NCT05113810

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

A Pilot, Randomized, Open-label Trial to Determine the Feasibility, Safety, Efficacy, and Pharmacokinetics of Nebulized HCQ01for the Treatment of Patients With COVID-19

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Ministry of Health Jordan · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-20
• Primary completion: 2022-07-20
• Completion: 2022-07-20
• First posted: 2021-11-09
• Last updated: 2022-03-07

Locations

1 site across 1 country: Jordan