This is a pilot, randomized, single-center, parallel group, open-label controlled studyto evaluate the feasibility, safety, efficacy, and pharmacokinetics of nebulized HCQ01plus Standard of Care (SOC) versus SOC alone in hospitalized COVID-19 patients. TheJordanian Ministry of Health (MOH) is the study sponsor, and the study will be conductedat MOH COVID-19 hospitals.Approximately 110 patients, ≥18 years of age with a confirmed SARS-CoV-2 infection, willbe enrolled and randomized 1:1 to the treatment and control arms where they will receiveten doses of Hydroxychloroquine solution via nebulizer in addition to SOC or the controlarm where treatment will follow the MOH SOC.
Not Provided
Drug: HCQ01
HCQ01 is a sterile, clear and colorless, ready-to-use aqueous nebulizer solution.
Hydroxychloroquine sulfate administered via nebulization
Other: standard of care (SOC) for COVID-19
Standard of care (SOC) for COVID-19
Inclusion Criteria:
1. Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female
at screening.
2. Patients with a history of retinopathy, sickle cell disease or trait, psoriasis,
porphyria, history of splenectomy, mental illness or uncontrolled seizures disorder,
known active tuberculosis or history of incompletely treated tuberculosis, patients
on chronic immunosuppression for other medical conditions such as rheumatological
disorders, inflammatory bowel disease, or in patients with organ transplants.
3. Patients admitted in ICU.
4. Taking medications which may lead to interactions with hydroxychloroquine, including
penicillamine, telbivudine, botulinum toxin, fluconazole, digoxin, propafenone ,
cimetidine, statins, warfarin, and cyclosporine within 2 weeks of dosing start, and
during the duration of the study.
5. History of Glucose-6-phosphate dehydrogenase deficiency.
6. Pre-treatment corrected QT interval (QTc) ≥450 milliseconds.
Exclusion Criteria:
1. Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female
at screening.
2. Patients with a history of retinopathy, sickle cell disease or trait, psoriasis,
porphyria, history of splenectomy, mental illness or uncontrolled seizures disorder,
known active tuberculosis or history of incompletely treated tuberculosis, patients
on chronic immunosuppression for other medical conditions such as rheumatological
disorders, inflammatory bowel disease, or in patients with organ transplants.
3. Patients admitted in ICU.
4. Taking medications which may lead to interactions with hydroxychloroquine, including
penicillamine, telbivudine, botulinum toxin, fluconazole, digoxin, propafenone ,
cimetidine, statins, warfarin, and cyclosporine within 2 weeks of dosing start, and
during the duration of the study.
5. History of Glucose-6-phosphate dehydrogenase deficiency.
6. Pre-treatment corrected QT interval (QTc) ≥450 milliseconds.
7. Acute or chronic kidney disease (stage-4 or -5 renal impairment; eGFR<30 mL/min/1.73
m2 or hemodialysis).
8. Liver Child-Pugh grade C.
9. Patients with Hypokalemia (<3.5mmol/L), Hypocalcemia (<2.2mmol/L), Hypomagnesemia
(<0.66mmol/L). Will be included after correction.
10. Need for mechanical ventilation.
11. History of hypersensitivity to hydroxychloroquine.
12. History of Chronic Hepatitis B or hepatitis C infections.
13. History of Human Immunodeficiency Virus (HIV) infection.
14. Concurrent serious illness including, but not limited to, any of the following:
- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension,
myocardial infarction, or unstable angina).
- New York Heart Association class II-IV congestive heart failure.
- Serious cardiac arrhythmia requiring medication. -Peripheral vascular disease ≥
grade 2 within the past year. -
- Psychiatric illness/social situation that would limit compliance with study
requirements. -COPD, Lung cancer, and moderate to severe asthma.
15. Any other significant finding based on the judgment of the PI would increase the
risk of having an adverse outcome from participating in this study.
16. Any other concomitant treatment based on the judgment of the PI would increase the
risk of having an adverse outcome from participating in this study.
17. Is currently participating in or has participated in an interventional clinical
trial with an investigational compound or device within 80 days of signing the
informed consent/assent for this current trial.
Prince Hamza Hospital/ Amman Field Hospital
Amman, Jordan
Investigator: Khaldoun Khader, MD
Yasmeen Dodin, MSc
00962798950958
YD.14502@KHCC.JO
Feras Hawari, MD, Principal Investigator
The Jordanian Ministry of Health