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Trial - NCT04345601


Column Value
Trial registration number NCT04345601
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04345601

First author
Last imported at : March 8, 2023, 4 a.m.
Source : ClinicalTrials.gov

LaQuisa Hill

Contact
Last imported at : March 8, 2023, 4 a.m.
Source : ClinicalTrials.gov

Not reported

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

2020-04-14

Recruitment status
Last imported at : March 8, 2023, 4 a.m.
Source : ClinicalTrials.gov

Completed

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

Open 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: 18 years or older confirmed sars-cov2 infection real-time reverse transcription polymerase chain reaction (rt-pcr) assay moderate or severe ards, based on the degree of impairment of oxygenation as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (pao2/fio2): moderate ards: pao2/fio2 100-200 mmhg or severe ards: pao2/fio2 ≤100 mmhg if on invasive or noninvasive (bipap) mechanical ventilator, peep ≥5 cm h2o bilateral opacities present on chest radiograph or computed tomographic (ct) scan, that are not fully explained by pleural effusions, lung collapse, or lung nodules.

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

currently receiving extracorporeal membrane oxygenation (ecmo) severe chronic respiratory disease requiring use of home oxygen pregnant or lactating known hypersensitivity to dimethyl sulfoxide (dmso) unstable hemodynamics (ventricular tachycardia or fibrillation) uncontrolled bacterial or fungal co-infection any end-stage organ disease or condition, which in the opinion of the investigator, makes the patient an unsuitable candidate for treatment inability to obtain informed consent (from patient or legally appropriate proxy) presence of any contraindication to receiving prophylactic low dose unfractionated or low molecular weight heparin.

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

Baylor College of Medicine

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

18

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

100

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

United States

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

Moderate/severe disease at enrollment

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

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : March 8, 2023, 4 a.m.
Source : ClinicalTrials.gov

28

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

Treatment-related serious adverse events (tSAEs);Change in clinical status at day 14

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": 793, "treatment_name": "Mesenchymal stromal cells", "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"}]