Clinical trial NCT04354597: Hydroxychloroquine and Azithromycin as Prophylaxis for Healthcare Workers Dealing With COVID19 Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
Prophylaxis
Hydroxychloroquine
Azithromycin
Lead sponsor: King Hussein Cancer Center
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects who are enrolled in the study will be randomly assigned to any of the study arms, A or B.

Study Arm A (HCQ \& AZ)

Study Arm B (No treatment)
Primary purpose: PREVENTION

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.

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-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.

Primary outcomes:
measure: Effect of HCQ and AZ in preventing infection with COVID-19 among healthcare workers working with COVID-19 patients
timeFrame: 4 Months
Secondary outcomes:
measure: Safety of HCQ and AZ
timeFrame: 4 Months
measure: Oxygen requirement
timeFrame: 4 Months
measure: ICU admission
timeFrame: 4 Months
measure: Mortality rate
timeFrame: 4 Months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: King Hussein Cancer Center
Study officials:
References: