Hydroxychloroquine for Early Treatment of Adults with Mild Covid-19: A Randomized-Controlled Trial

Type Journal Article Author Oriol Mitjà Author Marc Corbacho-Monné Author Maria Ubals Author Cristian Tebe Author Judith Peñafiel Author Aurelio Tobias Author Ester Ballana Author Andrea Alemany Author Núria Riera-Martí Author Carla A. Pérez Author Clara Suñer Author Pep Laporte Author Pol Admella Author Jordi Mitjà Author Mireia Clua Author Laia Bertran Author Maria Sarquella Author Sergi Gavilán Author Jordi Ara Author Josep M. Argimon Author Jordi Casabona Author Gabriel Cuatrecasas Author Paz Cañadas Author Aleix Elizalde-Torrent Author Robert Fabregat Author Magí Farré Author Anna Forcada Author Gemma Flores-Mateo Author Esteve Muntada Author Núria Nadal Author Silvia Narejos Author Aroa N. Gil-Ortega Author Nuria Prat Author Jordi Puig Author Carles Quiñones Author Juliana Reyes-Ureña Author Ferran Ramírez-Viaplana Author Lidia Ruiz Author Eva Riveira-Muñoz Author Alba Sierra Author César Velasco Author Rosa Maria Vivanco-Hidalgo Author Alexis Sentís Author Camila G-Beiras Author Bonaventura Clotet Author Martí Vall-Mayans Author BCN PEP-CoV-2 RESEARCH Group URL https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1009/5872589 Publication Clinical Infectious Diseases Date 16/07/2020 Journal Abbr Clin Infect Dis DOI 10.1093/cid/ciaa1009 Library Catalog academic.oup.com Language en Abstract BACKGROUND No therapeutics have yet been proven effective for the treatment of mild-illness caused by SARS-CoV-2. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be more efficacious than no-treatment for outpatients with mild Covid-19. METHODS We conducted a multicenter, open label, randomized controlled trial in Catalonia (Spain) between March 17, and May 26, 2020. Eligible Covid-19 cases were non-hospitalized adult patients with recently confirmed SARS-CoV-2 infection and less than five days of symptoms. Patients were assigned to receive HCQ (800 mg on day 1, followed by 400 mg once daily for 6 days) or no antiviral treatment (not-placebo controlled). Study outcomes were the reduction of viral RNA load in nasopharyngeal swabs up to 7 days after treatment start, patient disease progression using the WHO scale 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 (SD 1.82) Log10 copies/mL, and median time from symptom onset to randomization was 3 days. No significant 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; difference 0.01 [95% CI -0.28;0.29]) or at day 7 (-3.37 vs. -3.44; d –0.07 [-0.44;0.29]). This treatment regimen did not reduce risk of hospitalization (7.1%, control vs. 5.9%, intervention; RR 0.75 [0.32;1.77]) nor shortened the time to complete resolution of symptoms (12 days, control vs. 10 days, intervention; p = 0.38). No relevant treatment-related AEs were reported. Short Title Hydroxychloroquine for Early Treatment of Adults with Mild Covid-19