COVID-19MOPHYDANCT04354597
Hydroxychloroquine and Azithromycin as Prophylaxis for Healthcare Workers Dealing With COVID19 Patients
A study testing HCQ & AZ in people with COVID-19, run by King Hussein Cancer Center at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- HCQ & AZ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJordan
- Study dates
- 1 May 2020to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- HCQ & AZ
- Keywords
- COVID-19, Prophylaxis, Hydroxychloroquine, Azithromycin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCQ & AZDrug
Subjects will receive weekly HCQ 400mg PO and AZ PO 500mg X 3 Days; weekly for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: HCQ & AZ |
| Study Arm B (No treatment) | No intervention | Subjects will receive no treatment in this group and will be serving as control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 Months
Secondary outcomes (4)
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)
Measured: 4 Months
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.
Measured: 4 Months
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.
Measured: 4 Months
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.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion15 Aug 2020 (estimated)
- Study completion15 Oct 2020 (estimated)
Why it stopped: New data not in favor of prophylaxis using this regimen
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Hussein Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iyad Sultan, King Hussein Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354597
- Sponsor's protocol ID
- 20 KHCC 67
- Acronym
- MOPHYDA
- Status last verified
- Oct 2021
- First submitted
- 9 Apr 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04354597
- Acronym / sponsor ID
- MOPHYDA / 20 KHCC 67
- Conditions
- COVID-19
- Keywords
- COVID-19, Prophylaxis, Hydroxychloroquine, Azithromycin
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: New data not in favor of prophylaxis using this regimen
- Enrolment
- 0 participants (actual)
- Lead sponsor
- King Hussein Cancer CenterUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Study Arm A (HCQ & AZ) | Experimental | Drug: HCQ & AZSubjects will receive weekly HCQ 400mg X 1 Day PO and AZ 500mg PO X 3 Days; weekly for 16 weeks. |
| Study Arm B (No treatment) | No intervention | –Subjects will receive no treatment in this group and will be serving as control. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCQ & AZSubjects will receive weekly HCQ 400mg PO and AZ PO 500mg X 3 Days; weekly for 16 weeks. | Drug | Study Arm A (HCQ & AZ) |
Primary outcome
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
4 secondary outcomes
Safety of HCQ and AZ
Time frame: 4 Months
Oxygen requirement
Time frame: 4 Months
ICU admission
Time frame: 4 Months
Mortality rate
Time frame: 4 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCQ & AZ in people with COVID-19, run by King Hussein Cancer Center at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of HCQ and AZ in preventing infection with COVID-19 among healthcare workers working with COVID-19 patients (time frame: 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.