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Trial - NCT04753476


Column Value
Trial registration number NCT04753476
Full text link
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04753476

First author
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Agung Putra, Assoc.Prof

Contact
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

dr.agungptr@gmail.com

Registration date
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-02-15

Recruitment status
Last imported at : May 8, 2023, midnight
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

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

multi-center

Study aim
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

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

inclusion criteria: patients whose clinical and laboratory test results have a positive diagnosis of covid-19. patients who are willing to participate as subjects in the study by signing the informed content. criteria for berlin to enter ards (moderate and severe) with or without a ventilator: pao2 / fio2: moderate 100-200 pao2 / fio2: severe <100 one or more comorbid history sofa score

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

the covid19 patient has fibrosis (based on the results of the chest x-ray or ct chest) ecog 4 performance status, decreased irreversible consciousness, brain stem death. severe nyha iii / iv heart failure pregnant women

Number of arms
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Stem Cell and Cancer Research Indonesia

Inclusion age min
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Inclusion age max
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Indonesia

Type of patients
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

48

primary outcome
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blood Gas Analisis (BGA);Change in patients clinical manifestation;CRP;D-dimer;Duration of using a ventilator;Length of stay;Need for a ventilator;Photo thorax;Routine blood profile

Notes
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

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

Phase 2

Arms
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1176, "treatment_name": "Secretome-mscs", "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"}]