Clearing the fog: Is HCQ effective in reducing COVID-19 progression: A randomized controlled trial
Sultan Mehmood Kamran, Zill E Humayun Mirza, Brig Arshad Naseem, Farrukh Saeed, Rizwan Azam, Naqeeb Ullah, Wazir Ahmad, Salman Saleem
doi:10.1101/2020.07.30.20165365
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 10 th April to 31 st 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.
Conflict of interest statement Manuscript titled "Clearing the fog: Is HCQ effective in reducing COVID-19 progression: A randomized controlled trial". The authors whose names are mentioned in author list certify that they have NO affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers' bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.
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DOI record:
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"abstract": "<jats:title>Abstract</jats:title><jats:sec><jats:title>Objective</jats:title><jats:p>To analyze the efficacy of Hydroxychloroquine (HCQ) plus standard of care (SOC) compared with SOC alone in reducing disease progression in Mild COVID-19</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>A single centre, open label randomized controlled trial</jats:p></jats:sec><jats:sec><jats:title>Place and Duration</jats:title><jats:p>Pulmonology department, Pak emirates Military Hospital (PEMH) from 10 April 2020 to 31 May 2020.</jats:p></jats:sec><jats:sec><jats:title>Methodology</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration</jats:title><jats:p><jats:bold>NCT04491994</jats:bold></jats:p></jats:sec><jats:sec><jats:title>Ethical review of research project</jats:title><jats:p>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.</jats:p></jats:sec>",
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