disease-2019 Progression? A Randomized Controlled Trial

Abstract

Background: Hydroxychloroquine (HCQ) has been considered to treat Coronavirus disease 2019 (COVID-19) but data on efficacy is conflicting. we analyzed the efficacy of HCQ) in addition to standard of care (SOC) compared with SOC alone in reducing disease progression in Mild COVID-19 Methods: A single centre open label randomized controlled trial during 10th April to 31st May 2020 was conducted at Pak emirates Military Hospital (PEMH) Five hundred patients of both genders having age between 18-80 years with Mild COVID-19 were enrolled. Patients assigned to standard dose of HCQ plus SOC were 349 while 151 patients received SOC (control group). Primary outcome was progression of disease while secondary outcome was PCR negativity on day 7 and 14. The results were analyzed on SPSS version 23. P value <0.05 was considered significant. Results: Median age of intervention group (34 + 11.778 years) and control group (34 + 9.813 years). Disease progressed in 16 patients, 11 (3.15%) were in intervention group as compared to 5 (3.35%) in control group, (P value = 0.865). PCR negativity in intervention and control groups were (day 7, 182 (52.1%) vs. 54 (35.7%) (P value = 0.001), (day 14, 244 (69.9%) vs. 110 (72.8%) (P value = 0.508). Consecutive PCR negativity at day 7 and 14 was observed in 240 (68.8%) in intervention group compared to 108 (71.5%) in control group. (P value = 0.231). Conclusion: Addition of HCQ to SOC in Mild COVID-19 neither stops disease progression nor help in early and sustained viral clearance. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04491994 ### Funding Statement This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethical Review Committee Pak Emirates Military Hospital All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has b…