COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04337918

Jeremy Road

Chris Miller, chris@sanotize.com (PI email not reported)

2020-04-08

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

prevention 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. 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

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

3

Sanotize Research and Development corp.

19

None

Canada

Close contacts to covid patients

N/A

143

Prevention Study: Measure the effect of NORS on the prevention of COVID-19 infection among health care professionals at risk of exposure to COVID-19;Treatment Sub Study: Measure the efficacy of NORS at reducing the progression of COVID- 19

None

Phase 2

[{"arm_notes": "", "treatment_id": 892, "treatment_name": "Nitric oxide releasing solution", "treatment_type": "Other anti-infectives", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 892, "treatment_name": "Nitric oxide releasing solution", "treatment_type": "Other anti-infectives", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]