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Trial - NCT04713878


Column Value
Trial registration number NCT04713878
Full text link
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04713878

First author
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Ayca Sultan Sahin

Contact
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-01-19

Recruitment status
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 20, 2021, 12:31 a.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 : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - aged 18-90 male or female - laboratory approve of rt-pcr (real-time reverse transcription polymerase chain reaction) with covid-19 infection - pneumonia assessed by chest radiography or computed tomography - in accordance with any of the following: 1)respiratory rate ≥ 30 times / min 2) oxygen saturation ≤ 93% 3) arterial pressure of oxygen/the fraction of inspired oxygen≤ 300mmhg, 4) pulmonary imaging of focus within 24-48 hours > 50% progression - patients who remain unresponsive to medications administered according to ministry of health guidelines - patients who receiving invasive or non-invasive mechanical ventilation therapy in intensive care

Exclusion criteria
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- pregnancy - any kind of cancer, severe liver disease - failure to provide informed consent or comply with test requirements - known allergy or hypersensitivity to mscs

Number of arms
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Kanuni Sultan Suleyman Training and Research Hospital

Inclusion age min
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

90

Countries
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Turkey

Type of patients
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

21

primary outcome
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Change of clinical symptoms;Change of clinical symptoms as respiratory distress or need for oxygen support;Change of cytokine storm parameters;Change of pulmonary functions

Notes
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

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

Not reported

Arms
Last imported at : Jan. 20, 2021, 12:31 a.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": 787, "treatment_name": "Mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 787, "treatment_name": "Mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}]