COVID-19 Clinical Trial
Official title:
Protecting Health Care Workers From COVID-19 With Hydroxychloroquine Pre-exposure Prophylaxis: A Randomized, Placebo-controlled Trial
This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic. 374 health care workers will be randomized at a 1:1 allocation between the intervention and placebo arms and followed for 90 days. The cumulative incidence of COVID-19 infection in the intervention group will be compared to the cumulative incidence of COVID-19 in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk difference and 95% CI).
This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure
prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health
care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the
pandemic.
Secondary outcomes include 1) Adverse events; 2) Duration of symptomatic COVID-19 disease; 3)
Days hospitalized attributed to COVID-19; 4) Respiratory failure attributable to COVID-19
disease requiring i) non-invasive ventilation or ii) intubation/mechanical ventilation; 5)
Mortality attributed to COVID-19 disease, and; 6) Number of days unable to work attributed to
COVID-19. Laboratory markers within participants with confirmed COVID-19 will also be
explored.
A total of 374 HCW will be randomized using a fixed 1:1 allocation ratio with randomization
in permuted block of varying sizes from four to eight will be used to ensure equal allocation
to each group. The study population will be health care workers at the New York Presbyterian
Hospital - Cornell Campus and they will participate in the study for 90 days.
To determine if the intervention has been successful, the cumulative incidence of COVID-19
infection in the intervention group will be compared to the cumulative incidence of COVID-19
in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk
difference and 95% CI). Investigators will also calculate adjusted risk ratios and risk
differences including job class as a covariate and any other baseline clinical and
demographic characteristics that are not balanced between the treatment and placebo arms
using a log-binomial regression model.
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