A Study of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Post-COVID Condition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: REGENECYTE, Placebo.
- Who it may be relevant to
- Registry conditions: Long COVID, Post-COVID-19 Condition, Post-COVID Syndrome, Post-COVID Condition. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Double-blind, Randomized, Placebo-controlled, Two-arm Phase III Study to Assess the Efficacy of Human Umbilical Cord Blood (REGENECYTE) Infusion in Reducing Fatigue in Post-COVID Condition
Overview
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
- Biological REGENECYTE
HPC, Cord Blood - Biological Placebo
Normal Saline
Primary outcome measures
- The change of efficacy [Time frame: Week]
Secondary outcome measures (1)
- Treatment-emergent adverse events (TEAEs) [Time frame: Week]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07184385 · SCUS002