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NCT05113810

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

Status unknown Phase 2 Last updated 7 March 2022
What this trial tests

Phase 2 trial testing HCQ01 in 2019 Novel Coronavirus in 110 participants. Status unknown.

Timeline
20 March 2022
Primary endpoint
20 July 2022
20 July 2022

Quick facts

Lead sponsorMinistry of Health Jordan
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment110
Start date20 March 2022
Primary completion20 July 2022
Estimated completion20 July 2022
Sites1 location across Jordan

Drugs / interventions tested

Conditions studied

Sponsor

Ministry of Health Jordan

Who can join

18 and older, any sex, with 2019 Novel Coronavirus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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