A Pilot, Open-label, Randomised Controlled Clinical Trial to Investigate Early Efficacy of CYP-001 in Adults Admitted to Intensive Care With Respiratory Failure

Cynata Therapeutics Limited5 sites in 1 country14 target enrollmentAugust 24, 2020

ConditionsCovid19 Acute Respiratory Distress Syndrome

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Covid19
Sponsor: Cynata Therapeutics Limited
Enrollment: 14
Locations: 5
Primary Endpoint: Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a pilot, multi-centre, open-label randomised controlled study to assess the early efficacy of intravenous (IV) administration of CYP-001 in adults admitted to an intensive care unit (ICU) with respiratory failure

Detailed Description

After enrolment upon meeting eligibility criteria (D0), participants baseline data will be collected and participants will be randomised to receive either standard of care treatment only, or standard of care plus CYP-001. On D1 and D3, each participant randomised to receive CYP-001 will receive an IV infusion of 2 million Cymerus mesenchymal stem cells (MSCs)/kg of body weight (up to a maximum of 200 million cells). Participants will have further data collection throughout their ICU and hospital stay and follow up to 28 days.

Registry

clinicaltrials.gov

Start Date

August 24, 2020

End Date

May 18, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cynata Therapeutics Limited

Responsible Party

Sponsor

Eligibility Criteria

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

Exclusion Criteria

•\<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/m

Outcomes

Primary Outcomes

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

Time Frame: 7 days

Assessment of respiratory dysfunction

Secondary Outcomes

Changes in oxygenation index(28 days)
Incidence and severity of treatment-emergent adverse events(28 days)
Proportional differences between groups on the Clinical Improvement Scale(28 days)
Changes in respiratory rate(28 days)
Changes in respiratory compliance (the change in lung volume per unit change in transmural pressure gradient)(28 days)
Changes in positive end-expiratory pressure(28 days)
Changes in P/F ratio(28 days)
Change in C-reactive protein (CRP) levels(7 days)
Proportional differences between groups on the SF-36(28 days)
Proportional differences between groups on the mini mental state examination(28 days)
Ventilator-free days(28 days)