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Clearing the Fog: Is Hydroxychloroquine Effective in Reducing Coronavirus Disease-2019 Progression? A Randomized
Sultan M Kamran1, Hussain Abdul Moeed2, Zill-E-Humayun Mirza2
1Pulmonology and Critical Care, Pak Emirates Military Hospital, Rawalpindi, PAK.
Insights
Hydroxychloroquine (HCQ) did not improve disease progression or viral clearance in mild COVID-19 patients when added to standard care. This study found no significant benefit of HCQ over standard care alone for mild coronavirus disease 2019.
Area of Science:
- Infectious Diseases
- Pharmacology
- Clinical Medicine
Background:
- Conflicting data exists regarding the efficacy of hydroxychloroquine (HCQ) for treating COVID-19.
- Mild COVID-19 patients' disease progression and viral clearance require further investigation regarding HCQ treatment.
Purpose of the Study:
- To analyze the efficacy of hydroxychloroquine (HCQ) plus standard of care (SOC) versus SOC alone in reducing disease progression in mild COVID-19.
- To evaluate the impact of HCQ on viral clearance, measured by PCR negativity at days 7 and 14.
Main Methods:
- A single-center, open-label randomized controlled trial was conducted with 500 mild COVID-19 patients.
- Patients were assigned to either HCQ plus SOC (n=349) or SOC alone (n=151).
- Primary outcome was disease progression; secondary outcomes included PCR negativity on days 7 and 14.
Main Results:
- No significant difference in disease progression was observed between the HCQ group (3.15%) and the control group (3.3%) (p=0.940).
- PCR negativity on day 7 was significantly higher in the HCQ group (52.1%) compared to the control group (35.8%) (p=0.001).
- No significant differences were found in PCR negativity on day 14 (p=0.508) or consecutive PCR negativity on days 7 and 14 (p=0.321).
Conclusions:
- Adding hydroxychloroquine to standard care for mild COVID-19 does not prevent disease progression.
- Hydroxychloroquine does not significantly aid in early or sustained viral clearance in mild COVID-19 patients.
- The study suggests limited benefit of HCQ in the management of mild COVID-19 cases.
Abstract:
Background Hydroxychloroquine (HCQ) has been considered for the treatment of coronavirus disease 2019 (COVID-19), but data on its efficacy are conflicting. We analyzed the efficacy of HCQ along with standard of care (SOC) treatment, compared with SOC alone, in reducing disease progression in mild COVID-19. Methods A single-center open-label randomized controlled trial was conducted from April 10 to May 31, 2020 at Pak Emirates Military Hospital, Rawalpindi. Five hundred patients of both genders between the ages of 18 and 80 years with mild COVID-19 were enrolled in the study. A total of 349 patients were assigned to the intervention group (standard dose of HCQ plus SOC) and 151 patients were assigned to SOC only. The primary outcome was progression of disease while secondary outcome was polymerase chain reaction (PCR) negativity on days 7 and 14. The results were analyzed on Statistical Package for Social Sciences (SPSS; IBM Corp., Armonk, NY) version 23. A p-value <0.05 was considered significant. Results The median age of the intervention group was 34 ± 11.778 years and control group was 34 ± 9.813 years. Disease progressed in 16 patients, 11 (3.15%) of which were in the intervention group and 5 (3.3%) in the control group (p-value = 0.940). PCR negative cases in intervention and control groups on day 7 were 182 (52.1%) and 54 (35.8%), respectively (p-value = 0.001); and on day 14 were 244 (69.9%) and 110 (72.9%), respectively (p-value = 0.508). Consecutive PCR negativity on days 7 and 14 was observed in 240 (68.8%) patients in the intervention group compared to 106 (70.2%) in the control group (p-value = 0.321). Conclusion The addition of HCQ to SOC in hospitalized mild COVID-19 patients neither stops disease progression nor helps in early and sustained viral clearance.
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