Status:
UNKNOWN
HEalth Care Worker pROphylaxis Against COVID-19: The HERO Trial
Lead Sponsor:
GeoSentinel Foundation
Conditions:
Prophylaxis
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 t...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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).
- Age ≥18 years.
- Ability to communicate with study staff in English
Exclusion
- Known hypersensitivity/allergy to hydroxychloroquine or to 4-aminoquinoline compounds.
- Current use of hydroxychloroquine for the treatment of a medical condition.
- 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.
- Known pre-existing retinopathy of the eye.
- 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).
- 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.
Key Trial Info
Start Date :
April 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 24 2020
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT04352946
Start Date
April 24 2020
End Date
August 24 2020
Last Update
April 22 2020
Active Locations (1)
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1
The New York Center for Travel and Tropical Medicine
New York, New York, United States, 10022