Evaluation of the Safety and Efficacy of XoGlo Pro, a Placental Mesenchymal Stem Cell-derived Ext… (NCT07664696) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Evaluation of the Safety and Efficacy of XoGlo Pro, a Placental Mesenchymal Stem Cell-derived Extracellular Vesicles in Treating COVID-19 Symptoms
64 participantsStarted 2027-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Subjects who test positive for SARS-CoV-2 using a virologic test but have no symptoms consistent with COVID-19. (Asymptomatic or presymptomatic infection).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (TEAEs) Following a Single Intravenous Dose of XoGlo® Pro
. 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.