NCT04573322 is a Phase 1, PHASE2 clinical trial of Trans Sodium Crocetinate in SARS-CoV-2 (Covid19), sponsored by Diffusion Pharmaceuticals Inc.

Who is sponsoring NCT04573322?

NCT04573322 is sponsored by Diffusion Pharmaceuticals Inc.

What drugs are being tested in NCT04573322?

Interventions in NCT04573322: Trans Sodium Crocetinate, Normal saline.

What condition does NCT04573322 study?

NCT04573322 studies SARS-CoV-2 (Covid19).

Is NCT04573322 still recruiting?

NCT04573322 is currently completed. Last updated 14 April 2022.

Are results published for NCT04573322?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-04-14 · How we verify

NCT04573322

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Results posted Last updated 14 April 2022

What this trial tests

Phase 1, PHASE2 trial testing Trans Sodium Crocetinate in SARS-CoV-2 (Covid19) in 25 participants. Completed in 29 April 2021.

Timeline

10 September 2020

Primary endpoint
17 March 2021

29 April 2021

Quick facts

Lead sponsor	Diffusion Pharmaceuticals Inc
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	25
Start date	10 September 2020
Primary completion	17 March 2021
Estimated completion	29 April 2021
Sites	1 location across Romania

Drugs / interventions tested

Trans Sodium Crocetinate — full drug profile →
Normal saline

Conditions studied

SARS-CoV-2 (Covid19) — all drugs for SARS-CoV-2 (Covid19) →

Sponsor

Diffusion Pharmaceuticals Inc — full company profile →

Who can join

18 and older, any sex, with SARS-CoV-2 (Covid19). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Primary · Up to 70 days post-study drug administration

Lead-in phase: Overall summary of subjects with TEAEs

Patients with any TEAE

Group	Value	95% CI
Lead-in 0.25 mg/kg	3
Lead-in 0.50 mg/kg	4
Lead-in 1.0 mg/kg	5
Lead-in 1.5 mg/kg	2

Patients with any Serious TEAE

Group	Value	95% CI
Lead-in 0.25 mg/kg	1
Lead-in 0.50 mg/kg	1
Lead-in 1.0 mg/kg	0
Lead-in 1.5 mg/kg	0

Patients with any TEAE of DLT

Group	Value	95% CI
Lead-in 0.25 mg/kg	0
Lead-in 0.50 mg/kg	0
Lead-in 1.0 mg/kg	0
Lead-in 1.5 mg/kg	0

Patients with any TEAE Resulting in Death

Group	Value	95% CI
Lead-in 0.25 mg/kg	1
Lead-in 0.50 mg/kg	0
Lead-in 1.0 mg/kg	0
Lead-in 1.5 mg/kg	0

Patients with any TEAE Leading to Study Drug Discontinuation

Group	Value	95% CI
Lead-in 0.25 mg/kg	0
Lead-in 0.50 mg/kg	1
Lead-in 1.0 mg/kg	0
Lead-in 1.5 mg/kg	0

Patients with any TEAE Leading to Study Drug Interruption

Group	Value	95% CI
Lead-in 0.25 mg/kg	0
Lead-in 0.50 mg/kg	0
Lead-in 1.0 mg/kg	0
Lead-in 1.5 mg/kg	0

Patients with any TEAE with CTCAE Grade 3 or 4

Group	Value	95% CI
Lead-in 0.25 mg/kg	1
Lead-in 0.50 mg/kg	3
Lead-in 1.0 mg/kg	0
Lead-in 1.5 mg/kg	1

Time to Recovery Through Day 28 Primary · 28 days

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 ventilati

Group	Value	95% CI
Lead-in 0.25 mg/kg	14.33	± 11.54
Lead-in 0.50 mg/kg	13.67	± 8.43
Lead-in 1.0 mg/kg	7.71	± 4.31
Lead-in 1.5 mg/kg	7.50	± 1.22

Change From Baseline in WHO Ordinal Severity Scale as a Categorical Improvement or Worsening Secondary · 7 days

Lead-in phase: Number and percentage of patients by WHO Severity Scale change from baseline through Day 7 World Health Organization (WHO) Ordinal Severity Scale 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, no requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow O2 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death

