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Experimental COVID-19 drug passes early safety check in small trial

NCT ID NCT04622332

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

45 people

The number who actually took part.

Started

Dec 2020

Finished

Nov 2021

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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

  • Aga Khan University Hospital

    Karachi, Sindh, 74800, Pakistan

  • Baptist Medical Center

    Jackson, Mississippi, 39202, United States

  • Dow University Hospital, Ojha Karachi

    Karachi, Sindh, 74200, Pakistan

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara, Jalisco, 14050, Mexico

  • Hospital Universitario "Dr. José Eleuterio González"

    Monterrey, Nuevo León, 64460, Mexico

  • Media Sur - Medica Sur Tlalpan

    Tlalpan, Mexico City, 14050, Mexico

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637, United States

  • Sindh Infectious Disease Hospital

    Karachi, Sindh, 74200, Pakistan

  • 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.