Coronavirus-19, Corona Virus Infection, COVID, Covid-19, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, Sars-CoV2, SARS Pneumonia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALResCure™
Patients will be treated with nebulized ResCure™
Sponsors
Rinati Skin, LLC
ProgenaBiome
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Critically ill patients with SARS from COVID-19 infection on respirators OR 2. Patients with SARS from COVID-19 infection prior or after being placed on respirator 3. Male or female patients 18 years of age and older
Exclusion criteria
1\. Patients less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of recovery of mild or moderate COVID-19 in patients using ResCure™ | 12 Weeks | Number of days from COVID-19 diagnosis to recovery via RT-PCR |
| Reduction or progression of symptomatic days | 12 Weeks | Reduction and/or progression of symptomatic days, reduction of symptom severity |
| Assess the safety of ResCure™ via pulse | 12 Weeks | Pulse from baseline to 12 weeks |
| Assess the safety of ResCure™ via oxygen saturation | 12 Weeks | Oxygen saturation from baseline to 12 weeks |
| Assess the safety of ResCure™ via EKG | 12 Weeks | EKG from baseline to 12 weeks |
| Assess Tolerability of ResCure™ | 12 Weeks | Assess Adverse Events and Serious Adverse Events due to ResCure™ |
Countries
United States
Outcome results
None listed