The Potential Use of Nebulized Hydroxychloroquine for the Treatment of COVID-19
Status:
Not yet recruiting
Trial end date:
2022-05-04
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Ministry of Health Jordan
Collaborators:
ACDIMA Biocenter Amman Pharmaceutical Industries King Hussein Cancer Center Sana Pharmaceutical Industry