A Phase II Randomized, double-blind, Placebo-controlled Study to Evaluate the safety and efficacy of exosomes overexpressing CD24 to prevent clinical deterioration .The study population will include patients with moderate or severe COVID-19 infection and laboratory markers predictive of the cytokine storm from the Corona department of each site, who have provided an informed consent. 155 patients will be randomized in a 2:1 ratio to receive either 1010 exosome particles (103 patients) or placebo (52 patients).The exosomes will be diluted in 4ml normal saline for inhalation, administered once daily (QD) for 5 days. Placebo (saline) will be prepared for inhalation and administered in the same manner as the exosomes.
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To evaluate the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 disease
Timeframe: One year
To assess the efficacy of EXO-CD24 in the clinical improvement of COVID-19 disease
Timeframe: One year
To evaluate respiratory failure (defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high-flow oxygen devices) rate.
Timeframe: One year
To evaluate the death rate.
Timeframe: One year
To evaluate time to improvement and recovery (COVID-19 clinical severity score of 3 or lower).
Timeframe: One year
To evaluate time from hospitalization to hospital discharge.
Timeframe: One year
To assess the COVID-19-related symptoms using patient-reported outcome measure (PRO) score.
Timeframe: One year