COVID-19 PEP
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
48.0% male
N = 821
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
Incidence of either laboratory-confirmed coronavirus disease 2019 or illness compatible with coronavirus disease 2019 within 14 days
11.8
14.3
14.3 %
10.7 %
7.2 %
3.6 %
0.0 %
Hydroxychloroquine
Placebo
No significant
difference ↔
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
Borderline significant increase in hospitalization (0.2% vs. 0.2%; )
Significant increase in symptoms compatible with COVID-19 (11.6% vs. 13.5%; )
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.
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