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Hydroxychloroquine for Early Treatment of Adults With Mild Coronavirus Disease 2019: A Randomized, Controlled Trial
Oriol Mitjà1,2,3, Marc Corbacho-Monné1,4, Maria Ubals2,4
1Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.
Insights
Early hydroxychloroquine (HCQ) treatment did not show benefits for mild COVID-19 outpatients. This study found no significant reduction in viral load, hospitalization, or symptom duration compared to usual care.
Area of Science:
- Infectious Diseases
- Pharmacology
- Clinical Trials
Background:
- Coronavirus disease 2019 (COVID-19) presented a significant global health challenge with limited effective treatments.
- Early therapeutic interventions were explored to mitigate disease severity and transmission.
Purpose of the Study:
- To evaluate the efficacy of early hydroxychloroquine (HCQ) treatment in outpatients diagnosed with COVID-19.
- To determine if HCQ reduces viral load, disease progression, and symptom duration.
Main Methods:
- A multicenter, open-label, randomized controlled trial was conducted in Spain.
- Patients with recent COVID-19 onset (<5 days) received either HCQ or usual care.
- Outcomes included viral load reduction, disease progression, symptom resolution, and adverse events.
Main Results:
- No significant difference in viral load reduction at day 3 or day 7 was observed between the HCQ and control groups.
- Hydroxychloroquine treatment did not reduce the risk of hospitalization or shorten symptom resolution time.
- No major adverse events were reported during the study period.
Conclusions:
- Early hydroxychloroquine treatment offers no discernible benefit over usual care for mild COVID-19 outpatient cases.
- Further research may be needed to explore other therapeutic avenues for COVID-19 management.
Background:
No effective treatments for coronavirus disease 2019 (COVID-19) exist. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be efficacious for outpatients with COVID-19.
Methods:
Multicenter open-label, randomized, controlled trial conducted in Catalonia, Spain, between 17 March and 26 May 2020. Patients recently diagnosed with <5-day of symptom onset were assigned to receive HCQ (800 mg on day 1 followed by 400 mg once daily for 6 days) or usual care. Outcomes were reduction of viral load in nasopharyngeal swabs up to 7 days after treatment start, disease progression up to 28 days, and time to complete resolution of symptoms. Adverse events were assessed up to 28 days.
Results:
A total of 293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm. The mean age was 41.6 years (SD, 12.6), mean viral load at baseline was 7.90 log10 copies/mL (SD, 1.82), and median time from symptom onset to randomization was 3 days. No differences were found in the mean reduction of viral load at day 3 (-1.41 vs -1.41 log10 copies/mL in the control and intervention arm, respectively) or at day 7 (-3.37 vs -3.44). Treatment did not reduce risk of hospitalization (7.1% control vs 5.9% intervention) nor shorten the time to complete resolution of symptoms (12 days, control vs 10 days, intervention). No relevant adverse events were reported.
Conclusions:
In patients with mild COVID-19, no benefit was observed with HCQ beyond the usual care.
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