1 Point Worse from Day 1 to Day 7

Group	Value	95% CI
Lead-in 0.25 mg/kg	0
Lead-in 0.50 mg/kg	1
Lead-in 1.0 mg/kg	0
Lead-in 1.5 mg/kg	0

No Change from Day 1 to Day 7

Group	Value	95% CI
Lead-in 0.25 mg/kg	3
Lead-in 0.50 mg/kg	3
Lead-in 1.0 mg/kg	5
Lead-in 1.5 mg/kg	1

1 Point Improvement from Day 1 to Day 7

Group	Value	95% CI
Lead-in 0.25 mg/kg	1
Lead-in 0.50 mg/kg	2
Lead-in 1.0 mg/kg	1
Lead-in 1.5 mg/kg	5

No Data Collected on Day 7

Group	Value	95% CI
Lead-in 0.25 mg/kg	2
Lead-in 0.50 mg/kg	0
Lead-in 1.0 mg/kg	1
Lead-in 1.5 mg/kg	0

Oxygenation - Ventilator Free Days Secondary · 28 days

Lead-in phase: Ventilator free days in the first 28 days (to day 29).

Group	Value	95% CI
Lead-in 0.25 mg/kg	19.7	± 6.05
Lead-in 0.50 mg/kg	16.00	± 5.33
Lead-in 1.0 mg/kg	15.43	± 7.28
Lead-in 1.5 mg/kg	19.83	± 1.17

Hospital Length of Stay Secondary · 28 days

Lead-in phase: Days of treatment during the inpatient period

Group	Value	95% CI
Lead-in 0.25 mg/kg	8.67	± 2.66
Lead-in 0.50 mg/kg	9.67	± 2.88
Lead-in 1.0 mg/kg	8.57	± 3.78
Lead-in 1.5 mg/kg	8.00	± 2.19

Oxygenation - Time to Return to Baseline Secondary · 28 days

Lead-in phase: Time to return to room air or baseline oxygen requirement

Group	Value	95% CI
Lead-in 0.25 mg/kg	7.50	± 5.68
Lead-in 0.50 mg/kg	18.92	± 18.25
Lead-in 1.0 mg/kg	11.79	± 7.47
Lead-in 1.5 mg/kg	5.50	± 2.45

Oxygenation - Pulse Oximetry Secondary · Baseline through Day 10

Lead-in phase: Blood oxygenation by recorded continuous pulse oximetry (SpO2:FiO2 ratio)

Baseline (Pre First Dose)

Group	Value	95% CI
Lead-in 0.25 mg/kg	261.83	± 73.80
Lead-in 0.50 mg/kg	164.33	± 64.91
Lead-in 1.0 mg/kg	183.97	± 41.34
Lead-in 1.5 mg/kg	255.03	± 57.54

Day 1, Prior to Dose 1

Group	Value	95% CI
Lead-in 0.25 mg/kg	261.83	± 73.80
Lead-in 0.50 mg/kg	164.33	± 64.91
Lead-in 1.0 mg/kg	183.97	± 41.34
Lead-in 1.5 mg/kg	255.03	± 57.54

Day 1, 1 Minute Post Dose 1

Group	Value	95% CI
Lead-in 0.25 mg/kg	261.22	± 74.87
Lead-in 0.50 mg/kg	163.33	± 61.87
Lead-in 1.0 mg/kg	189.16	± 46.07
Lead-in 1.5 mg/kg	255.33	± 57.03

Day 1, 10 Minutes Post Dose 1

Group	Value	95% CI
Lead-in 0.25 mg/kg	261.22	± 74.90
Lead-in 0.50 mg/kg	164.87	± 63.89
Lead-in 1.0 mg/kg	188.37	± 46.00
Lead-in 1.5 mg/kg	255.15	± 55.76

Day 1, 30 Minutes Post Dose 1

Group	Value	95% CI
Lead-in 0.25 mg/kg	260.73	± 76.50
Lead-in 0.50 mg/kg	165.67	± 63.91
Lead-in 1.0 mg/kg	187.81	± 45.89
Lead-in 1.5 mg/kg	256.07	± 56.38

Day 1, 1.5 Hours Post Dose 1

Group	Value	95% CI
Lead-in 0.25 mg/kg	263.22	± 76.78
Lead-in 0.50 mg/kg	164.32	± 62.38
Lead-in 1.0 mg/kg	187.89	± 45.01
Lead-in 1.5 mg/kg	255.65	± 54.28

