Will Hydroxychloroquine Impede or Prevent COVID-19

• Status: Terminated
• Trial end date: 2020-12-15
• Target enrollment: 0
• Participant gender: All

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 Department of Transportation bus drivers (DDOT) in SE, Michigan, can prevent the acquisition, symptoms and clinical COVID-19 infection

The primary objective of this study is to determine whether the use of daily or weekly oral hydroxychloroquine (HCQ) therapy will prevent SARS-CoV-2 infection and COVID-19 viremia and clinical COVID-19 infection healthcare workers (HCW) and first responders (FR) (EMS, Fire, Police, bus drivers) in Southeast Michigan.

Preventing COVID-19 transmission to HCW, FR, and Detroit Department of Transportation (DDOT) bus drivers is a critical step in preserving the health care and first responder force, the prevention of COVID-19 transmission in health care facilities, with the potential to preserve thousands of lives in addition to sustaining health care systems and civil services both nationally and globally. If efficacious, further studies on the use of hydroxychloroquine to prevent COVID-19 in the general population could be undertaken, with a potential impact on hundreds of thousands of lives.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Henry Ford Health System
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

1. Participant is willing and able to provide informed consent.

2. Participant is 18-75 years of age.

3. 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.

4. Participant is willing to provide blood samples for the study.

5. Subject agrees to all aspects of the study.

6. 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 Criteria:

1. Does not meet inclusion criteria.

2. Participant unable or unwilling to provide informed consent.

3. Participant has any of the symptoms above or screens positive for possible COVID-19 disease.

4. Participant is currently enrolled in a study to evaluate an investigational drug.

5. Vulnerable populations deemed inappropriate for study by the site Principal Investigator.

6. 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).

7. The participant is a woman of childbearing age whose pregnancy status is unknown and is not willing to use 2 methods of contraception.

8. The participant is pregnant or nursing.

9. The participant was diagnosed with retinopathy prior to study entry.

10. The participant has a diagnosis of porphyria prior to study entry.

11. The participant has renal failure with a creatinine clearance of <10 ml/min, pre-dialysis or requiring dialysis.

12. The Participant has a family history of Sudden Cardiac Death.

13. The participant is currently on diuretic therapy.

14. The participant has a history of known Prolonged QT Syndrome.

15. 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).