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

NCT05113810 | Unknown Phase 2 DMC

• 1 other identifier: 1093-2021
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

COVID-19; Inhaled/nebulized Hydroxychloroquine

Outcome Measures

Primary Outcomes (1)

• WHO Ordinal Scale for for Clinical Improvement

  Change in condition measured using the Ordinal Scale for Clinical Improvement. Patients are scored on a scale of 0-10 with 0 being uninfected and 10 being dead

  [ Day -1 (screening) to Days 3,6, and 14 ]

Secondary Outcomes (10)

• Proportion of participants who improve by at least one level lower on the 11-point WHO-OSCI

  Day 28

• All-cause mortality

  Day 28

• HCQ concentration in plasma versus time profiles

  Day 1 pre-dose (within 1-hour prior dosing) and +2, +5, +10, +15, +20, +25, and +30 minutes after dose, and also +1, +2, +3, +4 and +6 hours post-dose completion

• Change from Baseline Oxygenation as determined by the SpO2/FiO2 ratio

  Days 3 & 6

• Rate of Transfer to the Intensive Care Unit

  Up to day 28

Study Arms (2)

First Arm (Hydroxychloroquine sulfate, 5 days)

EXPERIMENTAL

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.

Drug: HCQ01

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

ACTIVE COMPARATOR

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

Other: standard of care (SOC) for COVID-19

Interventions

HCQ01 DRUG

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

First Arm (Hydroxychloroquine sulfate, 5 days)

standard of care (SOC) for COVID-19 OTHER

Standard of care (SOC) for COVID-19

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at screening.
• 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.
• Patients admitted in ICU.
• 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.
• History of Glucose-6-phosphate dehydrogenase deficiency.
• Pre-treatment corrected QT interval (QTc) ≥450 milliseconds.

You may not qualify if:

• Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at screening.
• 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.
• Patients admitted in ICU.
• 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.
• History of Glucose-6-phosphate dehydrogenase deficiency.
• Pre-treatment corrected QT interval (QTc) ≥450 milliseconds.
• Acute or chronic kidney disease (stage-4 or -5 renal impairment; eGFR\<30 mL/min/1.73 m2 or hemodialysis).
• Liver Child-Pugh grade C.
• Patients with Hypokalemia (\<3.5mmol/L), Hypocalcemia (\<2.2mmol/L), Hypomagnesemia (\<0.66mmol/L). Will be included after correction.
• Need for mechanical ventilation.
• History of hypersensitivity to hydroxychloroquine.
• History of Chronic Hepatitis B or hepatitis C infections.
• History of Human Immunodeficiency Virus (HIV) infection.
• 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).

Sponsors & Collaborators

• Ministry of Health Jordan: lead
• King Hussein Cancer Center: collaborator
• ACDIMA Biocenter: collaborator
• Amman Pharmaceutical Industries: collaborator
• Sana Pharmaceutical Industry: collaborator

Study Sites (1)

Prince Hamza Hospital/ Amman Field Hospital

Amman, 00962, Jordan

RECRUITING

MeSH Terms

Conditions

COVID-19; Respiratory Aspiration

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Feras Hawari, MD

  The Jordanian Ministry of Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmeen Dodin, MSc

CONTACT

00962798950958; YD.14502@KHCC.JO

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: November 9, 2021
• Study Start: March 20, 2022
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)