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

June 17, 2026 updated by: Kimera Labs Inc.

A Stratified Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase I/IIa Clinical Trial to Assess the Safety and Efficacy of a Single Intravenous Dose of Isolated, Placental, Mesenchymal Stem Cell-derived Extracellular Vesicles for the Treatment of COVID-19 Symptoms in Adults With Mild to Moderate Illness

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a prospective, stratified, randomized, double-blinded, placebo-controlled, parallel-group, single-dose clinical study with the primary objective of evaluating the safety of XoGlo® PRO (isolated, placental mesenchymal stem cell [MSC]-derived extracellular vesicles [EVs]) administered intravenously (IV) for the treatment of Coronavirus Disease 2019 (COVID-19) symptoms in adults with mild-to-moderate illness. The secondary objective of the study is to evaluate the efficacy of treatment between the XoGlo® PRO treatment arm and the placebo arm.

Primary and secondary objectives will be evaluated overall and stratified by time between COVID-19 symptom onset and treatment administration (symptomatic days prior to dose), age, sex, and vaccination status.

The time from the onset of COVID-19 symptoms to single-dose treatment must be greater than 2 days but no more than 10 days. Four (4) symptom-time cohorts are defined based on the time from symptom onset to single-dose treatment administration: 3-4 days, 5-6 days, 7-8 days, and 9-10 days. Each symptom-time cohort will include 16 subjects (8 XoGlo® PRO treatment arm subjects and 8 placebo arm subjects). Vaccination status between the treatment arms and symptom-time cohorts will be balanced using stratified randomization.

As defined by the Centers for Disease Control and Prevention (CDC), vaccination status will be categorized into four groups:

Optimally Protected: A person is considered optimally protected when fully vaccinated and up to date with recommended booster doses, if eligible.

Fully Vaccinated: A person is considered fully vaccinated two weeks after receiving the second dose in a two-dose vaccine series (e.g., Pfizer-BioNTech or Moderna vaccines) or two weeks after receiving a single-dose vaccine (e.g., Johnson & Johnson/Janssen vaccine).

Partially Vaccinated: A person is considered partially vaccinated when at least two weeks have passed since receiving the first dose of a COVID-19 vaccine requiring a two-dose series.

Unvaccinated: A person is considered unvaccinated if they have not received any doses of a COVID-19 vaccine.

A subject's prior COVID-19 infection history before study participation will not be used as a randomization stratification factor. It is expected that a similar proportion of participants with prior COVID-19 infection will be distributed between treatment groups based on the prevalence of previous infection within the population. However, information regarding previous COVID-19 infection history, including date and number of prior infections, will be collected for descriptive and predictive analyses. Current active symptomatic COVID-19 infection is required for study inclusion.

Mesenchymal stem cells (MSCs) are multipotent progenitor cells with the ability to differentiate into multiple cell types. MSCs have demonstrated the capacity to modulate immune responses and support the regeneration of diseased or damaged cells and tissues in preclinical and clinical studies.

Extracellular vesicles (EVs) are naturally occurring biological messengers that contain complex cell-signaling information within extracellular nanovesicles produced by living cells. EVs produced by MSCs mimic components of the parent cell secretory profile and have been suggested to have a potential role in modulating inflammatory responses associated with viral infections, including inflammatory cytokine expression, lymphocyte activation, and signaling pathways involved in inflammation and disease progression.

Unlike live MSCs, MSC-derived EVs are acellular and have not been associated with risks related to cellular replication, malignant transformation, or graft-versus-host disease. MSC-derived EVs may also provide advantages related to manufacturing scalability, storage, and distribution.

Isolated, placental MSC-derived EVs, also known as exosomes, have been investigated for their potential role in the treatment of COVID-19 through multiple mechanisms. The protein and ribonucleic acid (RNA) contents of MSC-derived EVs contribute to their biological properties and may help modulate excessive immune responses associated with COVID-19 infection, support tissue repair mechanisms, and reduce apoptosis of alveolar epithelial cells.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult subjects of either gender aged more than 18 years.
  2. Body Mass index (BMI) between ≥25 and ≤39.9 kg/m2.
  3. Duration (in days) of COVID-19 symptoms prior to randomization is a > 2 days and ≤ 10 days of COVID-19 symptoms.
  4. 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.)
  5. 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.
  6. 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

Exclusion Criteria:

  1. Subjects who test positive for SARS-CoV-2 using a virologic test but have no symptoms consistent with COVID-19. (Asymptomatic or presymptomatic infection).
  2. Subjects who have SpO2 <94% on room air at sea level (Severe illness).
  3. Subjects who have respiratory failure (Critical illness).
  4. Subjects who have septic shock (Critical illness).
  5. Subjects who have multiple organ dysfunction (Critical illness).
  6. 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.
  7. Subjects hospitalized within the previous 15 days.
  8. Subjects discharged from the Emergency Room within the previous 15 days.
  9. Subjects not expected to survive for three (3) months due to other pre-existing medical conditions such as end-stage neoplasm or other diseases.
  10. Less than 18 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Arm
Normal Saline IV infusion
Biological: Placebo IV administration
Placebo IV infusion of normal saline
Active Comparator: Drug Product XoGlo Pro
Single IV infusion of the drug product XoGlo Pro
Biological: IV infusion using an isolated, placental, mesenchymal stem cell derived EVs
Single IV infusion of the drug product XoGlo Pro
Other Names:
  • Extracellular Vesicles
  • EVs
  • Exosome
  • XoGlo Pro

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure
Measure Description
Time Frame
Time to Resolution of COVID-19 Symptoms Following a Single Intravenous Dose of XoGlo® Pro
Time Frame: Baseline through Day 180 post-dose
Time from investigational product administration to resolution of COVID-19 symptoms as measured using the protocol-defined 14-item COVID-19 symptom assessment instrument. Symptom resolution will be assessed by comparing the time to resolution between the XoGlo® Pro treatment arm and placebo arm.
Baseline through Day 180 post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kimera Labs Inc.

Investigators

  • Study Director: Dr. Azza Halim, MD, Kimera Labs Inc. - CMO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLX-PID-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. The clinical study was not initiated, no participants were enrolled, and no individual participant data were collected. Therefore, no de-identified participant-level dataset is available for sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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