A Study of ResCure™ to Treat COVID-19 Infection

April 6, 2021 updated by: ProgenaBiome

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • ProgenaBiome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of recovery of mild or moderate COVID-19 in patients using ResCure™
Time Frame: 12 Weeks
Number of days from COVID-19 diagnosis to recovery via RT-PCR
12 Weeks
Reduction or progression of symptomatic days
Time Frame: 12 Weeks
Reduction and/or progression of symptomatic days, reduction of symptom severity
12 Weeks
Assess the safety of ResCure™ via pulse
Time Frame: 12 Weeks
Pulse from baseline to 12 weeks
12 Weeks
Assess the safety of ResCure™ via oxygen saturation
Time Frame: 12 Weeks
Oxygen saturation from baseline to 12 weeks
12 Weeks
Assess the safety of ResCure™ via EKG
Time Frame: 12 Weeks
EKG from baseline to 12 weeks
12 Weeks
Assess Tolerability of ResCure™
Time Frame: 12 Weeks
Assess Adverse Events and Serious Adverse Events due to ResCure™
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProgenaBiome

Collaborators

Rinati Skin, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2020

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

November 1, 2021

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (ACTUAL)

May 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRG-048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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