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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04573322
Recruitment Status : Completed
First Posted : October 5, 2020
Results First Posted : April 1, 2022
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
Diffusion Pharmaceuticals Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition SARS-CoV-2 (Covid19)
Interventions Drug: Trans Sodium Crocetinate
Drug: Normal saline
Enrollment 25
Recruitment Details  
Pre-assignment Details Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
Arm/Group Title Lead-in 0.25 mg/kg Lead-in 0.50 mg/kg Lead-in 1.0 mg/kg Lead-in 1.5 mg/kg
Hide Arm/Group Description

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

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

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

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

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

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

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

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
Period Title: Overall Study
Started 6 6 7 6
Completed 5 4 5 3
Not Completed 1 2 2 3
Arm/Group Title Lead-in 0.25 mg/kg Lead-in 0.50 mg/kg Lead-in 1.0 mg/kg Lead-in 1.5 mg/kg Total
Hide Arm/Group Description

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

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

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

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

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

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

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

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

 Total of all reporting groups
Overall Number of Baseline Participants 6 6 7 6 25
Hide Baseline Analysis Population Description
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 7 participants 6 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  66.7%
3
  50.0%
7
 100.0%
5
  83.3%
19
  76.0%
>=65 years
2
  33.3%
3
  50.0%
0
   0.0%
1
  16.7%
6
  24.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 7 participants 6 participants 25 participants
51.50  (18.87) 60.83  (16.04) 54.43  (8.16) 57.50  (8.89) 56.00  (13.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 7 participants 6 participants 25 participants
Female
3
  50.0%
2
  33.3%
4
  57.1%
4
  66.7%
13
  52.0%
Male
3
  50.0%
4
  66.7%
3
  42.9%
2
  33.3%
12
  48.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 7 participants 6 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
6
 100.0%
6
 100.0%
7
 100.0%
6
 100.0%
25
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Romania Number Analyzed 6 participants 6 participants 7 participants 6 participants 25 participants
6
 100.0%
6
 100.0%
7
 100.0%
6
 100.0%
25
 100.0%
1.Primary Outcome
Title Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Hide Description Lead-in phase: Overall summary of subjects with TEAEs
Time Frame Up to 70 days post-study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lead-in 0.25 mg/kg Lead-in 0.50 mg/kg Lead-in 1.0 mg/kg Lead-in 1.5 mg/kg
Hide Arm/Group Description:

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

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

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

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

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

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

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

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
Overall Number of Participants Analyzed 6 6 7 6
Measure Type: Count of Participants
Unit of Measure: Participants
Patients with any TEAE
3
  50.0%
4
  66.7%
5
  71.4%
2
  33.3%
Patients with any Serious TEAE
1
  16.7%
1
  16.7%
0
   0.0%
0
   0.0%
Patients with any TEAE of DLT
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Patients with any TEAE Resulting in Death
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
Patients with any TEAE Leading to Study Drug Discontinuation
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
Patients with any TEAE Leading to Study Drug Interruption
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Patients with any TEAE with CTCAE Grade 3 or 4
1
  16.7%
3
  50.0%
0
   0.0%
1
  16.7%
2.Primary Outcome
Title Time to Recovery Through Day 28
Hide Description

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
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lead-in 0.25 mg/kg Lead-in 0.50 mg/kg Lead-in 1.0 mg/kg Lead-in 1.5 mg/kg
Hide Arm/Group Description:

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

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

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

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

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

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

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

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
Overall Number of Participants Analyzed 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: days
14.33  (11.54) 13.67  (8.43) 7.71  (4.31) 7.50  (1.22)
3.Secondary Outcome
Title Change From Baseline in WHO Ordinal Severity Scale as a Categorical Improvement or Worsening
Hide Description

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
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lead-in 0.25 mg/kg Lead-in 0.50 mg/kg Lead-in 1.0 mg/kg Lead-in 1.5 mg/kg
Hide Arm/Group Description:

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

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

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

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

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

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

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

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
Overall Number of Participants Analyzed 6 6 7 6
Measure Type: Count of Participants
Unit of Measure: Participants
1 Point Worse from Day 1 to Day 7
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
No Change from Day 1 to Day 7
3
  50.0%
3
  50.0%
5
  71.4%
1
  16.7%
1 Point Improvement from Day 1 to Day 7
1
  16.7%
2
  33.3%
1
  14.3%
5
  83.3%
No Data Collected on Day 7
2
  33.3%
0
   0.0%
1
  14.3%
0
   0.0%
4.Secondary Outcome
Title Oxygenation - Ventilator Free Days
Hide Description Lead-in phase: Ventilator free days in the first 28 days (to day 29).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lead-in 0.25 mg/kg Lead-in 0.50 mg/kg Lead-in 1.0 mg/kg Lead-in 1.5 mg/kg
Hide Arm/Group Description:

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

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

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

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

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

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

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

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
Overall Number of Participants Analyzed 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: days
19.7  (6.05) 16.00  (5.33) 15.43  (7.28) 19.83  (1.17)
5.Secondary Outcome
Title Hospital Length of Stay
Hide Description Lead-in phase: Days of treatment during the inpatient period
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lead-in 0.25 mg/kg Lead-in 0.50 mg/kg Lead-in 1.0 mg/kg Lead-in 1.5 mg/kg
Hide Arm/Group Description:

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

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

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

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

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

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

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

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
Overall Number of Participants Analyzed 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: days
8.67  (2.66) 9.67  (2.88) 8.57  (3.78) 8.00  (2.19)
6.Secondary Outcome
Title Oxygenation - Time to Return to Baseline
Hide Description Lead-in phase: Time to return to room air or baseline oxygen requirement
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lead-in 0.25 mg/kg Lead-in 0.50 mg/kg Lead-in 1.0 mg/kg Lead-in 1.5 mg/kg
Hide Arm/Group Description:

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

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

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

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

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

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

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

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
Overall Number of Participants Analyzed 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: days
7.50  (5.68) 18.92  (18.25) 11.79  (7.47) 5.50  (2.45)
7.Secondary Outcome
Title Oxygenation - Pulse Oximetry
Hide Description Lead-in phase: Blood oxygenation by recorded continuous pulse oximetry (SpO2:FiO2 ratio)
Time Frame Baseline through Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
There are some time points where data were not collected and, for the later timepoints, subjects discontinued.
Arm/Group Title Lead-in 0.25 mg/kg Lead-in 0.50 mg/kg Lead-in 1.0 mg/kg Lead-in 1.5 mg/kg
Hide Arm/Group Description:

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

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

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

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

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

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

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

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
Overall Number of Participants Analyzed 6 6 7 6
Mean (Standard Deviation)
Unit of Measure: SpO2:FiO2
Baseline (Pre First Dose) Number Analyzed 6 participants 6 participants 7 participants 6 participants
261.83  (73.80) 164.33  (64.91) 183.97  (41.34) 255.03  (57.54)
Day 1, Prior to Dose 1 Number Analyzed 6 participants 6 participants 7 participants 6 participants
261.83  (73.80) 164.33  (64.91) 183.97  (41.34) 255.03  (57.54)
Day 1, 1 Minute Post Dose 1 Number Analyzed 6 participants 6 participants 7 participants 6 participants
261.22  (74.87) 163.33  (61.87) 189.16  (46.07) 255.33  (57.03)
Day 1, 10 Minutes Post Dose 1 Number Analyzed 6 participants 6 participants 7 participants 6 participants
261.22  (74.90) 164.87  (63.89) 188.37  (46.00) 255.15  (55.76)
Day 1, 30 Minutes Post Dose 1 Number Analyzed 6 participants 6 participants 7 participants 6 participants
260.73  (76.50) 165.67  (63.91) 187.81  (45.89) 256.07  (56.38)
Day 1, 1.5 Hours Post Dose 1 Number Analyzed 6 participants 6 participants 7 participants 6 participants
263.22  (76.78) 164.32  (62.38) 187.89  (45.01) 255.65  (54.28)
Day 1, 3 Hours Post Dose 1 Number Analyzed 6 participants 6 participants 7 participants 6 participants
262.82  (78.20) 165.20  (62.96) 189.80  (46.50) 256.67  (55.38)
Day 1, Prior to Dose 2 Number Analyzed 6 participants 6 participants 7 participants 6 participants
252.98  (87.49) 165.35  (63.48) 188.84  (45.79) 255.95  (56.01)
Day 1, Prior to Dose 3 Number Analyzed 6 participants 6 participants 7 participants 6 participants
253.23  (89.57) 166.17  (61.57) 189.86  (43.19) 255.72  (54.41)
Day 1, Prior to Dose 4 Number Analyzed 6 participants 6 participants 7 participants 6 participants
252.47  (88.97) 165.83  (64.40) 189.40  (44.72) 255.78  (55.36)
Day 2, Prior to Dose 1 Number Analyzed 6 participants 6 participants 7 participants 6 participants
274.90  (118.47) 165.32  (63.52) 207.80  (30.76) 275.20  (51.66)
Day 2, 1 Minute Post Dose 1 Number Analyzed 6 participants 6 participants 3 participants 0 participants
270.90  (118.00) 165.98  (63.00) 202.00  (33.54)
Day 2, Prior to Dose 2 Number Analyzed 6 participants 6 participants 6 participants 6 participants
303.17  (147.94) 172.12  (93.68) 201.52  (39.10) 267.90  (58.71)
Day 2, Prior to Dose 3 Number Analyzed 6 participants 6 participants 6 participants 6 participants
300.43  (146.10) 173.68  (94.74) 204.42  (49.32) 267.57  (56.69)
Day 2, Prior to Dose 4 Number Analyzed 6 participants 6 participants 6 participants 6 participants
300.40  (147.32) 174.33  (96.09) 215.25  (39.84) 266.48  (55.31)
Day 3, Prior to Dose 1 Number Analyzed 6 participants 6 participants 6 participants 6 participants
265.12  (121.86) 174.08  (95.67) 247.23  (65.92) 270.38  (71.65)
Day 3, 1 Minute Post Dose 1 Number Analyzed 6 participants 6 participants 3 participants 0 participants
265.57  (121.88) 174.08  (95.67) 245.97  (71.98)
Day 3, Prior to Dose 2 Number Analyzed 6 participants 6 participants 6 participants 6 participants
265.47  (121.09) 174.50  (93.34) 248.12  (66.38) 271.20  (71.78)
Day 3, Prior to Dose 3 Number Analyzed 6 participants 6 participants 6 participants 6 participants
266.68  (120.38) 175.05  (95.16) 254.85  (60.32) 271.70  (72.17)
Day 3, Prior to Dose 4 Number Analyzed 6 participants 6 participants 6 participants 6 participants
260.48  (121.26) 175.18  (95.25) 259.87  (52.29) 279.78  (67.28)
Day 4, Prior to Dose 1 Number Analyzed 6 participants 6 participants 6 participants 6 participants
305.20  (147.31) 179.77  (95.57) 286.12  (95.93) 321.28  (69.97)
Day 4, Prior to Dose 2 Number Analyzed 6 participants 6 participants 6 participants 6 participants
304.03  (145.69) 176.32  (87.93) 264.70  (51.29) 322.13  (71.91)
Day 4, Prior to Dose 3 Number Analyzed 6 participants 6 participants 6 participants 6 participants
303.78  (144.73) 176.32  (87.96) 266.77  (53.24) 320.35  (70.77)
Day 4, Prior to Dose 4 Number Analyzed 6 participants 6 participants 6 participants 6 participants
303.85  (143.53) 177.28  (89.45) 302.93  (91.27) 335.45  (59.25)
Day 5, Prior to Dose 1 Number Analyzed 6 participants 6 participants 6 participants 6 participants
288.23  (151.89) 176.55  (90.15) 301.43  (91.31) 343.87  (57.80)
Day 5, Prior to Dose 2 Number Analyzed 6 participants 6 participants 6 participants 6 participants
288.03  (152.74) 175.73  (88.43) 316.25  (85.00) 344.85  (56.57)
Day 5, Prior to Dose 3 Number Analyzed 6 participants 6 participants 6 participants 6 participants
287.75  (151.69) 176.88  (89.80) 314.82  (82.17) 355.35  (63.60)
Day 5, Prior to Dose 4 Number Analyzed 6 participants 6 participants 6 participants 6 participants
288.23  (151.77) 184.67  (102.13) 297.18  (45.15) 348.40  (75.66)
Day 6, Prior to Dose 1 Number Analyzed 5 participants 6 participants 5 participants 4 participants
277.96  (175.22) 189.23  (108.10) 343.86  (68.07) 341.25  (87.32)
Day 6, Prior to Dose 2 Number Analyzed 2 participants 4 participants 5 participants 4 participants
303.55  (237.38) 232.48  (138.43) 322.44  (29.39) 340.63  (90.97)
Day 6, Prior to Dose 3 Number Analyzed 2 participants 4 participants 5 participants 4 participants
298.80  (230.66) 233.93  (140.79) 322.28  (27.37) 356.63  (111.05)
Day 6, Prior to Dose 4 Number Analyzed 2 participants 4 participants 5 participants 4 participants
301.90  (233.06) 232.73  (138.10) 343.38  (69.97) 415.68  (95.68)
Day 7, Prior to Dose 1 Number Analyzed 4 participants 6 participants 6 participants 6 participants
223.05  (99.73) 236.05  (179.16) 341.35  (67.98) 433.48  (79.04)
Day 7, Prior to Dose 2 Number Analyzed 2 participants 3 participants 4 participants 3 participants
218.85  (123.67) 232.17  (212.20) 371.78  (57.66) 402.50  (115.29)
Day 7, Prior to Dose 3 Number Analyzed 2 participants 3 participants 4 participants 3 participants
218.15  (124.66) 223.37  (217.08) 340.00  (11.55) 403.43  (113.68)
Day 7, Prior to Dose 4 Number Analyzed 2 participants 3 participants 4 participants 3 participants
219.60  (122.61) 226.13  (214.31) 401.85  (70.12) 411.63  (91.25)
Day 8, Prior to Dose 1 Number Analyzed 3 participants 5 participants 5 participants 4 participants
300.37  (164.58) 187.60  (156.67) 378.26  (85.71) 425.80  (81.80)
Day 8, Prior to Dose 2 Number Analyzed 2 participants 3 participants 3 participants 1 participants
220.30  (121.62) 233.23  (206.81) 422.60  (59.76) 306.30
Day 8, Prior to Dose 3 Number Analyzed 2 participants 3 participants 3 participants 1 participants
216.55  (122.40) 248.03  (193.52) 385.00  (75.75) 306.30
Day 8, Prior to Dose 4 Number Analyzed 2 participants 3 participants 2 participants 1 participants
219.70  (126.85) 246.00  (191.24) 410.15  (79.97) 461.90
Day 9, Prior to Dose 1 Number Analyzed 2 participants 4 participants 4 participants 1 participants
294.75  (229.60) 221.45  (166.65) 395.48  (79.54) 461.90
Day 9, Prior to Dose 2 Number Analyzed 2 participants 3 participants 2 participants 1 participants
291.25  (234.55) 248.47  (189.04) 398.35  (96.66) 457.10
Day 9, Prior to Dose 3 Number Analyzed 2 participants 2 participants 2 participants 1 participants
293.35  (231.58) 149.95  (18.88) 395.95  (93.27) 457.10
Day 9, Prior to Dose 4 Number Analyzed 2 participants 2 participants 2 participants 1 participants
291.70  (227.26) 158.10  (28.43) 471.40  (0.00) 457.10
Day 10, Prior to Dose 1 Number Analyzed 2 participants 3 participants 4 participants 1 participants
213.80  (130.81) 154.67  (23.93) 395.03  (82.81) 457.10
Day 10, Prior to Dose 2 Number Analyzed 2 participants 2 participants 2 participants 1 participants
214.50  (129.82) 159.20  (31.96) 394.30  (95.60) 452.40
Day 10, Prior to Dose 3 Number Analyzed 1 participants 2 participants 2 participants 1 participants
122.70 159.90  (30.97) 469.05  (3.32) 461.90
Day 10, Prior to Dose 4 Number Analyzed 1 participants 2 participants 2 participants 1 participants
122.70 158.50  (32.95) 469.05  (3.32) 466.70
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).
Adverse Event Reporting Description Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
 
Arm/Group Title Lead-in 0.25 mg/kg Lead-in 0.50 mg/kg Lead-in 1.0 mg/kg Lead-in 1.5 mg/kg
Hide Arm/Group Description

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

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

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

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

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

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

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

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
All-Cause Mortality
Lead-in 0.25 mg/kg Lead-in 0.50 mg/kg Lead-in 1.0 mg/kg Lead-in 1.5 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)      0/6 (0.00%)      0/7 (0.00%)      0/6 (0.00%)    
Hide Serious Adverse Events
Lead-in 0.25 mg/kg Lead-in 0.50 mg/kg Lead-in 1.0 mg/kg Lead-in 1.5 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      1/6 (16.67%)      0/7 (0.00%)      0/6 (0.00%)    
Respiratory, thoracic and mediastinal disorders         
Respiratory Failure † 1  1/6 (16.67%)  1 1/6 (16.67%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lead-in 0.25 mg/kg Lead-in 0.50 mg/kg Lead-in 1.0 mg/kg Lead-in 1.5 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/6 (50.00%)      4/6 (66.67%)      5/7 (71.43%)      2/6 (33.33%)    
Blood and lymphatic system disorders         
Coagulopathy † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Cardiac disorders         
Bradycardia † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Congestive Cardiomyopathy † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Ear and labyrinth disorders         
Excessive Cerumen Production † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea † 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Dyspepsia † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Hernial Eventration † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Hiatus Hernia † 1  1/6 (16.67%)  1 1/6 (16.67%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Nausea † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Vomiting † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
General disorders         
Non-Cardiac Chest Pain † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Oedema Peripheral † 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Hepatobiliary disorders         
Hepatic Steatosis † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Hepatocellular Injury † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations         
Clostridium Difficile Colitis † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Oral Candidiasis † 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Pneumonia Bacterial † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Respiratory Tract Infection Bacterial † 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Respiratory Tract Infection Fungal † 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Sepsis † 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Superinfection Bacterial † 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Urinary Tract Infection Fungal † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications         
Contusion † 1  0/6 (0.00%)  0 2/6 (33.33%)  2 0/7 (0.00%)  0 0/6 (0.00%)  0
Investigations         
Blood Creatinine Increased † 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Electrocardiogram QT Prolonged † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders         
Hyperglycaemia † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Hyperkalaemia † 1  0/6 (0.00%)  0 1/6 (16.67%)  2 0/7 (0.00%)  0 0/6 (0.00%)  0
Hypoalbuminaemia † 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 1/6 (16.67%)  1
Hyponatraemia † 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Oedema Peripheral † 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders         
Paraesthesia † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Psychiatric disorders         
Depression † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Insomnia † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Renal and urinary disorders         
Dysuria † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  2 0/6 (0.00%)  0
Urinary Retention † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Epistaxis † 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Interstitial Lung Disease † 1  3/6 (50.00%)  3 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Pleural Effusion † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Pulmonary Hypertension † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Respiratory Failure † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders         
Hypertension † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Hypotension † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Phlebitis † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chris Galloway, MD (Chief Medical Officer)
Organization: Diffusion Pharmaceuticals
Phone: (434) 220-0718
EMail: cgalloway@diffusionpharma.com
Layout table for additonal information
Responsible Party: Diffusion Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT04573322    
Other Study ID Numbers: 100-303
First Submitted: September 29, 2020
First Posted: October 5, 2020
Results First Submitted: March 14, 2022
Results First Posted: April 1, 2022
Last Update Posted: April 14, 2022