Back to resultsA Study of ResCure™ to Treat COVID-19 Infection
Primary Purpose
COVID, Covid-19, Corona Virus Infection
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ResCure™
Sponsored by
About this trial
This is an interventional treatment trial for COVID
Eligibility Criteria
Inclusion Criteria:
- Critically ill patients with SARS from COVID-19 infection on respirators OR
- Patients with SARS from COVID-19 infection prior or after being placed on respirator
- Male or female patients 18 years of age and older
Exclusion Criteria:
1. Patients less than 18 years of age
Sites / Locations
- ProgenaBiome
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
This group will be treated with nebullized ResCure™ while hospitalized every 4 to 6 hours, depending on disease severity and ventilator status.
Outcomes
Primary Outcome Measures
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
Reduction or progression of symptomatic days
Reduction and/or progression of symptomatic days, reduction of symptom severity
Assess the safety of ResCure™ via pulse
Pulse from baseline to 12 weeks
Assess the safety of ResCure™ via oxygen saturation
Oxygen saturation from baseline to 12 weeks
Assess the safety of ResCure™ via EKG
EKG from baseline to 12 weeks
Assess Tolerability of ResCure™
Assess Adverse Events and Serious Adverse Events due to ResCure™
Secondary Outcome Measures
Full Information
NCT ID
NCT04395716
First Posted
May 19, 2020
Last Updated
April 6, 2021
Sponsor
ProgenaBiome
Collaborators
Rinati Skin, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04395716
Brief Title
A Study of ResCure™ to Treat COVID-19 Infection
Official Title
A Phase I Study of ResCure™ to Treat COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Not ever started
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProgenaBiome
Collaborators
Rinati Skin, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Covid-19, Corona Virus Infection, Sars-CoV2, Coronavirus-19, SARS Pneumonia, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
This group will be treated with nebullized ResCure™ while hospitalized every 4 to 6 hours, depending on disease severity and ventilator status.
Intervention Type
Biological
Intervention Name(s)
ResCure™
Intervention Description
Patients will be treated with nebulized ResCure™
Primary Outcome Measure Information:
Title
The rate of recovery of mild or moderate COVID-19 in patients using ResCure™
Description
Number of days from COVID-19 diagnosis to recovery via RT-PCR
Time Frame
12 Weeks
Title
Reduction or progression of symptomatic days
Description
Reduction and/or progression of symptomatic days, reduction of symptom severity
Time Frame
12 Weeks
Title
Assess the safety of ResCure™ via pulse
Description
Pulse from baseline to 12 weeks
Time Frame
12 Weeks
Title
Assess the safety of ResCure™ via oxygen saturation
Description
Oxygen saturation from baseline to 12 weeks
Time Frame
12 Weeks
Title
Assess the safety of ResCure™ via EKG
Description
EKG from baseline to 12 weeks
Time Frame
12 Weeks
Title
Assess Tolerability of ResCure™
Description
Assess Adverse Events and Serious Adverse Events due to ResCure™
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Critically ill patients with SARS from COVID-19 infection on respirators OR
Patients with SARS from COVID-19 infection prior or after being placed on respirator
Male or female patients 18 years of age and older
Exclusion Criteria:
1. Patients less than 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Hazan, MD
Organizational Affiliation
ProgenaBiome
Official's Role
Principal Investigator
Facility Information:
Facility Name
ProgenaBiome
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of ResCure™ to Treat COVID-19 Infection
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