Evaluation of the Safety and Efficacy of XoGlo Pro, a Placental Mesenchymal Stem Cell-derived Extracellular Vesicles in Treating COVID-19 Symptoms

Sponsor
Kimera Labs Inc.
Study ID
NCT07664696
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IV infusion using an isolated, placental, mesenchymal stem cell derived EVs — BIOLOGICAL
    Single IV infusion of the drug product XoGlo Pro
  • Placebo IV administration — BIOLOGICAL
    Placebo IV infusion of normal saline

Study Details

Investigational New Drug trial investigating safety as primary endpoint and clinical efficacy as secondary endpoint of placental, mesenchymal stem cell-derived extracellular vesicles for the treatment of COVID-19 symptoms in adults with mild to moderate illness.

Key Dates

First listed
Jun 24, 2026
Start date
Jan 31, 2027
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Arm
    Normal Saline IV infusion
  • Active Comparator: Drug Product XoGlo Pro
    Single IV infusion of the drug product XoGlo Pro

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs) Following a Single Intravenous Dose of XoGlo® Pro [ Time Frame: Baseline through 180 days post-dose ]

Central Contacts

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COVID-19 / long COVID trialsInfectious disease trials

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