NCT04731051 is a Phase 1/Phase 2 clinical trial of HCQ01 in 2019 Novel Coronavirus, sponsored by King Hussein Cancer Center.

Who is sponsoring NCT04731051?

NCT04731051 is sponsored by King Hussein Cancer Center.

What drugs are being tested in NCT04731051?

Interventions in NCT04731051: HCQ01, standard of care (SOC) for COVID-19.

What condition does NCT04731051 study?

NCT04731051 studies 2019 Novel Coronavirus.

Is NCT04731051 still recruiting?

NCT04731051 is currently withdrawn. Last updated 5 April 2023.

Last reviewed 2023-04-05 · How we verify

NCT04731051

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Withdrawn Phase 1/Phase 2 Last updated 5 April 2023

What this trial tests

Phase 1/Phase 2 trial testing HCQ01 in 2019 Novel Coronavirus. Withdrawn.

Timeline

1 October 2022

Primary endpoint
1 November 2022

1 December 2022

Quick facts

Lead sponsor	King Hussein Cancer Center
Phase	Phase 1/Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 October 2022
Primary completion	1 November 2022
Estimated completion	1 December 2022
Sites	1 location across Jordan

Drugs / interventions tested

HCQ01 — full drug profile →
standard of care (SOC) for COVID-19 — full drug profile →

Conditions studied

2019 Novel Coronavirus — all drugs for 2019 Novel Coronavirus →

Sponsor

King Hussein Cancer Center — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Proportion of participants who improve by at least one level lower on the 11-point World Health Organization Ordinal Scale for Clinical Improvement (WHO-OSCI), where patients are scored on a scale of 0-10 with 0 being uninfected and 10 being dead .
Time frame: Time Frame: Day 14

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 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

A roadmap to pulmonary delivery strategies for the treatment of infectious lung diseases.
He S, Gui J, Xiong K, Chen M, et al · · 2022 · cited 91× · PMID 35241085 · DOI 10.1186/s12951-022-01307-x
Nebulised Isotonic Hydroxychloroquine Aerosols for Potential Treatment of COVID-19.
Tai W, Chow MYT, Chang RYK, Tang P, et al · · 2021 · cited 10× · PMID 34452220 · DOI 10.3390/pharmaceutics13081260

Verify or expand the search:

Other trials of HCQ01

Trials testing the same drug.

NCT05113810 — The Potential Use of Nebulized Hydroxychloroquine for the Treatment of COVID-19 · Phase 2 · unknown

Other King Hussein Cancer Center trials

Trials by the same sponsor.

NCT07271121 — Study of CART Cell (MB-CART19.1) in Patients With Relapsed or Refractory CD19 Positive NHL · Phase 2 · recruiting
NCT06689358 — Thoracic Paravertebral Block for Postoperative Pain Management After VATS · NA · completed
NCT04374903 — Hydroxychloroquine in Combination With Sirolimus and Dexamethasone for Treating COVID-19 Patients · NA · withdrawn
NCT04920513 — Universal- Versus Guidelines-Directed Genetic Testing for Germline Pathogenic Variants Utilizing a Multi-Gene Panel for · completed
NCT04920656 — Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04731051 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by King Hussein Cancer Center
Last refreshed: 5 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04731051.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing