MedTrace Logo

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

NCT04573322 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-04-14

Study results available
· View outcomes & findings →

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)

Interventions

DRUG

Trans Sodium Crocetinate

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

Normal saline

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

Sponsors & Collaborators

  • Diffusion Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Adrian Streinu Cercel, MD · National Institute of Infectious Diseases, Bucharest, Romania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-10
Primary Completion
2021-03-17
Completion
2021-04-29

Countries

  • Romania

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04573322 on ClinicalTrials.gov