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.
Drug: Hydroxychloroquine Pre-Exposure Prophylaxis
HCQ PreP 400mg daily
Other Name: Array
Drug: Placebo oral tablet
Placebo tablets 400mg daily
Other Name: Placebo
Inclusion Criteria:
1. Health care worker (HCW) at the hospital who work on a "full time" basis during the
study period. For the purposes of the study, "health care workers" are physicians,
nurses, nurse practitioners, physician assistants, respiratory therapists, X-ray
technicians, social workers and support staff (including but not limited to
house-keeping, and porters).
2. Age ≥18 years.
3. Ability to communicate with study staff in English
Exclusion Criteria:
1. Known hypersensitivity/allergy to hydroxychloroquine or to 4-aminoquinoline compounds.
2. Current use of hydroxychloroquine for the treatment of a medical condition.
3. Known prolonged QT syndrome, or concomitant medications which simultaneously may
prolong the QTC that cannot be temporarily suspended/replaced. These are including but
not limited to Class IA, IC and III antiarrhythmics; certain antidepressants,
antipsychotics, and anti-infectives; domperidone; 5-hydroxytryptamine (5-HT)3 receptor
antagonists; kinase inhibitors; histone deacetylase inhibitors beta-2 adrenoceptor
agonists.
4. Known pre-existing retinopathy of the eye.
5. Disclosure of self-administered use of hydroxychloroquine or chloroquine currently
under investigation <4 weeks prior to study. This window is intended to account for
the drug half-life of HCQ (21 days).
6. Baseline symptom of COVID-19 disease at enrollment and baseline viral detection
specimen positive for SARS-COV-2. All participants with COVID-19 symptoms at
enrollment will be directed to have confirmatory testing (within the department or
occupational health as per the site guidelines). Participants who are negative for
SARS-COV-2 will be redirected to enrollment procedures, those testing positive will be
excluded.
The New York Center for Travel and Tropical Medicine
New York, New York, United States
Investigator: Bradley A Connor, MD
Contact: 212-988-2800
bconnor1@gmail.com
Investigator:
Bradley A Connor, MD
9172138998
bconnor1@gmail.com
Marina Rogova, RN
8434247542
marina.rogova@connormd.com
Bradley A Connor, MD, Principal Investigator
Dr. Bradley A. Connor