The Potential Use of Nebulized Hydroxychloroquine for the Treatment of COVID-19

NCT ID: NCT05113810

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-20
• Study Completion Date: 2022-07-20

Brief Summary

This is a pilot, randomized, single-center, parallel group, open-label controlled study to evaluate the feasibility, safety, efficacy, and pharmacokinetics of nebulized HCQ01 plus Standard of Care (SOC) versus SOC alone in hospitalized COVID-19 patients. The Jordanian Ministry of Health (MOH) is the study sponsor, and the study will be conducted at MOH COVID-19 hospitals.

Approximately 110 patients, ≥18 years of age with a confirmed SARS-CoV-2 infection, will be enrolled and randomized 1:1 to the treatment and control arms where they will receive ten doses of Hydroxychloroquine solution via nebulizer in addition to SOC or the control arm where treatment will follow the MOH SOC.

Conditions

2019 Novel Coronavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

First Arm (Hydroxychloroquine sulfate, 5 days)

Participants will receive continued standard of care therapy (SOC) for COVID-19 together with 2 ml HCQ01 (12.5 mg/ml) twice a day for 5 consecutive days.

Group Type: EXPERIMENTAL

HCQ01

Intervention Type: DRUG

HCQ01 is a sterile, clear and colorless, ready-to-use aqueous nebulizer solution. Hydroxychloroquine sulfate administered via nebulization

Second Arm (Continued Standard of Care (SOC) Therapy)

Participants will receive continued standard of care therapy for COVID-19

Group Type: ACTIVE_COMPARATOR

standard of care (SOC) for COVID-19

Intervention Type: OTHER

Standard of care (SOC) for COVID-19

Interventions

HCQ01

HCQ01 is a sterile, clear and colorless, ready-to-use aqueous nebulizer solution. Hydroxychloroquine sulfate administered via nebulization

Intervention Type: DRUG

standard of care (SOC) for COVID-19

Standard of care (SOC) for COVID-19

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Hussein Cancer Center

OTHER

Sponsor Role: collaborator

ACDIMA Biocenter

OTHER

Sponsor Role: collaborator

Amman Pharmaceutical Industries

UNKNOWN

Sponsor Role: collaborator

Sana Pharmaceutical Industry

UNKNOWN

Sponsor Role: collaborator

Ministry of Health Jordan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Feras Hawari, MD

Role: PRINCIPAL_INVESTIGATOR

The Jordanian Ministry of Health

Locations

Prince Hamza Hospital/ Amman Field Hospital

Amman, , Jordan

Site Status: RECRUITING

Countries

Jordan

Central Contacts

Yasmeen Dodin, MSc

Role: CONTACT

YD.14502@KHCC.JO

00962798950958

Facility Contacts

Khaldoun Khader, MD

Role: primary

Mohammed Shakeeb, MSc

Role: backup

mshakeeb95@gmail.com

0781633832

Other Identifiers

1093-2021

Identifier Type: -

Identifier Source: org_study_id