6/28/23, 12:19 AM COVID-19 PEP Pathway Feedback Search Clinical Topics Home Studies COVID 19 PEP COVID 19 PEP Disease COVID 19 infection Trial question What is the role of hydroxychloroquine as postexposure prophylaxis for COVID-19? Study design Multi-center Double blinded RCT Population Characteristics of study participants 52.0% female N = 821 48.0% male 821 patients (424 female, 397 male) Inclusion criteria: adults who had household or occupational exposure to someone with confirmed COVID-19 at a distance of < 6 feet for > 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure) Key exclusion criteria: age < 18 years, current hospitalization, allergy to hydroxychloroquine, retinal eye disease, known glucose-6 phosphate dehydrogenase deficiency, known CKD, structural or ischemic heart disease, personal or family history of prolonged QT syndrome Interventions N=414 hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days for a total course of 5 days) N=407 placebo (matching folate tablet in an identical regimen) Primary outcome https://web.pathway.md/studies/recaaUgd9TswfVq94 1/2 6/28/23, 12:19 AM COVID-19 PEP Pathway Incidence of either laboratory-confirmed coronavirus disease 2019 or illness compatible with coronavirus disease 2019 within 14 days 14.3 % 14.3 11.8 10.7 % 7.2 % 3.6 % No significant difference 0.0 % Hydroxychloroquine Placebo No significant difference in the incidence of either laboratory-confirmed COVID-19 or illness compatible with COVID-19 within 14 days (11.8% vs. 14.3%; ARD -2.4, 95% CI -7 to 2.2) Secondary outcomes No significant difference in all new symptoms (13.8% vs. 14.5%; ARD -0.7, 95% CI -7.05 to 5.65) Safety outcomes No significant differences in neurologic reaction (dizziness, irritability, vertigo), headache, skin reaction, fatigue, allergic reaction, dry mouth, or taste change. Significant differences in side-effects (40.1% vs. 16.8%), nausea or upset stomach (22.9% vs. 7.7%), gastrointestinal symptoms (23.2% vs. 4.3%). Conclusion In adults who had household or occupational exposure to someone with confirmed COVID-19 at a distance of < 6 feet for > 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure), hydroxychloroquine was not superior to placebo with respect to the incidence of either laboratory-confirmed COVID-19 or illness compatible with COVID-19 within 14 days. Reference David R Boulware, Matthew F Pullen, Ananta S Bangdiwala et al. A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19. N Engl J Med. 2020 Aug 6;383(6):517-525. Open reference URL https://web.pathway.md/studies/recaaUgd9TswfVq94 2/2