A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19

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

  • Corona Virus Infection

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