A Study of ResCure™ to Treat COVID-19 Infection

Covid-19 Clinical Trial

Official title:

A Phase I Study of ResCure™ to Treat COVID-19 Infection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04395716
• Other study ID #: PRG-048
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 2020
• Est. completion date: November 2021

Study information

• Verified date: April 2021
• Source: ProgenaBiome
• Contact: n/a
• Is FDA regulated: No
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• Coronavirus-19
• COVID
• Covid-19
• Infection
• Pneumonia
• SARS Pneumonia
• SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
• Sars-CoV2
• Severe Acute Respiratory Syndrome

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