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The Potential Use of Inhaled Hydroxychloroquine for the Treatment of COVID-19 in Cancer Patients

NCT04731051 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-04-07

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 cancer patients with COVID-19. King Hussein Cancer Center (KHCC) is the study sponsor, and the study will be conducted at KHCC COVID-19 wards.

Approximately 28 cancer 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 KHCC 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

DRUG

standard of care (SOC) for COVID-19

Standard of care (SOC) for COVID-19

Sponsors & Collaborators

  • Amman Pharmaceutical Industries (API)

    collaborator UNKNOWN

  • Sana Pharmaceutical Industry

    collaborator UNKNOWN

  • ACDIMA Biocenter

    collaborator OTHER

  • King Hussein Cancer Center

    lead OTHER

Principal Investigators

  • Feras Hawari, MD · King Hussein Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2022-11-30
Completion
2022-12-31

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 NCT04731051 on ClinicalTrials.gov