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.
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 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).
Parallel
IV infusion using an isolated, placental, mesenchymal stem cell derived EVs
Biological/VaccineSingle IV infusion of the drug product XoGlo Pro
Placebo IV administration
Biological/VaccinePlacebo IV infusion of normal saline
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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
