COVID-19Phase 1/2NCT07664696
Evaluation of the Safety and Efficacy of XoGlo Pro, a Placental Mesenchymal Stem Cell-derived Extracellular Vesicles in Treating COVID-19 Symptoms
A Phase 1/2 study testing IV infusion using an isolated, placental, mesenchymal stem cell derived EVs in people with COVID-19, run by Kimera Labs Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- IV infusion using an isolated, placental, mesenchymal stem cell derived EVs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- IV infusion using an isolated, placental, mesenchymal stem cell derived EVs, Placebo IV administration
- Keywords
- Exosomes, Extracellular Vesicles, EVs, Kimera
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV infusion using an isolated, placental, mesenchymal stem cell derived EVsBiological
Also called Exosome, Extracellular Vesicles, EVs, XoGlo Pro
Single IV infusion of the drug product XoGlo Pro
Placebo IV administrationBiological
Placebo IV infusion of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Normal Saline IV infusion Receives: Biological: Placebo IV administration |
| Drug Product XoGlo Pro | Active comparator | Single IV infusion of the drug product XoGlo Pro Receives: Biological: IV infusion using an isolated, placental, mesenchymal stem cell derived EVs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 180 days post-dose
Secondary outcomes (1)
Time to Resolution of COVID-19 Symptoms Following a Single Intravenous Dose of XoGlo® Pro
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.
Measured: Baseline through Day 180 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A stratified randomized, double-blind, placebo-controlled, parallel group, with randomization stratified on vaccination status, underlying medical conditions, concomitant medications, age, and sex.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kimera Labs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Azza Halim, MD, Study director, Kimera Labs Inc. - CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664696
- Sponsor's protocol ID
- KLX-PID-0001
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07664696
- Acronym / sponsor ID
- KLX-PID-0001
- Conditions
- COVID-19
- Keywords
- Exosomes, Extracellular Vesicles, EVs, Kimera
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Kimera Labs Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A stratified randomized, double-blind, placebo-controlled, parallel group, with randomization stratified on vaccination status, underlying medical conditions, concomitant medications, age, and sex.
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Biological: Placebo IV administrationNormal Saline IV infusion |
| Drug Product XoGlo Pro | Active comparator | Biological: IV infusion using an isolated, placental, mesenchymal stem cell derived EVsSingle IV infusion of the drug product XoGlo Pro |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV infusion using an isolated, placental, mesenchymal stem cell derived EVsAlso: Exosome, Extracellular Vesicles, EVs, XoGlo ProSingle IV infusion of the drug product XoGlo Pro | Biological | Drug Product XoGlo Pro |
| Placebo IV administrationPlacebo IV infusion of normal saline | Biological | Placebo Arm |
Primary outcome
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.
1 secondary outcome
Time to Resolution of COVID-19 Symptoms Following a Single Intravenous Dose of XoGlo® Pro
Time frame: Baseline through Day 180 post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Azza Halim, MD study director
Kimera Labs Inc. - CMO
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IV infusion using an isolated, placental, mesenchymal stem cell derived EVs in people with COVID-19, run by Kimera Labs Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duncan B Ross, Ph.D. (305-454-7836, duncan.ross@kimeralabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.