Official Title
Will Hydroxychloroquine Impede or Prevent COVID-19: WHIP COVID-19 Study
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 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.

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 in a 1:1:1 blinded comparison of daily HCQ, weekly HCQ, or placebo. A fourth non-randomized comparator group of HCW, NHW, DDOT bus drivers, and FR who are currently on standard HCQ therapy will be recruited to assess the impact of weightbased daily dosing of HCQ as compared to the randomized arms.

Eligible participants who are asymptomatic for pre-specified signs and symptoms suggestive of COVID-19 infection will have a whole blood specimen obtained at study entry.

Participants will be provided with weekly dosing of hydroxychloroquine (HCQ) 400mg po q weekly, daily dosing of HCQ 200mg po q daily following a loading dose of 400mg day 1, or placebo. Participants will receive monitoring at each study week visit to assess for the development of COVID-19 related symptoms, COVID-19 clinical disease, and medication side effects. At week 8 or if diagnosed positive, participants will provide additional samples of whole blood and complete the final study questionnaire.

Data including demographic, clinical results, work duties, location of main work area and possible exposures in the community will be collected through questionnaires and EMR review. Disease-specific, immunologic, and other serologic marker data will be obtained from stored samples.

Recruiting
COVID-19
Coronavirus
Coronavirus Infections
SARS-CoV 2

Drug: Hydroxychloroquine - Daily Dosing
The daily hydroxychloroquine treatment arm will receive a 200 mg oral dose daily following day 1 dose of 400 mg orally once. This dose represents approximately half the standard weight-based dosing recommended for management of autoimmune diseases and therefore less likely to produce side effects than standard of care.
All treatment groups will receive placebo pills to have the patients take 2 pills a day.
Study Drug - Daily Dose
Other Name: Study Drug - Daily
Other Name: Daily Oral Dosing

Drug: Hydroxychloroquine - Weekly Dosing
The once weekly randomized treatment arm will receive the proposed dose of hydroxychloroquine for prophylaxis of malaria is 6.5 mg/kg per dose (maximum of 400 mg per dose) administered orally weekly on the same day of each week. This is based on the recommended dose for prophylaxis of malaria
All treatment groups will receive placebo pills to have the patients take 2 pills a day.
Study Drug - Weekly Dose
Other Name: Weekly Oral Dosing

Other: Placebo oral tablet
Participants randomized to this arm will be provided with daily dosing of oral placebo to have the patients take 2 pills a day..
Participants will receive a monitoring phone call at 4 weeks post study entry to monitor for COVID-19 symptoms and medication side effects. At week 8, participants will provide additional samples of whole blood.
Additional studies will include serology, inflammatory and other disease associated markers. Clinical data and location of main work area will be collected.
Placebo
Other Name: Placebo

Diagnostic Test: Monitoring Visit - Baseline
Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.
Non-Randomized Active Comparator
Placebo
Study Drug - Daily Dose
Study Drug - Weekly Dose
Other Name: Baseline Monitoring Visit

Diagnostic Test: Monitoring Visit - Week 4
Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.
Non-Randomized Active Comparator
Placebo
Study Drug - Daily Dose
Study Drug - Weekly Dose
Other Name: Week 4 - Monitoring Visit

Diagnostic Test: Monitoring Visit - Week 8
Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.
Non-Randomized Active Comparator
Placebo
Study Drug - Daily Dose
Study Drug - Weekly Dose
Other Name: Week 8 - Monitoring Visit

Other: Weekly Assessment
Participants will be asked to contact the study team if COVID-19 infection is established at any time during the study. For study weeks 1,2,3,5,6 &7, Participants will receive a monitoring questionnaire to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects. These monitoring visits will be done by telephone and/or electronic encounters (virtual visits, email), whichever method the patient prefers to encourage adherence to the monitoring.
Non-Randomized Active Comparator
Placebo
Study Drug - Daily Dose
Study Drug - Weekly Dose
Other Name: Monitoring Call

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 75 Years
Countries
United States
Locations

Henry Ford Hospital
Detroit, Michigan, 48202

Recruiting

Investigator: Dee Dee Wang, MD
Contact: 313-574-2651
whipcovid19@hfhs.org


Investigator: John McKinnon, MD
Contact: 313-574-2651
whipcovid19@hfhs.org

Detroit Department of Transportation (DDOT)
Detroit, Michigan, 48226

Recruiting

Detroit Fire Department & Detroit EMS
Detroit, Michigan, 48226

Recruiting

Detroit Police Department
Detroit, Michigan, 48226

Recruiting

Contacts

Dee Dee Wang, MD
313-574-2651
whipcovid19@hfhs.org

Laurie Nightengale, MD
313-574-2651
whipcovid19@hfhs.org

William W O'Neill, MD
Principal Investigator
Henry Ford Health System

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Dee Dee Wang, MD
Study Director
Henry Ford Health System

Henry Ford Health System
NCT Number
Keywords
Covid-19
Coronavirus
Healthcare Workers
SARS-CoV 2
First Responders
Emergency Medical Technicians
Paramedics
Firefighters
Police Officers
Detroit
Michigan
Henry Ford Hospital
MeSH Terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Hydroxychloroquine