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

NCT05113810 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-03-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • King Hussein Cancer Center

    collaborator OTHER

  • ACDIMA Biocenter

    collaborator OTHER

  • Amman Pharmaceutical Industries

    collaborator UNKNOWN

  • Sana Pharmaceutical Industry

    collaborator UNKNOWN

  • Ministry of Health Jordan

    lead OTHER_GOV

Principal Investigators

  • Feras Hawari, MD · The Jordanian Ministry of Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-20
Primary Completion
2022-07-20
Completion
2022-07-20

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05113810 on ClinicalTrials.gov