NCT04731051

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

A Pilot, Randomized, Open-label Trial to Determine the Feasibility, Safety, Efficacy, and Pharmacokinetics of Nebulized HCQ01 for the Treatment of Patients With COVID-19 and Cancer

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: King Hussein Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-10-01
• Primary completion: 2022-11-01
• Completion: 2022-12-01
• First posted: 2021-01-29
• Last updated: 2023-04-07

Locations

1 site across 1 country: Jordan