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Trial - NCT05132972


Column Value
Trial registration number NCT05132972
Full text link
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05132972

First author
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

Bintang Soetjahjo, MD PhD

Contact
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

bjortho@yahoo.com

Registration date
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

2021-11-24

Recruitment status
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

Blind label

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

multi-center

Study aim
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

inclusion criteria: man or woman age 18-75 years sars-cov2 positive as confirmed by sars-cov2 rt-pcr test diagnosed with pnumonia as confirmed by chect radiography and history of fever, coug with one of the following symptoms: rr > 30x per minute, sao2 93%, fao2/fio2 300 mmhg voluntarily joined the clinical trial and has signed the informed consent form

Exclusion criteria
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

pregnant and lactating woman patient who are diagnosed or have history of tumor and cancer patient whose mother or sister are diagnosed with breast or ovarian cancer level of sgpt/alt is ≥ 5 times upper limit from normal value level of egfr is < 30 ml/min reluctant to sign informed consent and unwilling to take the required tests require invasive ventilation shock organ failure currently involve in other clinical trial, or join another clinical trial in the last 3 months

Number of arms
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

Inclusion age min
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

75

Countries
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

Indonesia

Type of patients
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

42

primary outcome
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

Duration of hospital stay

Notes
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1334, "treatment_name": "Umbilical cord mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]