Safety and Efficacy of Trans Sodium Crocetinate (TSC) in SARS-CoV-2 (COVID-19) Infected Subjects

NCT04573322 | Completed Phase 1 Results DMC

• 1 other identifier: 100-303
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

SARS-CoV-2 (Covid19)

Keywords

Hypoxemia; Hypoxia

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  Lead-in phase: Overall summary of subjects with TEAEs

  Up to 70 days post-study drug administration

• Time to Recovery Through Day 28

  Lead-in phase: Time to achieve (and maintain through Day 28) a World Health Organization (WHO) ordinal COVID-19 severity scale score of 1, 2 or 3 with a minimum 1-point improvement from baseline. The scale assesses clinical status and the range is 0-8, as follows: 0\. Uninfected - No clinical or virological evidence of infection 1. Ambulatory - No limitation of activities 2. Ambulatory - Limitation of activities 3. Hospitalized, Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized, Mild Disease - Oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-low oxygen 6. Hospitalized Severe Disease - Intubation and mechanical ventilation 7. Hospitalized Severe Disease - Ventilation + additional organ support (pressors, Renal Replacement Therapy (RRT), Extracorporeal Membrane Oxygenation (ECMO) 8. Dead - Death

  28 days

Secondary Outcomes (5)

• Change From Baseline in WHO Ordinal Severity Scale as a Categorical Improvement or Worsening

  7 days

• Oxygenation - Ventilator Free Days

  28 days

• Hospital Length of Stay

  28 days

• Oxygenation - Time to Return to Baseline

  28 days

• Oxygenation - Pulse Oximetry

  Baseline through Day 10

Study Arms (6)

Lead-in 0.25 mg/kg

EXPERIMENTAL

0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days

Drug: Trans Sodium Crocetinate

Lead-in 0.50 mg/kg

EXPERIMENTAL

0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days

Drug: Trans Sodium Crocetinate

Lead-in 1.0 mg/kg

EXPERIMENTAL

1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days

Drug: Trans Sodium Crocetinate

Lead-in 1.5 mg/kg

EXPERIMENTAL

1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days

Drug: Trans Sodium Crocetinate

Randomized Active TSC

EXPERIMENTAL

TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days

Drug: Trans Sodium Crocetinate

Randomized Placebo

PLACEBO COMPARATOR

Normal Saline, in an equivalent volume by participant body weight, administered via IV bolus every 6 hours for up to 15 days

Drug: Normal saline

Interventions

Trans Sodium Crocetinate DRUG

TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days

Also known as: TSC

Lead-in 0.25 mg/kg; Lead-in 0.50 mg/kg; Lead-in 1.0 mg/kg; Lead-in 1.5 mg/kg; Randomized Active TSC

Normal saline DRUG

Normal Saline, in an equivalent volume by participant body weight, administered via IV bolus every 6 hours for up to 15 days

Also known as: 0.9% Sodium Chloride (NaCl)

Randomized Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized subjects with confirmed SARS-CoV-2 infection and hypoxemia, defined as SpO2 \< 94% on room air or requiring supplemental oxygen
• 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.
• WHO ordinal scale score of 3, 4 or 5 at baseline
• Male or non-pregnant female adult ≥18 years of age at time of enrolment.
• Subject (or legally authorized representative (LAR)) provides written informed consent prior to initiation of any study procedures.
• Understands and agrees to comply with planned study procedures.
• Illness of any duration
• 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.

You may not qualify if:

• Intubated and mechanically ventilated at baseline
• Receiving extracorporeal membrane oxygenation (ECMO) at baseline
• Severe organ dysfunction (SOFA score \> 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

Sponsors & Collaborators

• Diffusion Pharmaceuticals Inc: lead

Study Sites (1)

National Institute of Infectious Diseases- Prof. Dr. Matei Balş

Bucharest, 021105, Romania

Location

MeSH Terms

Conditions

COVID-19; Hypoxia

Interventions

trans-sodium crocetinate; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Chris Galloway, MD (Chief Medical Officer)
• Organization: Diffusion Pharmaceuticals

cgalloway@diffusionpharma.com

(434) 220-0718

Study Officials

• Adrian Streinu Cercel, MD

  National Institute of Infectious Diseases, Bucharest, Romania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Lead-in: no masking. Randomized pilot: The participants, care providers, investigators, and outcomes assessors are masked. The pharmacist, unblinded clinical research associate, and unblinded study drug administrator are not masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, pharmacokinetic, pharmacodynamic, ascending dose, safety and tolerability lead-in Single-center, randomized, placebo-controlled, double-blind, adaptive, safety and efficacy pilot

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: September 10, 2020
• Primary Completion: March 17, 2021
• Study Completion: April 29, 2021
• Last Updated: April 14, 2022
• Results First Posted: April 1, 2022

Record last verified: 2022-04

Locations

RO (1)