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.
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.
Drug: HCQ & AZ
Subjects will receive weekly HCQ 400mg PO and AZ PO 500mg X 3 Days; weekly for 16 weeks.
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-19.
- 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.
- Any abnormal baseline laboratory screening tests listed below
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)above twice the
upper limit of normal for the reference lab.
- Creatinine above the normal range.
- Hemoglobin for males <12.5 g/dl and females <10.5 g/dl.
- Platelet count of <150 X 103/L.
- Total white blood cell (WBC) count out of normal range Note: If screening lab
values are out of the normal range but are expected to be temporary (e.g. due to
dehydration), they may be re-assessed one more time at the discretion of the
investigator.
- An abnormal baseline screening ECG suggestive of cardiac disease as determined by a
clinical investigator. QTcF of >450 msec for males and >470 msec for females.
- Any other significant finding that based on the judgment of the PI would increase the
risk of having an adverse outcome from participating in this study
- Subjects known to have a mental illness
- Subjects who have Skin disorders (including rash, dermatitis, and psoriasis)
- Hematological disease.
- Cardiovascular disease.
- G6PD deficiency.
- Lactose intolerance.
King Hussein Cancer Center
Amman, Jordan