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

NCT ID: NCT04622332

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-18
• Study Completion Date: 2021-11-27

Brief Summary

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

Detailed Description

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

Conditions

Corona Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SIR1-365

SIR1-365 dose 1 daily for 14 days

Group Type: EXPERIMENTAL

SIR1-365

Intervention Type: DRUG

Route of administration: oral

Matching placebo

Matching placebo dose 1 daily for 14 days

Group Type: PLACEBO_COMPARATOR

Matching Placebo

Intervention Type: DRUG

Route of administration: oral

Interventions

SIR1-365

Route of administration: oral

Intervention Type: DRUG

Matching Placebo

Route of administration: oral

Intervention Type: DRUG

Other Intervention Names

Pharmaceutical form: tablets; Pharmaceutical form: tablets

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sironax USA, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clare Qu

Role: STUDY_DIRECTOR

Sironax USA, Inc.

Locations

Triple O Research Institute

West Palm Beach, Florida, United States

OSF St. Francis Medical Center

Peoria, Illinois, United States

Baptist Medical Center

Jackson, Mississippi, United States

Hospital Civil Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

Media Sur - Medica Sur Tlalpan

Tlalpan, Mexico City, Mexico

Hospital Universitario "Dr. José Eleuterio González"

Monterrey, Nuevo León, Mexico

Dow University Hospital, Ojha Karachi

Karachi, Sindh, Pakistan

Sindh Infectious Disease Hospital

Karachi, Sindh, Pakistan

Aga Khan University Hospital

Karachi, Sindh, Pakistan

Countries

United States; Mexico; Pakistan

References

Chavez-Tapia N, Sayeed MA, Luxmi S, Kasper DJ, Xue F, Shen Y, Fan W, Yuan W, Du B. Safety and efficacy of selective RIPK1 inhibitor SIR1-365 in hospitalized patients with severe COVID-19: A multicenter, randomized, double-blind, phase 1b trial. J Intensive Med. 2024 Sep 12;5(1):70-78. doi: 10.1016/j.jointm.2024.07.003. eCollection 2025 Jan.

Reference Type: DERIVED

PMID: 39872839 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SIR365-US-101

Identifier Type: -

Identifier Source: org_study_id