COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002369-32/RO

Diffusion Pharmaceuticals Inc - Chairman and CEO

Dkalergis@diffusionpharma.com

2020-06-19

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Hospitalized subjects with confirmed SARS-CoV-2 infection and hypoxemia, defined as SpO2 < 94% on room air or requiring supplemental oxygen 2. 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. 3. WHO ordinal scale score of 3, 4 or 5 at baseline 4. Male or non-pregnant female adult ≥18 years of age at time of enrolment. 5. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 6. Understands and agrees to comply with planned study procedures. 7. Agrees to the collection of venous blood per protocol. 8. Illness of any duration 9..Women of childbearing potential must have a negative blood pregnancy test at the screening/baseline visit (Day 1) and agree to use a double method of birth control through 30 days after the last dose of study drug

1. Intubated and mechanically ventilated at baseline 2. Receiving extracorporeal membrane oxygenation (ECMO) at baseline 3. Severe organ dysfunction (SOFA score > 10) 4. Patient or LAR unable to provide written informed consent 5. ALT/AST > 5 times the upper limit of normal. 6. Stage 3 (EGFR by MDRD) severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) 7. Pregnancy or breast feeding. 8. Anticipated transfer to another hospital which is not a study site within 72 hours. 9. Allergy to any study medication 10. Moribund patient not expected to survive 24 hours

2

Diffusion Pharmaceuticals Inc.

18

100

United States

Moderate disease at enrollment

3: Moderate disease at enrollment

224

Lead-In PK/PD • Serious adverse events / Adverse events (Dose Limiting Toxicity) Randomized pilot • Time to recovery through Day 28, defined as time to achieve (and maintain through Day 28) a WHO ordinal severity scale score of 1, 2 or 3 with a minimum 1-point improvement from baseline

Declared number of arm (3.0) differs from found arms (2.0)

Phase 1/Phase 2

[{"arm_notes": "New Type treatment : N/A", "treatment_id": 1312, "treatment_name": "Trans sodium crocetinate", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]