A Study of ResCure™ to Treat COVID-19 Infection

• Sponsor: ProgenaBiome (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04395716
• Collaborator: Rinati Skin, LLC (Other)
• Enrollment: 0
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 22
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID; Covid-19; Corona Virus Infection; Sars-CoV2; Coronavirus-19; SARS Pneumonia; SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere	Biological: ResCure™	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Study of ResCure™ to Treat COVID-19 Infection
• Anticipated Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group This group will be treated with nebullized ResCure™ while hospitalized every 4 to 6 hours, depending on disease severity and ventilator status.	Biological: ResCure™; Patients will be treated with nebulized ResCure™

Outcome Measures

Primary Outcome Measures

1. 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

2. Reduction or progression of symptomatic days [12 Weeks]

   Reduction and/or progression of symptomatic days, reduction of symptom severity

3. Assess the safety of ResCure™ via pulse [12 Weeks]

   Pulse from baseline to 12 weeks

4. Assess the safety of ResCure™ via oxygen saturation [12 Weeks]

   Oxygen saturation from baseline to 12 weeks

5. Assess the safety of ResCure™ via EKG [12 Weeks]

   EKG from baseline to 12 weeks

6. Assess Tolerability of ResCure™ [12 Weeks]

   Assess Adverse Events and Serious Adverse Events due to ResCure™

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProgenaBiome	Ventura	California	United States	93003

Sponsors and Collaborators

• ProgenaBiome
• Rinati Skin, LLC

Investigators

• Principal Investigator: Sabine Hazan, MD, ProgenaBiome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ProgenaBiome
• ClinicalTrials.gov Identifier: NCT04395716
• Other Study ID Numbers: PRG-048
• First Posted: May 20, 2020
• Last Update Posted: Apr 8, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Apr 8, 2021