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Column | Value |
---|---|
Trial registration number | NCT04366323 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
ana.cardesa@juntadeandalucia.es |
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-28 |
Recruitment status
Last imported at : April 7, 2022, 9:30 p.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 : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
multi-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: age ≥ 18 clinical diagnosis of pneumonia, severe or critical, caused by covid-19 infection life expectancy > 48 hours. commitment to use a contraceptive method of proven efficacy in both men and women during the duration of the clinical trial. |
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
coinfection with other viruses or bacteria (hiv, tuberculosis, influenza virus, adenovirus or other respiratory infections, active infection by hbv or c). history of multiple allergies, including allergy to penicillin or other blactams. pregnant and lactating women. patients with malignant tumors or hemopathies or any state of immunosuppression considered as severe. patients with autoimmune diseases. chronic heart failure with ejection fraction less than 30%. any other condition for which, in the opinion of the main investigator, the subject is considered not to be in compliance with the study. |
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 |
Andalusian Network for Design and Translation of Advanced Therapies |
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 |
80 |
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Spain |
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 : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
26 |
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate;Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate |
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": 787, "treatment_name": "Mesenchymal stem 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"}] |