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Trial - NCT03042143


Column Value
Trial registration number NCT03042143
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT03042143

First author
Last imported at : May 26, 2022, 10:30 a.m.
Source : ClinicalTrials.gov

Danny F McAuley, MD

Contact
Last imported at : May 26, 2022, 10:30 a.m.
Source : ClinicalTrials.gov

d.f.mcauley@qub.ac.uk

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

15/04/2020

Recruitment status
Last imported at : May 26, 2022, 10:30 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: ards as defined by the berlin definition. onset within 1 week of identified insult. within the same 24-hour time period i. hypoxic respiratory failure (pao2/ fio2 ratio ≤ 27kpa on peep ≥ 5 cmh20) ii. bilateral infiltrates on chest x-ray consistent with pulmonary oedema not explained by another pulmonary pathology iii. respiratory failure not fully explained by cardiac failure or fluid overload patient is receiving invasive mechanical ventilation covid-19 based on clinical diagnosis or pcr result or other causes of ards.

Exclusion criteria
Last imported at : May 8, 2023, midnight
Source : ClinicalTrials.gov

more than 72 hours from the onset of ards. age < 16 years. patient is known to be pregnant major trauma in the prior 3 days. presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within 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 (ecls). severe chronic liver disease with child-pugh score > 12. dnar (do not attempt resuscitation) order (excluding advance directives) in place. treatment withdrawal imminent within 24 hours. consent declined. prisoners. non-english speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available. previously enrolled in the realist trial.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Belfast Health and Social Care Trust

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

16

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United Kingdom

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : May 26, 2022, 10:30 a.m.
Source : ClinicalTrials.gov

129

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Oxygenation index (OI);Incidence of Serious Adverse Events (SAEs)

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 1/Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 602, "treatment_name": "Human umbilical cord derived cd362 enriched mscs", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]