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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04395716
Other study ID # PRG-048
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date January 2020
Est. completion date November 2021

Study information

Verified date April 2021
Source ProgenaBiome
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2021
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
ResCure™
Patients will be treated with nebulized ResCure™

Locations

Country Name City State
United States ProgenaBiome Ventura California

Sponsors (2)

Lead Sponsor Collaborator
ProgenaBiome Rinati Skin, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 Weeks
Primary Reduction or progression of symptomatic days Reduction and/or progression of symptomatic days, reduction of symptom severity 12 Weeks
Primary Assess the safety of ResCure™ via pulse Pulse from baseline to 12 weeks 12 Weeks
Primary Assess the safety of ResCure™ via oxygen saturation Oxygen saturation from baseline to 12 weeks 12 Weeks
Primary Assess the safety of ResCure™ via EKG EKG from baseline to 12 weeks 12 Weeks
Primary Assess Tolerability of ResCure™ Assess Adverse Events and Serious Adverse Events due to ResCure™ 12 Weeks
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