Day 1, 3 Hours Post Dose 1

Group	Value	95% CI
Lead-in 0.25 mg/kg	262.82	± 78.20
Lead-in 0.50 mg/kg	165.20	± 62.96
Lead-in 1.0 mg/kg	189.80	± 46.50
Lead-in 1.5 mg/kg	256.67	± 55.38

Day 1, Prior to Dose 2

Group	Value	95% CI
Lead-in 0.25 mg/kg	252.98	± 87.49
Lead-in 0.50 mg/kg	165.35	± 63.48
Lead-in 1.0 mg/kg	188.84	± 45.79
Lead-in 1.5 mg/kg	255.95	± 56.01

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lead-in 0.25 mg/kg

Serious: 1/6 (17%)

Deaths: 1/6

Lead-in 0.50 mg/kg

Serious: 1/6 (17%)

Deaths: 0/6

Lead-in 1.0 mg/kg

Serious: 0/7 (0%)

Deaths: 0/7

Lead-in 1.5 mg/kg

Serious: 0/6 (0%)

Deaths: 0/6

Serious adverse events (1 terms)

Reaction	System	Lead-in 0.25 mg/kg	Lead-in 0.50 mg/kg	Lead-in 1.0 mg/kg	Lead-in 1.5 mg/kg
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Other adverse events (43 terms — click to expand)

Reaction	System	Lead-in 0.25 mg/kg	Lead-in 0.50 mg/kg	Lead-in 1.0 mg/kg	Lead-in 1.5 mg/kg
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—
Coagulopathy	Blood and lymphatic system disorders	—	—	—	—
Bradycardia	Cardiac disorders	—	—	—	—
Congestive Cardiomyopathy	Cardiac disorders	—	—	—	—
Excessive Cerumen Production	Ear and labyrinth disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Hernial Eventration	Gastrointestinal disorders	—	—	—	—
Hiatus Hernia	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Non-Cardiac Chest Pain	General disorders	—	—	—	—
Oedema Peripheral	General disorders	—	—	—	—
Hepatic Steatosis	Hepatobiliary disorders	—	—	—	—
Hepatocellular Injury	Hepatobiliary disorders	—	—	—	—
Clostridium Difficile Colitis	Infections and infestations	—	—	—	—
Oral Candidiasis	Infections and infestations	—	—	—	—
Pneumonia Bacterial	Infections and infestations	—	—	—	—
Respiratory Tract Infection Bacterial	Infections and infestations	—	—	—	—
Respiratory Tract Infection Fungal	Infections and infestations	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—
Superinfection Bacterial	Infections and infestations	—	—	—	—
Urinary Tract Infection Fungal	Infections and infestations	—	—	—	—
Blood Creatinine Increased	Investigations	—	—	—	—
Electrocardiogram QT Prolonged	Investigations	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—
Oedema Peripheral	Metabolism and nutrition disorders	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Dysuria	Renal and urinary disorders	—	—	—	—
Urinary Retention	Renal and urinary disorders	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Most-reported serious reactions: Respiratory Failure.

Data from ClinicalTrials.gov NCT04573322 adverse events section.

Sponsor's own description

This study will assess the safety and efficacy of TSC as a treatment for participants who are infected with SARS-CoV-2 (COVID-19).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Trans Sodium Crocetinate (TSC) to Improve Oxygenation in COVID-19
Streinu-Cercel A, Săndulescu O, Miron VD, Oană A, et al · · 2021 · cited 1× · DOI 10.1101/2021.10.08.21264719

Verify or expand the search:

Other trials of Trans Sodium Crocetinate

Trials testing the same drug.

NCT05079126 — Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease · Phase 2 · terminated
NCT05036980 — Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercisi · Phase 1 · completed

Other Diffusion Pharmaceuticals Inc trials

Trials by the same sponsor.

NCT05079126 — Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease · Phase 2 · terminated
NCT05036980 — Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercisi · Phase 1 · completed
NCT04808622 — Safety and Efficacy of Trans Sodium Crocetinate (TSC) in Enhancing Tissue Oxygen Levels in Healthy Volunteers · Phase 1 · completed
NCT03763929 — Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke · Phase 2 · terminated
NCT03393000 — Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04573322 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Diffusion Pharmaceuticals Inc
Last refreshed: 14 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04573322.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing