Open-label, pharmacokinetic, pharmacodynamic, ascending dose safety lead-in followed by a single-center, placebo-controlled, double-blind, adaptive, safety and efficacy, pilot study of Trans Sodium Crocetinate (TSC) in SARS-CoV-2 infected subjects

Phase 1

Active, not recruiting

• Conditions: COVID-19 infection; MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002369-32-RO
• Lead Sponsor: Diffusion Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-19
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 224

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) provides written informed consent prior to initiation of any study procedures.
6. Understands and agrees to comply with planned study procedures.
7. Agrees to the collection of venous blood per protocol.
8. Illness of any duration
9..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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

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 > 5 times the upper limit of normal.
6. Stage 3 (EGFR by MDRD) severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
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
10. Moribund patient not expected to survive 24 hours

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified