Abstract: International Journal of Infectious Diseases 102 (2021) 110–114 Contents lists available at ScienceDirect International Journal of Infectious Diseases journal homepage: www.elsevier.com/locate/ijid Hydroxychloroquine safety outcome with an approved therapeutic protocol for COVID-19 outpatients in Saudi Arabia Abdulrhman Mohanaa,* , Tarek Sulaimanb , Nagla Mahmoudc , Mustafa Hassaneinc, Amel Alfaific , Eissa Alenazic , Nashwa Radwanc, Nasser AlKhalifahb , Ehab Elkadyc , Abdullah Almohaizeied, Fouad AboGazalahc , Khaled AlabdulKareemc , Fahad AlGhofailib , Hani Jokhdare , Fahad Alrabiahd a Saudi Centre for Disease Prevention and Control, 70 SCDC Building, Al Aarid, King Abdulaziz Rd, Riyadh 13354, Saudi Arabia King Fahad Medical City, 59046 Riyadh 11525, Saudi Arabia c Assisting Deputyship for Primary Health Care, Ministry of Health, 11176 Riyadh, Saudi Arabia d King Faisal Specialist Hospital and Research Centre, Zahrawi St, Al Maath, Al Maazer, Riyadh 12713, Saudi Arabia e Deputyship of Public Health, Ministry of Health, 11176 Riyadh, Saudi Arabia b A R T I C L E I N F O A B S T R A C T Article history: Received 20 August 2020 Received in revised form 7 October 2020 Accepted 10 October 2020 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. © 2020 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-ncnd/4.0/). Keywords: Hydroxychloroquine COVID-19 Fever clinics Outpatient setting Safety outcome Infectious disease Background COVID-19 has rapidly emerged as a pandemic viral infection that has caused significant morbidity and death worldwide. Global * Corresponding author. E-mail addresses: abinmohana@gmail.com, aimohana@moh.gov.sa (A. Mohana), dr.tarek.sulaiman@gmail.com (T. Sulaiman), neelfadil@moh.gov.sa (N. Mahmoud), mustafasm@moh.gov.sa (M. Hassanein), amhalfaifi@moh.gov.sa (A. Alfaifi), ealali@moh.gov.sa (E. Alenazi),..