Experimental COVID-19 drug passes early safety check in small trial
NCT ID NCT04622332
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new drug called SIR1-365 in 45 hospitalized adults with severe COVID-19. The main goal was to see if the drug is safe and tolerable. Researchers also looked at whether it could reduce inflammation and improve patient outcomes. The trial was completed, but results are not yet published.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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45 people
The number who actually took part.
- Started
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Dec 2020
- Finished
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Nov 2021
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aga Khan University Hospital
Karachi, Sindh, 74800, Pakistan
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Baptist Medical Center
Jackson, Mississippi, 39202, United States
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Dow University Hospital, Ojha Karachi
Karachi, Sindh, 74200, Pakistan
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Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 14050, Mexico
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Hospital Universitario "Dr. José Eleuterio González"
Monterrey, Nuevo León, 64460, Mexico
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Media Sur - Medica Sur Tlalpan
Tlalpan, Mexico City, 14050, Mexico
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OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
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Sindh Infectious Disease Hospital
Karachi, Sindh, 74200, Pakistan
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Triple O Research Institute
West Palm Beach, Florida, 33407, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a mild case of COVID-19 harm your kidneys? urine tests may hold the answer
- Pandemic pregnancy: tracking COVID's impact on mothers and babies
- Experimental drug aims to tame severe COVID-19 inflammation
- Major trial tests new antibody drug for hospitalized COVID-19 patients
- Can early COVID-19 drugs keep high-risk patients out of the hospital?