COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04537351

Not reported

Not reported

2020-09-03

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: male or female, 18 years of age or older respiratory failure with the following signs and symptoms: p/f ratio <300 mmhg onset within one week of a known insult or new or worsening respiratory symptoms. chest imaging shows bilateral opacities, which are not fully explained by effusions, lobar/lung collapse, or nodules. respiratory failure which is not fully explained by cardiac failure or fluid overload. onset of respiratory failure within the past 48 hours (as defined in inclusion criterion 2

- <18 years of age - patient is known to be pregnant - known active malignancy that required treatment in the last year - who class iii or iv pulmonary hypertension - venous thromboembolism currently receiving anti-coagulation or within the past 3 months - currently receiving extracorporeal life support - severe chronic liver disease (child-pugh score >12) - "do not attempt resuscitation" order in place - treatment withdrawal imminent within 24 hours - bmi > 45 kg/m2. - received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned administration of study treatment. - known positive test for human immunodeficiency virus 1 (hiv 1), hiv 2, hepatitis b virus, hepatitis c virus or any other infection which the opinion of the investigator is likely to impact on the ability of the patient to participate in the study. - known sensitivity to dimethylsulfoxide (dmso) or any other component of the study treatment.

2

Cynata Therapeutics Limited

18

100

Australia

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

14

Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups

None

Phase 1

[{"arm_notes": "", "treatment_id": 367, "treatment_name": "Cyp-001", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]