Back to results

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

Primary Purpose

COVID-19

Status

Withdrawn

Phase

Not Applicable

Locations

Jordan

Study Type

Interventional

Intervention

HCQ & AZ

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Prophylaxis, Hydroxychloroquine, Azithromycin

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

King Hussein Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Arm A (HCQ & AZ)

Study Arm B (No treatment)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety of HCQ and AZ

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)

Oxygen requirement

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.

ICU admission

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.

Mortality rate

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.

Full Information

NCT ID

NCT04354597

First Posted

April 9, 2020

Last Updated

October 23, 2021

Sponsor

King Hussein Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04354597

Brief Title

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

Acronym

MOPHYDA

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

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Withdrawn

Why Stopped

New data not in favor of prophylaxis using this regimen

Study Start Date

May 1, 2020 (Anticipated)

Primary Completion Date

August 15, 2020 (Anticipated)

Study Completion Date

October 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Hussein Cancer Center

4. Oversight

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.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

COVID-19, Prophylaxis, Hydroxychloroquine, Azithromycin

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Arm A (HCQ & AZ)

Arm Type

Experimental

Arm Description

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

Arm Title

Study Arm B (No treatment)

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

HCQ & AZ

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

4 Months

Secondary Outcome Measure Information:

Title

Safety of HCQ and AZ

Description

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)

Time Frame

4 Months

Title

Oxygen requirement

Description

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.

Time Frame

4 Months

Title

ICU admission

Description

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.

Time Frame

4 Months

Title

Mortality rate

Description

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.

Time Frame

4 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

King Hussein Cancer Center

City

Amman

Country

Jordan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs