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WithdrawnNCT04354597MOPHYDAUpdated Oct 26, 2021

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

An interventional study of HCQ & AZ in COVID-19, sponsored by King Hussein Cancer Center. Withdrawn at 1 site in Jordan. Open to participants aged 25 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-26.

Sponsored by King Hussein Cancer Center · Not applicable, Interventional, and Prevention

Why this study was withdrawn
New data not in favor of prophylaxis using this regimen
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • COVID-19

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Keywords

  • COVID-19
  • Prophylaxis
  • Hydroxychloroquine
  • Azithromycin
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

Browse COVID-19 studies →

Lead sponsor

King Hussein Cancer Center is the lead sponsor of 23 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

  • No intervention
    Study Arm B (No treatment)

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

Interventions

  • DrugHCQ & AZ

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

06

What researchers measure

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

    Time frame: 4 Months

Secondary outcomes

  1. 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)

    Time frame: 4 Months

  2. 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.

    Time frame: 4 Months

  3. 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.

    Time frame: 4 Months

  4. 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.

    Time frame: 4 Months

07

Study locations

1 site
  • King Hussein Cancer Center
    Amman, Jordan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04354597
Lead sponsor
King Hussein Cancer Center
Responsible party
Iyad Sultan (Chairman- Department of Pediatrics, Pediatrics Administration, King Hussein Cancer Center) — Principal investigator
First posted
Apr 21, 2020
Start date
May 1, 2020 (estimated)
Primary completion
Aug 15, 2020 (estimated)
Completion
Oct 15, 2020 (estimated)
Last update
Oct 26, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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