NCT03331445

Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections

Terminated Phase 2 Last updated 16 July 2021

What this trial tests

Phase 2 trial testing Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation in Respiratory Tract Infections in 13 participants. Terminated before completion.

Timeline

24 October 2017

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Chris Miller
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	24 October 2017
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across Canada

Drugs / interventions tested

• Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation — full drug profile →

Conditions studied

• Respiratory Tract Infections — all drugs for Respiratory Tract Infections →
• Corona Virus Infection — all drugs for Corona Virus Infection →

Sponsor

Chris Miller — full company profile →

Who can join

19 and older, any sex, with Respiratory Tract Infections or Corona Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Non tuberculous mycobacteria (NTM), Burkholdria spp, Aspergillus in the lung are almost impossible to eradicate with conventional antibiotics. In addition COVID-19 has know current treatment. These patients have few options to treat their lung infection. Nitric oxide has broad bactericidal and virucidal properties. It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the lungs. Further, research indicates that clinical isolates of NTM, Burkholderia spp, Aspergillus spp and Corona-like viruses can be eradicated by 160ppm NO exposure in the laboratory petri dish. This is not the first time inhaled NO treatment has been used in patients with difficult lung infections. This study will provide more data to see if NO therapy can reduce the bacterial load in the lungs, help the patients breath better; and in the case of COVID-19 act as a anti-viral agent resulting in the reduction of incidence of oxygen therapy, mechanical assistance of BIPAP, CPAP, intubation and mechanical ventilation during the study period.

Publications & conference data

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

1. COVID-19: Transmission, prevention, and potential therapeutic opportunities.
   Lotfi M, Hamblin MR, Rezaei N. · · 2020 · cited 447× · PMID 32474009 · DOI 10.1016/j.cca.2020.05.044
2. 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
3. Nitric Oxide to Fight Viral Infections.
   Lisi F, Zelikin AN, Chandrawati R. · · 2021 · cited 65× · PMID 33850691 · DOI 10.1002/advs.202003895
4. Home Nitric Oxide Therapy for COVID-19.
   Alvarez RA, Berra L, Gladwin MT. · · 2020 · cited 63× · PMID 32437250 · DOI 10.1164/rccm.202005-1906ed
5. Nitric oxide and viral infection: Recent developments in antiviral therapies and platforms.
   Garren MR, Ashcraft M, Qian Y, Douglass M, et al · · 2021 · cited 51× · PMID 38620577 · DOI 10.1016/j.apmt.2020.100887
6. Targeting the NO-cGMP-PDE5 pathway in COVID-19 infection. The DEDALO project.
   Isidori AM, Giannetta E, Pofi R, Venneri MA, et al · · 2021 · cited 48× · PMID 32526061 · DOI 10.1111/andr.12837
7. The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days.
   Janiaud P, Axfors C, Van't Hooft J, Saccilotto R, et al · · 2020 · cited 46× · PMID 33082937 · DOI 10.12688/f1000research.26707.2
8. Inhalation Delivery for the Treatment and Prevention of COVID-19 Infection.
   Eedara BB, Alabsi W, Encinas-Basurto D, Polt R, et al · · 2021 · cited 43× · PMID 34371768 · DOI 10.3390/pharmaceutics13071077