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| Column | Value |
|---|---|
| Trial registration number | NCT04614025 |
|
Full text link
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Christian.Putensen@ukbonn.de |
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Registration date
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-11-03 |
|
Recruitment status
Last imported at : Oct. 13, 2023, 8 a.m. Source : ClinicalTrials.gov |
Terminated |
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Study design
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
key inclusion criteria: - willing and able to provide written informed consent, or with a legal representative who can provide informed consent. - male or non-pregnant female adult 18-85 years of age at time of enrollment. - laboratory-confirmed sars-cov-2 infection as determined by pcr, in any specimen up to 21 days prior to randomization. - meets definition of ards according to berlin criteria. key |
|
Exclusion criteria
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- body weight under 55 kg (121 lbs) - serum creatinine level of over 1.5 mg/dl at time of randomization. - total bilirubin ≥2 mg/dl at time of randomization. - known allergy to any of the following: dimethyl sulfoxide (dmso), human serum albumin, bovine serum albumin. - stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization. - chronic obstructive pulmonary disease gold stage above ii. |
|
Number of arms
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Pluristem Ltd. |
|
Inclusion age min
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
85 |
|
Countries
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Germany;Israel |
|
Type of patients
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Severe/critical disease at enrollment |
|
Severity scale
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
7: Severe/critical disease at enrollment |
|
Total sample size
Last imported at : Aug. 11, 2021, 4 p.m. Source : ClinicalTrials.gov |
23 |
|
primary outcome
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Number of ventilator-free days |
|
Notes
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 786, "treatment_name": "Mesenchymal-like adherent stromal cells (plx-pad)", "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"}] |