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

  1. Oriol MitjĂ 
  2. Maria Ubals
  3. Marc Corbacho-Monné
  4. Andrea Alemany
  5. Clara Suñer
  6. Cristian Tebe
  7. Aurelio Tobias
  8. Judith Peñafiel
  9. Ester Ballana
  10. Carla A. PĂ©rez
  11. Pol Admella
  12. Nuria Riera-MartĂ­
  13. Pep Laporte
  14. Jordi Mitja
  15. Mireia Clua
  16. Laia Bertran
  17. Maria Sarquella
  18. Sergi GavilĂĄn
  19. Jordi Ara
  20. Josep M Argimon
  21. Gabriel Cuatrecasas
  22. Paz Cañadas
  23. Aleix Elizalde-Torrent
  24. Robert Fabregat
  25. Magí Farré
  26. Anna Forcada
  27. Gemma Flores-Mateo
  28. Cristina LĂłpez
  29. Esteve Muntada
  30. NĂșria Nadal
  31. Silvia Narejos
  32. Aroa N Gil-Ortega
  33. Nuria Prat
  34. Jordi Puig
  35. Carles Quiñones
  36. Ferran RamĂ­rez-Viaplana
  37. Juliana Reyes- Urueña
  38. Eva Riveira-Muñoz
  39. Lidia Ruiz
  40. Sergi Sanz
  41. Alexis Sentis
  42. Alba Sierra
  43. CĂ©sar Velasco
  44. Rosa Maria Vivanco-Hidalgo
  45. Juani Zamora
  46. Jordi Casabona
  47. MartĂ­ Vall-Mayans
  48. Camila G-Beiras
  49. Bonaventura Clotet
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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.

<ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link> registration number

NCT04304053

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