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

NCT04354597 | Withdrawn

• 1 other identifier: 20 KHCC 67
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; Prophylaxis; Hydroxychloroquine; Azithromycin

Outcome Measures

Primary Outcomes (1)

• Effect of HCQ and AZ in preventing infection with COVID-19 among healthcare workers working with COVID-19 patients

  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

  4 Months

Secondary Outcomes (4)

• Safety of HCQ and AZ

  4 Months

• Oxygen requirement

  4 Months

• ICU admission

  4 Months

• Mortality rate

  4 Months

Study Arms (2)

Study Arm A (HCQ & AZ)

EXPERIMENTAL

Subjects will receive weekly HCQ 400mg X 1 Day PO and AZ 500mg PO X 3 Days; weekly for 16 weeks.

Drug: HCQ & AZ

Study Arm B (No treatment)

NO INTERVENTION

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

Interventions

HCQ & AZ DRUG

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

Study Arm A (HCQ & AZ)

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Hussein Cancer Center: lead

Study Sites (1)

King Hussein Cancer Center

Amman, Jordan

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman- Department of Pediatrics, Pediatrics Administration

Model Details: 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)

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 21, 2020
• Study Start: May 1, 2020
• Primary Completion: August 15, 2020
• Study Completion: October 15, 2020
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

JO (1)