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A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19

NCT04622332•Sironax USA, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (9)

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

Key Dates

Start Date

December 18, 2020

Primary Completion Date

November 27, 2021

Completion Date

November 27, 2021

Last Updated

November 12, 2025

Enrollment

ACTUAL participants

Conditions

Corona Virus Infection

Interventions

SIR1-365

DRUG

Matching Placebo

DRUG

Kidney in Coronavirus Disease 2019 Registry

NCT04797091

Corona Virus InfectionSARS-CoV 2

View study

WITHDRAWNPHASE2

Subcutaneous Sarilumab vs Placebo in Hospitalized Patients With Respiratory Distress Caused by COVID 19

NCT07196306

COVIDCOVID-19+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Kidney in Coronavirus Disease 2019 Registry

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