Clearing the fog: Is HCQ effective in reducing COVID-19 progression: A randomized controlled trial

Objective To analyze the efficacy of Hydroxychloroquine (HCQ) plus standard of care (SOC) compared with SOC alone in reducing disease progression in Mild COVID-19 Design A single centre, open label randomized controlled trial Place and Duration Pulmonology department, Pak emirates Military Hospital (PEMH) from 10 April 2020 to 31 May 2020. Methodology Five hundred patients of both genders having age between 18-50 years who were PCR positive and had Mild COVID-19 were selected. Patients assigned to standard dose of HCQ (400mg 12 hourly day 1 then 200mg 12 hrly for next 4 days) plus SOC were 349 while 151 patients received SOC comprising of Vit C, Vit D, and Zinc only (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 standard of care treatment in Mild COVID-19 neither prevents disease progression nor is it significantly associated with successive PCR negativity on day 7 and 14. Trial registration NCT04491994 Ethical review of research project The research project titled “Clearing the fog: Is HCQ effective in reducing COVID-19 progression” has been reviewed by ethical review committee of Pak Emirates Military Hospital (PEMH) Rawalpindi and got legal and ethical approvals prior to initiation of the research work carried out on subject. All experiments were performed in accordance with the relevant guidelines and regulation. Grant of approval is attached as separate file.