Status:
COMPLETED
Nitric Oxide Releasing Solutions to Prevent and Treat Mild/Moderate COVID-19 Infection
Lead Sponsor:
Sanotize Research and Development corp.
Collaborating Sponsors:
The Emmes Company, LLC
Keyrus Life Science
Conditions:
Corona Virus Infection
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief 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 hea...
Detailed Description
The novel, human-infecting corona-virus, provisionally named 2019 novel corona virus (2019-nCoV) is a single-strand, positive-sense RNA virus and has a similar receptor-binding domain structure to tha...
Eligibility Criteria
Inclusion
- Prevention Study
- Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;
- Men and Women ≥ 19 years of age unless local laws dictate otherwise;
- English speaking;
- 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.
- Be symptom-free at screening/baseline.
- 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
- Prior Tracheostomy;
- Concomitant treatment of respiratory support (involving any form of oxygen therapy);
- Any clinical contraindications, as judged by the attending physician;
- Any symptoms consistent with COVID-19;
- Pregnant;
- Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study;
- Prior COVID-19 infection.
- Treatment Sub study Inclusion Criteria:
- Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;
- Men and Women ≥ 19 years of age unless local laws dictate otherwise;
- English speaking;
- 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;
- 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
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2021
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT04337918
Start Date
May 8 2020
End Date
February 2 2021
Last Update
February 10 2021
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
BC Diabetes
Vancouver, British Columbia, Canada, V5Y 3W2
2
LMC Manna
Pointe-Claire, Quebec, Canada, H9R 4S3
3
Diex Recherche Québec
Québec, Quebec, Canada, G1N 4V3
4
Diex Recherche Joliette
Saint-Charles-Borromée, Quebec, Canada, J6E 2B4