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

• Status: Completed
• Trial end date: 2022-02-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanotize Research and Development corp.
• Collaborator: Glenmark Pharmaceuticals Ltd. India
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

Each subject must meet all of the following criteria to be entered into the randomized treatment in the study:

1. 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

2. Age 18-65 years (inclusive) at the time of signing ICF

3. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive Rapid Antigen Test for SARS-CoV-2 at screening.

4. 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)

5. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment urine pregnancy test

6. 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.

7. Not participating in any other interventional drug clinical studies before completion of the present study.

Exclusion Criteria:

A subject who meets any of the following criteria must not be entered into the randomized treatment in the study:

1. 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

2. Subjects with infection requiring oxygen support, invasive or non-invasive ventilator support, extracorporeal membrane oxygenation (ECMO) or shock requiring vasopressor support.

3. Current known pneumonia based on x-ray or computed tomography (CT) scan or history of pneumonia within 3 months before screening.

4. Requiring hospitalization for the treatment of COVID-19

5. Subjects who have received any dose of vaccine for COVID-19

6. Prolonged QT, defined as QTcF ≥ 450 milliseconds for men and as QTcF ≥ 470 milliseconds for women

7. History of known severely reduced left ventricular (LV) function (Ejection fraction < 30 %)

8. Requires ICU care for management of ongoing clinical status.

9. Known allergy or hypersensitivity to Nitric Oxide Nasal Spray.

10. History of known severe renal impairment [creatinine clearance (CrCl) < 30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis;

11. Asthma, allergic rhinitis or chronic obstructive lung disease

12. Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year).

13. Pregnant or lactating women;

14. 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.

15. Subjects who have received hydroxychloroquine within 7 days before screening or subjects who require hydrochloroquine treatment.

16. Subjects who have received intranasal medication/treatment within 7 days before screening or subjects who require use of any intranasal medication.

17. Subjects who have received medications with antiviral effect such as remdesivir, favipiravir, oseltamivir, ivermectin or inhaled corticosteroids within 7 days before screening or subjects who require use of any of these medications

18. Subjects using nitric oxide donor agents such as prilocaine, sodium nitroprusside and nitroglycerine Duration of study participation: The anticipated maximum total study duration