A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19
Public ClinicalTrials.gov record NCT04622332. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04622332
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 45 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 18, 2020 (Actual)
- Primary completion
- Nov 27, 2021 (Actual)
- Completion
- Nov 27, 2021 (Actual)
- Last update posted
- Nov 12, 2025
2020 – 2021
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Triple O Research Institute | West Palm Beach | Florida | 33407 | — |
| OSF St. Francis Medical Center | Peoria | Illinois | 61637 | — |
| Baptist Medical Center | Jackson | Mississippi | 39202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04622332, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 12, 2025 · Synced Oct 2, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04622332 live on ClinicalTrials.gov.