COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04622332

Simon Li

simon.li@sironax.com

2020-11-09

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - hospitalized patient with clinical diagnosis of sars-cov-2 virus infection per world health organization criteria including positive nucleic acid test of any specimen (e.g., respiratory, blood, or other bodily fluid) within 2 weeks prior to screening. - symptoms suggestive of severe systemic illness with covid-19, which could include any of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath at rest, or respiratory distress. - clinical signs indicative of severe systemic illness with covid-19, which could include any of the following clinical signs: respiratory rate ≥ 30 per minutes, heart rate ≥ 125 per minute, spo2 ≤ 93% on room air, or pao2/fio2 ratio < 300 mmhg. - men or women ≥18 but ≤80 years of age at the time of signing the informed consent. - patient is able to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).

- patient requires endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 l/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure. - patient with shock defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressor. - patient with multi-organ dysfunction or failure defined by an increase in the sequential organ failure assessment score of 2 points or more. - patient is unlikely to survive beyond 2 days at the discretion of investigator. - patient has used chronic systemic corticosteroids within 2 weeks prior to screening. - patient with positive results for human immunodeficiency virus (hiv) or hepatitis b or c test. - patient has known active tuberculosis (tb), history of uncontrolled tb, suspected or known systemic bacterial or fungal infections within 4 weeks prior to screening. - patient has any other condition, which makes the patient unsuitable for study participation

2

Sironax USA, Inc.

18

80

Mexico;Pakistan;United States

Severe disease at enrollment

6: Severe disease at enrollment

45

Proportion of patients with any TEAEs during the treatment period

None

Phase 1

[{"arm_notes": "", "treatment_id": 1203, "treatment_name": "Sir1-365", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]