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).