At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
Trans Sodium Crocetinate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Trans Sodium Crocetinate and Normal saline for SARS-CoV-2 (Covid19). Completed, enrolled 25 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2 (Covid19)
CountriesRomania
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartSep 2020
First PostedOct 2020
Primary CompletionMar 2021
Study CompletionApr 2021
TodayJul 2026
First PostedOct 5, 2020
Enrollment StartSep 10, 2020
Primary CompletionMar 17, 2021
Study CompletionApr 29, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.7 years ago
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
Normal salinedrug
Normal Saline, in an equivalent volume by participant body weight, administered via IV bolus every 6 hours for up to 15 days