- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04354597
Hydroxychloroquine and Azithromycin as Prophylaxis for Healthcare Workers Dealing With COVID19 Patients (MOPHYDA)
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 Overview
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Amman, Jordan
- King Hussein Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Subjects will receive weekly HCQ 400mg PO and AZ PO 500mg X 3 Days; weekly for 16 weeks.
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No Intervention: Study Arm B (No treatment)
Subjects will receive no treatment in this group and will be serving as control.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of HCQ and AZ in preventing infection with COVID-19 among healthcare workers working with COVID-19 patients
Time Frame: 4 Months
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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
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4 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of HCQ and AZ
Time Frame: 4 Months
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Solicited and unsolicited adverse events in participants receiving HCQ+AZ during the study period, measured by the incidence of AEs in both arms.
(The difference in type, number, and intensity)
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4 Months
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Oxygen requirement
Time Frame: 4 Months
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The proportion of participants who require oxygen therapy for any indication during the study period in both arms, measured by the requirement for O2 or not in both arms.
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4 Months
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ICU admission
Time Frame: 4 Months
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The proportion of participants who need ICU admission for any reason during the study period in both arms, measured by the incidence of ICU admission in both arms.
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4 Months
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Mortality rate
Time Frame: 4 Months
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The proportion of participants who die of any cause during the study period in both arms, measured by the incidence of death in both arms.
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4 Months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20 KHCC 67
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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