Hydroxychloroquine and Azithromycin as Prophylaxis for Healthcare Workers Dealing With COVID19 Patients (MOPHYDA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04354597|
Recruitment Status : Not yet recruiting
First Posted : April 21, 2020
Last Update Posted : May 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: HCQ & AZ||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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)
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||August 15, 2020|
|Estimated Study Completion Date :||October 15, 2020|
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.
Drug: HCQ & AZ
Subjects will receive weekly HCQ 400mg PO and AZ PO 500mg X 3 Days; weekly for 16 weeks.
No Intervention: Study Arm B (No treatment)
Subjects will receive no treatment in this group and will be serving as control.
- Effect of HCQ and AZ in preventing infection with COVID-19 among healthcare workers working with COVID-19 patients [ Time Frame: 4 Months ]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
- Safety of HCQ and AZ [ Time Frame: 4 Months ]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 [ Time Frame: 4 Months ]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 [ Time Frame: 4 Months ]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 [ Time Frame: 4 Months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354597
|Contact: Iyad Sultan, MD||+96265300460 ext firstname.lastname@example.org|
|Contact: Nedal Al-Rawashdeh, MPHemail@example.com|
|King Hussein Cancer Center|
|Contact: Iyad Sultan, MD firstname.lastname@example.org|
|Contact: Nedal Al-Rawashdeh, MPH email@example.com|
|Principal Investigator: Iyad Sultan, MD|
|Sub-Investigator: Hikmat Abdel-Razeq, MD|
|Sub-Investigator: Osama Abu Ata, MD|
|Sub-Investigator: Amal Al Omari, PhD|
|Sub-Investigator: Lama Nazer, PharmD|
|Sub-Investigator: Rana Damsees, MPH|
|Sub-Investigator: Dalia Al Rimawi, MDS|
|Sub-Investigator: Iyad Al-Ammouri, MD|