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

Starting soon · Phase 1/Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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 facts

Study ID

NCT07664696

Run by

Kimera Labs Inc.

People needed

64

Starts

2027-01-01

Expected to finish

2028-12-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subjects of either gender aged more than 18 years.
• Body Mass index (BMI) between ≥25 and ≤39.9 kg/m2.
• Duration (in days) of COVID-19 symptoms prior to randomization is a > 2 days and ≤ 10 days of COVID-19 symptoms.
• Two (2) positive (rapid) antigen diagnostic tests for SARS-CoV-2 (tests listed under FDA EUA) and administered within 2 hours of each other. Enrolled subjects will undergo subsequent molecular standard reverse transcriptase polymerase chain reaction (rt-PCR) assay. Enrolled subjects with a negative PCR test will be replaced by other individuals.)
• Subjects with a minimal baseline severity score for COVID-19-related symptoms defined as at least two symptoms with a score of 2 or higer, using normalized grading scale.
• Female subjects of non-childbearing potential (e.g., non fertile, pre-menarche, permanently sterile [e.g., underwent hysterectomy, bilateral salpingectomy or bilateral ovariectomy] or post-menopausal [history of no menses for at least 12 months without an alternative medical cause] or Woman of childbearing potential* with a negative serum or urine pregnancy test

You may not qualify if…

• Subjects who test positive for SARS-CoV-2 using a virologic test but have no symptoms consistent with COVID-19. (Asymptomatic or presymptomatic infection).
• Subjects who have SpO2 <94% on room air at sea level (Severe illness).
• Subjects who have respiratory failure (Critical illness).
• Subjects who have septic shock (Critical illness).
• Subjects who have multiple organ dysfunction (Critical illness).
• Subjects presenting with an underlying medical condition or risk factor that conclusively disposes that subject to a higher risk for progression to severe COVID-19, as per the CDC's Systematic Review Process.
• Subjects hospitalized within the previous 15 days.
• Subjects discharged from the Emergency Room within the previous 15 days.
• Subjects not expected to survive for three (3) months due to other pre-existing medical conditions such as end-stage neoplasm or other diseases.
• Less than 18 years.

Full record on ClinicalTrials.gov

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