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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05682560 |
|
Full text link
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
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Contact
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Sct_pCOV01@stemcyte.com.tw |
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Registration date
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
2023-01-12 |
|
Recruitment status
Last imported at : May 13, 2023, noon Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
inclusion criteria: 1. male or female aged ≥ 18 2. with post-covid syndrome 3. has had a recent (within 7 days) negative sars-cov-2 test (an approved pcr or antigen test) 4. able to provide signed informed consent (by the subject or his/her legally authorized representative) 5. is willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing a written informed consent |
|
Exclusion criteria
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
1. neurological disorders prior to covid-19 diagnosis 2. with pre-existing terminal illness 3. with known immune disease 4. is pregnant or breastfeeding 5. is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening 6. has received any vaccination within 3 weeks prior to the first ip infusion 7. judged by the investigator to be not suitable for study participation 8. under the conditions that may increase risk of complications based on the medical judgment of the investigator and the parameters |
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Number of arms
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
StemCyte, Inc. |
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Inclusion age min
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
80 |
|
Countries
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Patients recovered from covid |
|
Severity scale
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
30 |
|
primary outcome
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Treatment-emergent adverse events (TEAEs) |
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Notes
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 1334, "treatment_name": "Umbilical cord mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |