Hydroxychloroquine safety outcome with an approved therapeutic protocol for COVID-19 outpatients in Saudi Arabia

Abstract

Background: Global health has been challenged by the COVID-19 pandemic since late 2019. Multiple approaches have been applied to relieve pressure on and support existing healthcare. The Saudi Arabian Ministry of Health (MOH) launched an initiative to support the national healthcare system. Since 5 June 2020, 238 outpatient fever clinics have been established nationwide. This study aimed to assess the safety outcome and reported adverse events from hydroxychloroquine use among suspected COVID-19 patients. Methods: The cross-sectional study included 2733 patients subjected to the MOH treatment protocol (hydroxychloroquine) and followed up for 3–7 days after initiation. Data were collected through an electronic link and cross-checked with the national database (Health Electronic Surveillance Network) and reports from the MOH Morbidity and Mortality Committee. Results: Two hundred and forty patients (8.8%) discontinued treatment because of side effects (4.1%) and non-clinical reasons (4.7%). Adverse effects were reported among 6.7% of all participants, including mainly cardiovascular symptoms (2.5%; 0.15% with corrected QT prolongation) and gastrointestinal symptoms (2.4%). No intensive care unit admission or death was reported among these patients. Conclusion: Our results show that hydroxychloroquine use for COVID-19 patients with mild to moderate symptoms in an outpatient setting with the recommended protocol and inclusion/exclusion criteria is safe, is highly tolerable and has minimal side effects.