Overview
Safety and Efficacy of Trans Sodium Crocetinate (TSC) in SARS-CoV-2 (COVID-19) Infected Subjects
Status:
Completed
Completed
Trial end date:
2021-04-29
2021-04-29
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Diffusion Pharmaceuticals IncTreatments:
Trans-sodium crocetinate
Criteria
Inclusion Criteria:1. Hospitalized subjects with confirmed SARS-CoV-2 infection and hypoxemia, defined as
SpO2 < 94% on room air or requiring supplemental oxygen
2. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or
public health assay in any specimen < 72 hours prior to enrollment.
3. WHO ordinal scale score of 3, 4 or 5 at baseline
4. Male or non-pregnant female adult ≥18 years of age at time of enrolment.
5. Subject (or legally authorized representative (LAR)) provides written informed consent
prior to initiation of any study procedures.
6. Understands and agrees to comply with planned study procedures.
7. Illness of any duration
8. Women of childbearing potential must have a negative blood pregnancy test at the
screening/baseline visit (Day 1) and agree to use a double method of birth control
through 30 days after the last dose of study drug.
Exclusion Criteria:
1. Intubated and mechanically ventilated at baseline
2. Receiving extracorporeal membrane oxygenation (ECMO) at baseline
3. Severe organ dysfunction (SOFA score > 10)
4. Patient or LAR unable to provide written informed consent
5. ALT/AST > 3 times the upper limit of normal or serum bilirubin > 1.5 times the upper
limit of normal
6. Estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease
(MDRD) formula < 30 mL/min/1.73 m^2 or on dialysis
7. Pregnancy or breast feeding.
8. Anticipated transfer to another hospital which is not a study site within 72 hours.
9. Allergy to any study medication