Trial NCT04308668
Publication Boulware DR, N Engl J Med, 2020
Funding: Mixed (David Baszucki and Jan Ellison Baszucki; Alliance of Minnesota Chinese Organizations; Minnesota Chinese Chamber of Commerce; University of Minnesota)
| Methods | |
| RCT | |
| Location :
Multicenter / USA, Canada Follow-up duration (days): 14 | |
| 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 |
| Exclusion criteria | Younger than 18 years of age
Current hospitalization 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. Known Porphyria Weight <40 kg Persons with symptoms of Covid-19 or with PCR-proven SARS-CoV-2 infection |
| Interventions | |
| Treatment
Hydroxychloroquine (600 mg* OD) Duration : 5 days |
|
| Control
Placebo Duration : 5 days | |
| Participants | |
| Randomized 821 participants (n1=414 / n2= 407) | |
| Characteristics of participants N=821 Mean age : NR 397 males | |
| Primary outcome | |
| In the register 1) Incidence of COVID-19 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 | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | In addition to the published report, the trial registration, protocol and statistical plan analysis were used in data extraction and risk of bias assessment. 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 |