Phase 2
Completed N=25
Safety and Efficacy of Trans Sodium Crocetinate (TSC) in SARS-CoV-2 (COVID-19) Infected Subjects
SARS-CoV-2 (Covid19)
Source: ClinicalTrials.gov NCT04573322 ↗
Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Apr 2022
Primary outcomePrimary: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) — 3; 4; 5; 2 Participants
Summary
This study will assess the safety and efficacy of TSC as a treatment for participants who are infected with SARS-CoV-2 (COVID-19).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) |
3; 4; 5; 2; 1; 1 | — |
| PRIMARY Time to Recovery Through Day 28 |
14.33; 13.67; 7.71; 7.50 | — |
| SECONDARY Change From Baseline in WHO Ordinal Severity Scale as a Categorical Improvement or Worsening |
0; 1; 0; 0; 3; 3 | — |
| SECONDARY Oxygenation - Ventilator Free Days |
19.7; 16.00; 15.43; 19.83 | — |
| SECONDARY Hospital Length of Stay |
8.67; 9.67; 8.57; 8.00 | — |
| SECONDARY Oxygenation - Time to Return to Baseline |
7.50; 18.92; 11.79; 5.50 | — |
| SECONDARY Oxygenation - Pulse Oximetry |
261.83; 164.33; 183.97; 255.03; 261.83; 164.33 | — |
Eligibility Criteria
Inclusion Criteria
- Hospitalized subjects with confirmed SARS-CoV-2 infection and hypoxemia, defined as SpO2 10)
- Patient or LAR unable to provide written informed consent
- ALT/AST > 3 times the upper limit of normal or serum bilirubin > 1.5 times the upper limit of normal
- Estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) formula < 30 mL/min/1.73 m^2 or on dialysis
- Pregnancy or breast feeding.
- Anticipated transfer to another hospital which is not a study site within 72 hours.
- Allergy to any study medication
Data sourced from ClinicalTrials.gov (NCT04573322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.