NCT04383002 is a Phase 1 clinical trial of Nitric Oxide in COVID-19, sponsored by University Health Network, Toronto.

Who is sponsoring NCT04383002?

NCT04383002 is sponsored by University Health Network, Toronto.

What drugs are being tested in NCT04383002?

Interventions in NCT04383002: Nitric Oxide.

Is NCT04383002 still recruiting?

NCT04383002 is currently completed. Last updated 11 April 2022.

Last reviewed 2022-04-11 · How we verify

NCT04383002

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

High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)

Completed Phase 1 Last updated 11 April 2022

What this trial tests

Phase 1 trial testing Nitric Oxide in COVID-19 in 21 participants. Completed in 11 June 2021.

Timeline

2 September 2020

Primary endpoint
11 May 2021

11 June 2021

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	2 September 2020
Primary completion	11 May 2021
Estimated completion	11 June 2021
Sites	1 location across Canada

Drugs / interventions tested

Nitric Oxide (NITRIC OXIDE) — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Novel therapies are desperately needed for treatment of COVID-19 patients. At present, there are no proven interventions to prevent progression of the disease or to rapidly treat patients with COVID-19 related respiratory failure. Data on the original coronavirus -SARS pneumonia suggested that high dose (\>160ppm) inhaled Nitric Oxide could have beneficial effects also on COVID-19, due to the genomic similarities between these two coronaviruses (1-3). This study will test whether high dose inhaled nitric oxide is safe and can reverse virus burden and respiratory failure in patients on mechanical ventilation.

Publications & conference data

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

The role of NO in COVID-19 and potential therapeutic strategies.
Fang W, Fang W, Jiang J, Su L, et al · · 2021 · cited 72× · PMID 33347987 · DOI 10.1016/j.freeradbiomed.2020.12.008
Nitric Oxide to Fight Viral Infections.
Lisi F, Zelikin AN, Chandrawati R. · · 2021 · cited 65× · PMID 33850691 · DOI 10.1002/advs.202003895
Home Nitric Oxide Therapy for COVID-19.
Alvarez RA, Berra L, Gladwin MT. · · 2020 · cited 63× · PMID 32437250 · DOI 10.1164/rccm.202005-1906ed
Multi-omics-based identification of SARS-CoV-2 infection biology and candidate drugs against COVID-19.
Barh D, Tiwari S, Weener ME, Azevedo V, et al · · 2020 · cited 57× · PMID 33131530 · DOI 10.1016/j.compbiomed.2020.104051
Thromboinflammation in COVID-19 acute lung injury.
Mitchell WB. · · 2020 · cited 54× · PMID 32653469 · DOI 10.1016/j.prrv.2020.06.004
Emerging Mechanisms of Pulmonary Vasoconstriction in SARS-CoV-2-Induced Acute Respiratory Distress Syndrome (ARDS) and Potential Therapeutic Targets.
Karmouty-Quintana H, Thandavarayan RA, Keller SP, Sahay S, et al · · 2020 · cited 42× · PMID 33138181 · DOI 10.3390/ijms21218081
Cancer, immune suppression and Coronavirus Disease-19 (COVID-19): Need to manage drug safety (French Society for Oncology Pharmacy [SFPO] guidelines).
Slimano F, Baudouin A, Zerbit J, Toulemonde-Deldicque A, et al · · 2020 · cited 29× · PMID 32623296 · DOI 10.1016/j.ctrv.2020.102063
Nitric oxide: Clinical applications in critically ill patients.
Redaelli S, Magliocca A, Malhotra R, Ristagno G, et al · · 2022 · cited 28× · PMID 35123061 · DOI 10.1016/j.niox.2022.01.007

Verify or expand the search:

Other trials of Nitric Oxide

Trials testing the same drug.

NCT05801224 — Vascular ARDS Recruitment After Inhaled Nitric Oxide · NA · suspended
NCT06622291 — Perioperative Nitric Oxide Prevents Acute Kidney Injury in Acute Type A Aortic Dissection Patients · Phase 4 · completed
NCT04181359 — The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in Interstitial Lung Disease. · Phase 1, PHASE2 · withdrawn
NCT06120816 — Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis · Phase 1 · completed
NCT06660784 — Mechanism of Nitric Oxide on Ventilator-induced Diaphragm Dysfunction with Extracorporeal Membrane Lung Assistance · active not recruiting

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other University Health Network, Toronto trials

Trials by the same sponsor.

NCT06831032 — Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response · NA · recruiting
NCT06634056 — Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients U · Phase 2 · not yet recruiting
NCT06836726 — Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resis · Phase 2 · not yet recruiting
NCT07515651 — Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas · Phase 2 · not yet recruiting
NCT07509450 — Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cel · NA · not yet recruiting

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 NCT04383002 (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 University Health Network, Toronto
Last refreshed: 11 April 2022

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/NCT04383002.

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