This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.
In this Phase I open-label interventional study we will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection. Patients being treated will have severe respiratory symptoms that are at or near requiring the patient be placed on a ventilator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Patients will be treated with nebulized ResCure™
ProgenaBiome
Ventura, California, United States
The rate of recovery of mild or moderate COVID-19 in patients using ResCure™
Number of days from COVID-19 diagnosis to recovery via RT-PCR
Time frame: 12 Weeks
Reduction or progression of symptomatic days
Reduction and/or progression of symptomatic days, reduction of symptom severity
Time frame: 12 Weeks
Assess the safety of ResCure™ via pulse
Pulse from baseline to 12 weeks
Time frame: 12 Weeks
Assess the safety of ResCure™ via oxygen saturation
Oxygen saturation from baseline to 12 weeks
Time frame: 12 Weeks
Assess the safety of ResCure™ via EKG
EKG from baseline to 12 weeks
Time frame: 12 Weeks
Assess Tolerability of ResCure™
Assess Adverse Events and Serious Adverse Events due to ResCure™
Time frame: 12 Weeks
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