Trials Sponsors Conditions Drugs Pricing

Conditions

SARS-CoV-2 (Covid19)

Keywords

HypoxemiaHypoxia

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

Interventions

Trans Sodium CrocetinateDrug

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/kgLead-in 0.50 mg/kgLead-in 1.0 mg/kgLead-in 1.5 mg/kgRandomized Active TSC

Normal saline

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Diffusion Pharmaceuticals Inc
Industrylead

Study Sites (1)

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

Bucharest, 021105, Romania

MeSH Terms

Conditions

COVID-19Hypoxia

Interventions

trans-sodium crocetinateSaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Results Point of Contact

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

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

Enrollment

25 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
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

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 5, 2020

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (6)

Lead-in 0.25 mg/kg

Lead-in 0.50 mg/kg

Lead-in 1.0 mg/kg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Lead-in 1.5 mg/kg

Randomized Active TSC

Randomized Placebo

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Documents

Locations