Nitric Oxide Releasing Solutions to Prevent and Treat Mild/Moderate COVID-19 Infection

• Status: Completed
• Trial end date: 2021-02-02
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, randomized, controlled, phase II clinical efficacy study evaluating a novel Nitric Oxide Releasing Solution (NORS) treatment for the prevention and treatment of COVID-19 in healthcare workers at risk of infection. Participants will be enrolled into one of two components of this study. Based on initial swabs/symptoms, volunteers who are COVID-19 negative will be enrolled in the Prevention study and randomized to receive standard institutional precautions or standard institutional precautions + NORS. Those who are COVID-19 positive will be enrolled in the open-label Treatment Sub-Study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanotize Research and Development corp.
• Collaborators: Keyrus Life Science; The Emmes Company, LLC
• Treatments: Nitric Oxide; Pharmaceutical Solutions

Criteria

Prevention Study Inclusion Criteria:

1. Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;

2. Men and Women ≥ 19 years of age unless local laws dictate otherwise;

3. English speaking;

4. Must be willing to use an adequate form of contraception (or abstinence) from the time of the first dose with the IMP until after the last dose of IMP.

5. Be symptom-free at screening/baseline.

6. Work/live in contact with COVID-19 infected patients or scheduled to work in a setting with high likelihood of contact with COVID-19 infected patients.

Prevention Study Exclusion Criteria:

1. Prior Tracheostomy;

2. Concomitant treatment of respiratory support (involving any form of oxygen therapy);

3. Any clinical contraindications, as judged by the attending physician;

4. Any symptoms consistent with COVID-19;

5. Pregnant;

6. Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study;

7. Prior COVID-19 infection.

Treatment Sub study Inclusion Criteria:

1. Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;

2. Men and Women ≥ 19 years of age unless local laws dictate otherwise;

3. English speaking;

4. Must be willing to use an adequate form of contraception (or abstinence) from the time of the first dose with the IMP until after the last dose of IMP;

5. Positive COVID-19 test or presentation of clinical symptoms defined as fatigue with either fever >37.2 (oral) and/or a persistent cough.

Treatment Sub Study Exclusion Criteria:

1. Prior Tracheostomy;

2. Concomitant treatment of respiratory support (involving any form of oxygen therapy); Any clinical contraindications, as judged by the attending physician;

3. Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study;

4. Pregnant;

5. Currently hospitalized for symptoms of COVID-19.