Status:
TERMINATED
Will Hydroxychloroquine Impede or Prevent COVID-19
Lead Sponsor:
Henry Ford Health System
Conditions:
COVID-19
Coronavirus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a prospective, multi-site study designed to evaluate whether the use of hydroxychloroquine in healthcare workers (HCW), Nursing Home Workers (NHW), first responders (FR), and Detroit Departmen...
Detailed Description
The study will randomize a total of 3,000 HCW, NHW, FR and DDOT bus drivers within Henry Ford Hospital System, the Detroit COVID Consortium in Southeast, Michigan. The participants will be randomized ...
Eligibility Criteria
Inclusion
- Participant is willing and able to provide informed consent.
- Participant is 18-75 years of age.
- Participant does not have symptoms of respiratory infection, including cough, fevers (temperature \>38.0C), difficulty breathing, shortness of breath, chest pains, malaise, myalgia, headaches, nausea or vomiting, or other symptoms associated with COVID-19.
- Participant is willing to provide blood samples for the study.
- Subject agrees to all aspects of the study.
- The participant has no known allergies or contraindications (as stated in the consent form) to the use of hydroxychloroquine (HCQ) as noted in the exclusion criteria and Pharmacy sections.
Exclusion
- Does not meet inclusion criteria.
- Participant unable or unwilling to provide informed consent.
- Participant has any of the symptoms above or screens positive for possible COVID-19 disease.
- Participant is currently enrolled in a study to evaluate an investigational drug.
- Vulnerable populations deemed inappropriate for study by the site Principal Investigator.
- The participant has a known allergy/hypersensitivity or has a medication or co-morbidity (including history of gastric bypass, epilepsy, cardiovascular disease or renal failure) that prevents the use of HCQ (see pharmacy section).
- The participant is a woman of childbearing age whose pregnancy status is unknown and is not willing to use 2 methods of contraception.
- The participant is pregnant or nursing.
- The participant was diagnosed with retinopathy prior to study entry.
- The participant has a diagnosis of porphyria prior to study entry.
- The participant has renal failure with a creatinine clearance of \<10 ml/min, pre-dialysis or requiring dialysis.
- The Participant has a family history of Sudden Cardiac Death.
- The participant is currently on diuretic therapy.
- The participant has a history of known Prolonged QT Syndrome.
- The participant is already taking any of the following medications: Abiraterone acetate, Agalsidase, Amodiaquine, Azithromycin, Conivaptan, Dabrafenib, Dacomitinib, Dapsone (Systemic), Digoxin, Enzalutamide, Fusidic Acid (Systemic), Idelalisib, Lanthanum, Lumefantrine, Mefloquine, Mifepristone, Mitotane, Pimozide, QT-prolonging Agents, Stiripentol).
Key Trial Info
Start Date :
April 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT04341441
Start Date
April 7 2020
End Date
December 15 2020
Last Update
June 21 2022
Active Locations (1)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202