COVID-19 Clinical Trial
— HEROOfficial 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).
Status | Not yet recruiting |
Enrollment | 374 |
Est. completion date | August 24, 2020 |
Est. primary completion date | June 24, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | The New York Center for Travel and Tropical Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
GeoSentinel Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Proportion of HCW with plasma able to neutralize SARS-CoV-2 virus | Proportion of participants with plasma able to neutralize SARS-CoV-2 virus (plaque reduction neutralization test) in vitro. | 90 days | |
Other | Number of participants with severity markers of host immune and endothelial activation | Number of participants with severity markers of host immune and endothelial activation measured at clinical presentation and their ability to predict severity and outcome. | 90 days | |
Primary | Cumulative Incidence of COVID-19 Infection | Incidence of symptomatic and asymptomatic COVID-19 infection in health care workers | 90 days | |
Secondary | Adverse events incidence | Incidence of reported and grade of adverse events | 90 days | |
Secondary | Duration of symptomatic COVID-19 disease | Duration in days of symptomatic COVID-19 disease in HCW who had disease | 90 days | |
Secondary | Days hospitalized attributed to COVID-19 | Duration in days of hospitalization attributed to COVID-19 disease in HCW who had disease | 90 days | |
Secondary | Number or respiratory failure attributable to COVID-19 disease | Number of HCW with respiratory failure attributable to COVID-19 disease requiring i) non-invasive ventilation or ii) intubation/mechanical ventilation in HCW who developed disease | 90 days | |
Secondary | Mortality Incidence | Cumulative Incidence of Mortality attributed to COVID-19 disease in HCW who developed disease | 90 days | |
Secondary | Days of work lost | Number of days unable to work attributed to COVID-19 in HCW who developed disease | 90 days |
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