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Purpose

Primary Objective: • To evaluate overall safety and tolerability of SIR1-365 in patients with severe COVID-19 Secondary Objectives: - To assess the clinical efficacy of SIR1-365 in patients with severe COVID-19 - To assess the effects of SIR1-365 on multiple inflammatory biomarker levels including C-reactive protein (CRP), ferritin, lymphocyte and neutrophil counts, cytokines, and chemokines - To assess the effects of SIR1-365 on biomarkers indicative of target engagement in patients with severe COVID-19 - To assess the effects of SIR1-365 on biomarkers indicative of kidney injury in patients with severe COVID-19 - To assess the effects of SIR1-365 on biomarkers indicative of cardiovascular endothelial cell damage in patients with severe COVID-19 - To characterize plasma pharmacokinetics (PK) of SIR1-365 in patients with severe COVID-19

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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).

Exclusion Criteria

  • 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Blinded

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SIR1-365 		SIR1-365 dose 1 daily for 14 days
  • Drug: SIR1-365
    Route of administration: oral
    Other names:
    • Pharmaceutical form: tablets
Placebo Comparator
Matching placebo 		Matching placebo dose 1 daily for 14 days
  • Drug: Matching Placebo
    Route of administration: oral
    Other names:
    • Pharmaceutical form: tablets

Recruiting Locations

More Details

NCT ID
NCT04622332
Status
Completed
Sponsor
Sironax USA, Inc.

Detailed Description

Study duration per participant is approximately 28 days including a 14-day treatment period

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.