| Trial registration number
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NCT05122234 |
Full text link
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05122234
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First author
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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Murdani Abdullah
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Contact
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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2021-11-16
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Recruitment status
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
all individuals aged 18 to 65 years
it has been confirmed positive for covid-19 by throat swab / sputum / brochoalveolar lavage (bal) with real-time reverse transcription polymerase chain reaction (rt-pcr)
categorized as a severe case of covid-19 patient
agree to participate and sign the informed consent
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Exclusion criteria
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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history of allergy to penicillin, streptomycin, and amphotericin-b
have any cancer conditions
active in other intervention studies
have had other intervention studies in the last 3 months
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Number of arms
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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Indonesia University
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Inclusion age min
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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65
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Countries
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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Indonesia
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Type of patients
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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Severe disease at enrollment
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Severity scale
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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6: Severe disease at enrollment
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Total sample size
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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40
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primary outcome
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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Assessment of inflamation marker levels
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Notes
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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Phase 3
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Arms
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1176, "treatment_name": "Secretome-mscs", "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"}]
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