A Multicenter, Open-label, Pilot Study on Using Hydroxychloroquine (HCQ) and Azithromycin (AZ) Prophylaxis for Healthcare Workers With a Potential Risk of Exposure to COVID-19 Patients
Overview
- Phase
- Not Applicable
- Intervention
- HCQ & AZ
- Conditions
- COVID-19
- Sponsor
- King Hussein Cancer Center
- Locations
- 1
- Primary Endpoint
- Effect of HCQ and AZ in preventing infection with COVID-19 among healthcare workers working with COVID-19 patients
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
The main objective of this study is to assess the efficacy of the combination hydroxychloroquine and Azithromycin (HCQ and AZ) in reducing the infection risk among health care professionals in direct contact with COVID-19 patients.
Detailed Description
Exceptional efforts have been paid globally to apply the latest and most effective means of universal standard precautions throughout the settings facing COVID-19 crisis, and this is led by health care providers who are more vulnerable and have a higher risk of getting the infection (8.3% in Italy) and a higher rate of complications and mortality with some reports suggesting high mortality among these individuals. While several clinical trials are underway across the globe to examine the effect of chloroquine at the moment, the number of COVID-19 cases is still on the rise and health care workers are facing a very high risk of getting the infection. In this study, we aim to study prophylactic efficacy of the combination (HCQ and AZ) among health care professionals in a 16 weeks period.
Investigators
Iyad Sultan
Chairman- Department of Pediatrics, Pediatrics Administration
King Hussein Cancer Center
Eligibility Criteria
Inclusion Criteria
- •Medical doctors, Nurses and Respiratory therapists caring for COVID-19 patients in ER and ICU and dedicated COVID19 units.
- •Age between 18 and 70 years old.
- •Male or non-pregnant, non- lactating female.
- •Availability for follow up by phone.
- •Willing to participate and provide signed informed consent.
Exclusion Criteria
- •Subjects with a history of retinopathy, sickle cell disease or trait, psoriasis, or porphyria.
- •Subjects who take certain prescribed or over the counter (OTC) concomitant medication including ampicillin, cimetidine, digoxin, statins, cyclosporine, warfarin, fluconazole, within 2 weeks of dosing start, and during the duration of the study.
- •Current Symptoms of Fever, Cough, or Shortness of Breath.
- •PCR confirmed positive test of COVID-
- •Weight \< 40 kg.
- •Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at the screening.
- •Allergy to any of the study medications.
- •History of splenectomy.
- •Infection with hepatitis B or C viruses.
- •Chronic or active neurologic disease including seizure disorder and chronic migraine headaches.
Arms & Interventions
Study Arm A (HCQ & AZ)
Subjects will receive weekly HCQ 400mg X 1 Day PO and AZ 500mg PO X 3 Days; weekly for 16 weeks.
Intervention: HCQ & AZ
Outcomes
Primary Outcomes
Effect of HCQ and AZ in preventing infection with COVID-19 among healthcare workers working with COVID-19 patients
Time Frame: 4 Months
Compare the proportion of participants who have RT-PCR confirmed infection with SARS-CoV-2 in both arms during the study period, measured by negative PCR test for SARS COV-2 virus
Secondary Outcomes
- ICU admission(4 Months)
- Mortality rate(4 Months)
- Safety of HCQ and AZ(4 Months)
- Oxygen requirement(4 Months)