Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in Individuals With Mild COVID-19

NCT05599919 | Completed Phase 3

• 1 other identifier: GPL/CT/2021/004/III
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 21

Brief Summary

Primary: The primary objective of this study is to evaluate the efficacy of Nitric Oxide Nasal Spray combined with standard supportive care compared with standard supportive care alone in adult subjects with COVID-19 not requiring hospitalization Secondary: The secondary objective is to evaluate the safety and tolerability of Nitric Oxide Nasal Spray combined with standard supportive care compared with standard supportive care alone in adult subjects with COVID-19 not requiring hospitalization.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to evaluate the efficacy of Nitric Oxide Nasal Spray combined with standard supportive care compared with standard supportive care alone in adult subjects with COVID-19 not requiring hospitalization

  Change from baseline in log viral load

  8 days

Secondary Outcomes (1)

• The secondary objective is to evaluate the safety and tolerability of Nitric Oxide Nasal Spray combined with standard supportive care compared with standard supportive care alone in adult subjects with COVID-19 not requiring hospitalization.

  18 days

Study Arms (2)

Patients with COVID-19 (confirmed by RT-PCR), not requiring hospitalization

ACTIVE COMPARATOR

Nitric oxide releasing solution delivered up to 3 times daily

Drug: Nitric Oxide

COVID-19 symptoms

PLACEBO COMPARATOR

saline delivered up to 3 times daily morning, mid-day, and evening. Maximum volume delivered: 0.56 mL Saline @ 0.9%

Drug: Nitric Oxide

Interventions

Nitric Oxide DRUG

The Sponsor designed a dual chamber nasal spray bottle for NORS administration. Components are mixed from two chambers to create the final NO-producing formulation. The liquid contains NO at 0.11 ppm\*hour, which acts as a viricidal agent. Instructions for storing, preparing, and administering the study treatment will be provided to participants.

Also known as: Nasal Spray

COVID-19 symptoms; Patients with COVID-19 (confirmed by RT-PCR), not requiring hospitalization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each subject must meet all of the following criteria to be entered into the randomized treatment in the study:
• Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures
• Age 18-65 years (inclusive) at the time of signing ICF
• Patients with laboratory confirmation of infection with SARS-CoV-2 by positive Rapid Antigen Test for SARS-CoV-2 at screening.
• Recent onset (within 48 hours of time of consent) symptoms of mild COVID-19 with oxygen saturation (SpO2 \> 94 %) and respiratory rate \< 24 breaths/min. Any of the COVID-19 like symptoms including fever, cough, sore throat, malaise, headache, nasal congestion, muscle pain, gastrointestinal symptoms, lack of taste or smell without shortness of breath or dyspnea; (the maximum permitted difference in the time of onset of symptoms and the time of consent is 48 hours)
• For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment urine pregnancy test
• Eligible subjects of child-bearing age (female or male with female partner of childbearing age) must agree to take effective contraceptive measures (including hormonal contraception, barriermethods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment.
• Not participating in any other interventional drug clinical studies before completion of the present study.

You may not qualify if:

• A subject who meets any of the following criteria must not be entered into the randomized treatment in the study:
• Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely
• Subjects with infection requiring oxygen support, invasive or non-invasive ventilator support, extracorporeal membrane oxygenation (ECMO) or shock requiring vasopressor support.
• Current known pneumonia based on x-ray or computed tomography (CT) scan or history of pneumonia within 3 months before screening.
• Requiring hospitalization for the treatment of COVID-19
• Subjects who have received any dose of vaccine for COVID-19
• Prolonged QT, defined as QTcF ≥ 450 milliseconds for men and as QTcF ≥ 470 milliseconds for women
• History of known severely reduced left ventricular (LV) function (Ejection fraction \< 30 %)
• Requires ICU care for management of ongoing clinical status.
• Known allergy or hypersensitivity to Nitric Oxide Nasal Spray.
• History of known severe renal impairment \[creatinine clearance (CrCl) \< 30 mL/min\] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
• Asthma, allergic rhinitis or chronic obstructive lung disease
• Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year).
• Pregnant or lactating women;
• Having used Nitric Oxide Nasal Spray or participated in any other interventional drug clinical study within 30 days prior to first dose of study drug.

Sponsors & Collaborators

• Sanotize Research and Development corp.: lead
• Glenmark Pharmaceuticals Ltd. India: collaborator

Study Sites (21)

Ishwar Institute & Hospital

Aurangabad, 431002, India

Location

MGM Medical College & Hospital

Aurangabad, 431003, India

Location

Bangalore Medical College and Research Institute

Bangalore, 560002, India

Location

Hindusthan Hospital

Coimbatore, 641028, India

Location

Marwari Hospital

Guwahati, 781008, India

Location

St.Theresas Hospital

Hyderabad, 500018, India

Location

Aster Prime Hospital

Hyderabad, 500038, India

Location

Renova Neelima Hospitals

Hyderabad, India

Location

Prakash Institute of Medical Sciences & Research

Islāmpur, 415409, India

Location

Maharaja Agrasen Superspeciality Hospital

Jaipur, 302039, India

Location

Pharmacology Dept. CPR Hospital Campus, Town Hall,

Kolhāpur, 416002, India

Location

C K Birla Hospitals, The Calcutta Medical Research Institute

Kolkata, 700027, India

Location

Peerless Hospitex Hospital And Research Centre Limited

Kolkata, 700094, India

Location

CSI Medical College and Hospital

Kolkata, India

Location

Malabar Medical College Hospital and Research Centre

Kozhikode, 673323, India

Location

Orchid Specialty Hospital

Lohgaon, 411047, India

Location

St. Georges Hospital

Mumbai, 400001, India

Location

Dr Rahul Kodgule

Mumbai, 400099, India

Location

Government Medical College and Hospital Nagpur

Nagpur, 440003, India

Location

All India Institute of Medical Sciences

Nagpur, 441108, India

Location

Lifepoint Multispeciality Hospital

Pune, 411057, India

Location

MeSH Terms

Conditions

COVID-19

Interventions

Nitric Oxide; Nasal Sprays

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Keith Moore, PHARMD

  kmoore@sanotize.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The primary objective of this study is to evaluate the efficacy of Nitric Oxide Nasal Spray combined with standard supportive care compared with standard supportive care alone in adult subjects with COVID-19 not requiring hospitalization

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: October 31, 2022
• Study Start: November 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: February 2, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-02

Locations

IN (21)