Long COVID, Post COVID-19 Condition, Post-COVID Syndrome
Conditions
Keywords
Long COVID, Post-COVID Syndrome, Post-COVID condition, Umbilical cord blood, RegeneCyte
Brief summary
REGENECYTE (HPC, Cord Blood, hUCB) for treatment in patients with post-COVID.
Detailed description
This is a two-arm, single-center, single-blind, randomized, placebo-controlled phase IIa study. A total of 30 subjects with post-COVID will be enrolled.
Interventions
BIOLOGICALREGENECYTE
HPC, Cord Blood
BIOLOGICALPlacebo
Normal Saline
Sponsors
StemCyte Taiwan Co., Ltd.
StemCyte, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) | Baseline to Week 26 | Incidence of treatment-emergent adverse events (TEAEs) |
Secondary
| Measure | Time frame |
|---|---|
| Change of fatigue score as measured by CFQ-11 | Baseline, Week 6, 12, 18 and 26 |
Countries
United States
Outcome results
None listed