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A Study of ResCure™ to Treat COVID-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04395716
Recruitment Status : Not yet recruiting
First Posted : May 20, 2020
Last Update Posted : July 10, 2020
Sponsor:
Collaborator:
Rinati Skin, LLC
Information provided by (Responsible Party):
ProgenaBiome

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


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™




Primary Outcome Measures :
  1. 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

  2. Reduction or progression of symptomatic days [ Time Frame: 12 Weeks ]
    Reduction and/or progression of symptomatic days, reduction of symptom severity

  3. Assess the safety of ResCure™ via pulse [ Time Frame: 12 Weeks ]
    Pulse from baseline to 12 weeks

  4. Assess the safety of ResCure™ via oxygen saturation [ Time Frame: 12 Weeks ]
    Oxygen saturation from baseline to 12 weeks

  5. Assess the safety of ResCure™ via EKG [ Time Frame: 12 Weeks ]
    EKG from baseline to 12 weeks

  6. Assess Tolerability of ResCure™ [ Time Frame: 12 Weeks ]
    Assess Adverse Events and Serious Adverse Events due to ResCure™



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395716


Contacts
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Contact: Sabine Hazan, MD 805-339-0549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 805-339-0549 msjordandaniels@gmail.com

Locations
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United States, California
ProgenaBiome
Ventura, California, United States, 93003
Sponsors and Collaborators
ProgenaBiome
Rinati Skin, LLC
Investigators
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Principal Investigator: Sabine Hazan, MD ProgenaBiome
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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04395716    
Other Study ID Numbers: PRG-048
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases