Hydroxychloroquine and Azithromycin as Prophylaxis for Healthcare Workers Dealing With COVID19 Patients

NCT ID: NCT04354597

Last Updated: 2021-10-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2020-10-15

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HCQ & AZ

Intervention Type: DRUG

Subjects will receive weekly HCQ 400mg PO and AZ PO 500mg X 3 Days; weekly for 16 weeks.

Study Arm B (No treatment)

Subjects will receive no treatment in this group and will be serving as control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HCQ & AZ

Subjects will receive weekly HCQ 400mg PO and AZ PO 500mg X 3 Days; weekly for 16 weeks.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Hussein Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Iyad Sultan

Chairman- Department of Pediatrics, Pediatrics Administration

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King Hussein Cancer Center

Amman, , Jordan

Countries

Jordan

Other Identifiers

20 KHCC 67

Identifier Type: -

Identifier Source: org_study_id