Long COVID, Post-COVID-19 Condition, Post-COVID Condition, Post-COVID Syndrome
Conditions
Keywords
Post-COVID condition, Post-COVID syndrome, Long COVID, REGENECYTE, Post-COVID fatigue, Umbilical cord blood
Brief summary
REGENECYTE (HPC, Cord Blood) for treatment in patients with post-COVID.
Detailed description
This is a two-arm, multi-center, double-blind, randomized, placebo-controlled phase III study. A total of 60 subjects with post-COVID will be enrolled.
Interventions
BIOLOGICALREGENECYTE
HPC, Cord Blood
BIOLOGICALPlacebo
Normal Saline
Sponsors
StemCyte, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged ≥ 18 * With post-COVID condition * Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or antigen test) * Able to provide signed informed consent (by the subject or his/her legally authorized representative) * 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
* Neurological disorders prior to COVID-19 diagnosis * With pre-existing terminal illness * With known immune disease * Is pregnant or breastfeeding * Is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening * Has received any vaccination within 3 weeks prior to the first IP infusion or planning to receive vaccination during the treatment period * Judged by the investigator to be not suitable for study participation, including but not limited to pre-existing chronic diseases * 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 |
|---|---|---|
| The change of efficacy | Week | Change of efficacy evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) | Week | Incidence of treatment-emergent adverse events (TEAEs) |
Contacts
Primary ContactErnest Lau, MS
Outcome results
None listed