A Study of ResCure™ to Treat COVID-19 Infection

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Withdrawn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

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.

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

ArmIntervention/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

SiteCityStateCountryPostal Code
1ProgenaBiomeVenturaCaliforniaUnited States93003

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:

Study Results

No Results Posted as of Apr 8, 2021