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

NCT07664696 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: KLX-PID-0001
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

COVID-19

Keywords

Exosomes; Extracellular Vesicles; EVs; Kimera

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs) Following a Single Intravenous Dose of XoGlo® Pro

  Number and percentage of participants experiencing one or more treatment-emergent adverse events (TEAEs) following administration of a single intravenous dose of XoGlo® Pro (5 mg in 5 mL). Adverse events will be assessed from the time of investigational product administration through the end of the study period.

  Baseline through 180 days post-dose

Secondary Outcomes (1)

• Time to Resolution of COVID-19 Symptoms Following a Single Intravenous Dose of XoGlo® Pro

  Baseline through Day 180 post-dose

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Normal Saline IV infusion

Biological: Placebo IV administration

Drug Product XoGlo Pro

ACTIVE COMPARATOR

Single IV infusion of the drug product XoGlo Pro

Biological: IV infusion using an isolated, placental, mesenchymal stem cell derived EVs

Interventions

Placebo IV administration BIOLOGICAL

Placebo IV infusion of normal saline

Placebo Arm

IV infusion using an isolated, placental, mesenchymal stem cell derived EVs BIOLOGICAL

Single IV infusion of the drug product XoGlo Pro

Also known as: Exosome, Extracellular Vesicles, EVs, XoGlo Pro

Drug Product XoGlo Pro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Kimera Labs Inc.: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dr. Azza Halim, MD

  Kimera Labs Inc. - CMO

  STUDY DIRECTOR

Central Study Contacts

Duncan B Ross, Ph.D.

CONTACT

305-454-7836; duncan.ross@kimeralabs.com

Jan Torres

CONTACT

305-454-7836; jan.torres@kimeralabs.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A stratified randomized, double-blind, placebo-controlled, parallel group, with randomization stratified on vaccination status, underlying medical conditions, concomitant medications, age, and sex.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share