COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000612910.aspx

Prof Vineet Nayyar

Vineet.Nayyar@health.nsw.gov.au

2020-05-25

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Male or female, 18 years of age or older 2. Respiratory failure with the following signs and symptoms: P/F ratio <300 mmHg Onset within one week of insult or new or worsening respiratory symptoms. Chest imaging shows bilateral opacities, which are not fully explained by effusions, lobar/lung collapse, or nodules. 3. Respiratory failure which is not fully explained by cardiac failure or fluid overload. 4. Onset of respiratory failure (as defined in inclusion criterion 2) within the past 48 hours.

1. <18 years of age 2. Patient is known to be pregnant 3. Known active malignancy that required treatment in the last year 4. WHO (2019) Class III, IV or V pulmonary hypertension 5. Venous thromboembolism currently receiving anti-coagulation or within the past 3 months 6. Currently receiving extracorporeal life support 7. Severe chronic liver disease (Child-Pugh score >12) 8. “Do Not Attempt Resuscitation” order in place 9. Treatment withdrawal imminent within 24 hours 10. BMI > 45 kg/m2. 11. 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. 12. 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. 13. Known sensitivity to DMSO or any other component of the study treatments.

2

Cynata Therapeutics Limited

18

100

Australia

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

24

To evaluate the early efficacy of CYP-001 in adults with respiratory failure being treated in intensive care units (ICU); based on improvements in P/F ratio compared to controls. This outcome is defined as a trend in trajectory of P/F ratio between groups by day 7. P/F ratio is collected from ventilatory support data combined with arterial blood gas measures[By day 7 in the study (within days 1-7). P/F ratio will be collected as per routine standard collection of data to inform respiratory function (at least 4 hourly when relevant) plus every 15 minutes during cell adminstration and 1; 2; 3; 4 and 5 hours after];To assess the safety and tolerability of CYP-001 in adults with respiratory failure being treated in ICU measured by the incidence and severity of treatment-emergent adverse events (including events related with reactions to cryoprotectant; fever read from digital thermometer; allergy; olfactory/taste disturbances); safety laboratory evaluations (immunology screen with full blood examination) and vital signs (including significant fluctuations from clinically acceptable BP; and HR and SaO2 levels measured via pulse oximetry)[Up to day 28 in the study. On days 0-7 this will be collected routinely in standard care (at least 4-hourly) plus every 15 minutes during cell administration and 1; 2; 3; 4 and 5 hours after; then daily after day 8]

Phase 1/Phase 2

[{"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"}]