drugset / Trial / NCT05113810
The Potential Use of Nebulized Hydroxychloroquine for the Treatment of COVID-19
Phase 2
Unknown
110 enrolled
Ministry of Health Jordan
ACDIMA Biocenter · collabAmman Pharmaceutical Industries · collabKing Hussein Cancer Center · collabSana Pharmaceutical Industry · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-03-20
- Primary completion
- 2022-07-20
- Completion
- 2022-07-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxychloroquine | Small molecule | 2 ml | Inhaled |