Publication Boulware DR, N Engl J Med, 2020
Funding: Private ()
Multicenter / USA, Canada |
Follow-up duration (days): 90
|Inclusion criteria||Exposure to a COVID-19 within 4 days, either as: |
Healthcare worker, or
Household contact, or
Individual with COVID-19 disease confirmed by PCR+ or by compatible symptoms with exposure to known PCR+ case with <=4 days of symptoms.
Age >=18 years of age
Provision of Informed Consent
Allergy to chloroquine or hydroxychloroquine
Prior retinal eye disease
Concurrent malignancy requiring chemotherapy
Known Chronic Kidney disease, Stage 4 or 5 or dialysis.
Known glucose-6 phosphate dehydrogenase (G-6-PD)deficiency.
Weight <40 kg
Hydroxychloroquine (BDS Day1 then OD for 4 days)
Duration : 5 days
Placebo (BDS Day1 then OD for 4 days)
Duration : 5 days
821 participants (n1=407 / n2= 414)
|Characteristics of participants|
Mean age : NR
|In the register|
Primary Outcome Measures :1) Incidence of COVID19 Disease among those who are asymptomatic at baseline [Time Frame: 14 days] Number of participants at 14 days post enrollment with active COVID19 disease.2) Overall change in disease severity over 14 days among those who are symptomatic at baseline [Time Frame: 14 days] Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
|In the report|
symptomatic illness confirmed by a positive molecular assay or, if testing was unavailable, Covid-19? related symptoms.
Yes. In English
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||The trial was conducted online. The sample size was modified at an interim analysis and recruitment stopped at the next due to futility. The baseline characteristics of the randomized population are not representative of the "typical at risk/elderly/advanced chronic illness population). Although blinded with placebo folate control arm, the outome of syptomatic second cases and adverse events are participant reported very non specifically. Difference between the n randomized and the n analyzed.|