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Hydroxychloroquine Safety Outcome within Approved Therapeutic Protocol for COVID-19 Outpatients in Saudi Arabia

Mohana et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2020.10.031 (date from preprint)
Oct 2020  
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HCQ for COVID-19
1st treatment shown to reduce risk in March 2020
*, now known with p < 0.00000000001 from 421 studies, recognized in 42 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
3,800+ studies for 60+ treatments.
Safety study of 2,733 patients in Saudi Arabia showing HCQ in mild to moderate cases in an outpatient setting, within the protocol recommendation and inclusion/exclusion criteria, is safe, highly tolerable, and has minimal side effects. No ICU admission or deaths were reported.
Mohana et al., 17 Oct 2020, peer-reviewed, 15 authors.
This PaperHCQAll
Hydroxychloroquine Safety Outcome within Approved Therapeutic Protocol for COVID-19 Outpatients in Saudi Arabia
Abdulrhman Mohana, Tarek Sulaiman, Nagla Mahmoud, Mustafa Hassanein, Amel Alfaifi, Eissa Alenazi, Nashwa Radwan, Nasser Alkhalifah, Ehab Elkady, Abdullah Almohaizeie, Fouad Abogazalah, Khaled Alabdulkareem, Fahad Alghofaili, Hani Jokdar, Fahad Alrabiah
International Journal of Infectious Diseases, doi:10.1016/j.ijid.2020.10.031
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.
Conflict of interest None declared. Ethics approvals This research was approved and followed closely by the Ministry of Health Institutional Review Board (log number 20-129M). Informed consent was obtained, by the treating physician, from the participants after explanation of the study. Those who refused to participate in the study were excluded and continued with standard supportive care. All information collected was kept confidential and will not be used for purposes other than the study.
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