A Study of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Post-COVID Condition

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

REGENECYTE (HPC, Cord Blood) for treatment in patients with post-COVID.

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.

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