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A Cluster-Randomized Trial of Hydroxychloroquine as Prevention of Covid-19 Transmission and Disease

2020; Cold Spring Harbor Laboratory; Linguagem: Inglês

10.1101/2020.07.20.20157651

Natàlia Casamitjana, María Ubals, Marc Corbacho-Monné, Andrea Alemany, Clara Suñer, Cristian Tebé, Aurelio Tobı́as, Judith Peñafiel, Ester Ballana, Carla A. Pérez, Pol Admella, Nuria Martí, Pep Laporte, Jordi Mitjà, Mireia Clua, Laia Bertran, Maria Sarquella, Sergi Gavilán, Jordi Ara, Josep M. Argimón, Gabriel Cuatrecasas, M. Paz Cañadas, Aleix Elizalde‐Torrent, Robert Fabregat, Magı́ Farré, Anna Forcada, Gemma Flores‐Mateo, Cristina López, Esteve Muntada, Núria Nadal, Silvia Narejos, Aroa N Gil-Ortega, Núria Prat, Jordi Puig, Carles Quiñones, Ferran Ramírez-Viaplana, Juliana Reyes- Urueña, Eva Riveira‐Muñoz, Lı́dia Ruiz, Sergi Sanz, Alexis Sentís, Alba Sierra, César Velasco, Rosa Maria Vivanco‐Hidalgo, Juani Zamora, Jordi Casabona, Martí Vall-Mayans, Camila González-Beiras, Bonaventura Clotet,

Long-Term Effects of COVID-19

ABSTRACT Background Current strategies for preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections are limited to non-pharmacological interventions. Hydroxychloroquine (HCQ) has been proposed as a postexposure therapy to prevent Coronavirus disease 2019 (Covid-19) but definitive evidence is lacking. Methods We conducted an open-label, cluster-randomized trial including asymptomatic contacts exposed to a PCR-positive Covid-19 case in Catalonia, Spain. Clusters were randomized to receive no specific therapy (control arm) or HCQ 800mg once, followed by 400mg daily for 6 days (intervention arm). The primary outcome was PCR-confirmed symptomatic Covid-19 within 14 days. The secondary outcome was SARS-CoV-2 infection, either symptomatically compatible or a PCR-positive result regardless of symptoms. Adverse events (AEs) were assessed up to 28 days. Results The analysis included 2,314 healthy contacts of 672 Covid-19 index cases identified between Mar 17 and Apr 28, 2020. A total of 1,198 were randomly allocated to usual care and 1,116 to HCQ therapy. There was no significant difference in the primary outcome of PCR-confirmed, symptomatic Covid-19 disease (6.2% usual care vs. 5.7% HCQ; risk ratio 0.89 [95% confidence interval 0.54-1.46]), nor evidence of beneficial effects on prevention of SARS-CoV-2 transmission (17.8% usual care vs. 18.7% HCQ). The incidence of AEs was higher in the intervention arm than in the control arm (5.9% usual care vs 51.6% HCQ), but no treatment-related serious AEs were reported. Conclusions Postexposure therapy with HCQ did not prevent SARS-CoV-2 disease and infection in healthy individuals exposed to a PCR-positive case. Our findings do not support HCQ as postexposure prophylaxis for Covid-19. ClinicalTrials.gov registration number NCT04304053