NCT04395716

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

1.4 years

First QC Date

May 19, 2020

Last Update Submit

April 6, 2021

Conditions

COVIDCovid-19Corona Virus InfectionSars-CoV2Coronavirus-19SARS PneumoniaSARS-Associated Coronavirus as Cause of Disease Classified Elsewhere

Outcome Measures

Primary Outcomes (6)

  • 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

    12 Weeks

  • Reduction or progression of symptomatic days

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

    12 Weeks

  • Assess the safety of ResCure™ via pulse

    Pulse from baseline to 12 weeks

    12 Weeks

  • Assess the safety of ResCure™ via oxygen saturation

    Oxygen saturation from baseline to 12 weeks

    12 Weeks

  • Assess the safety of ResCure™ via EKG

    EKG from baseline to 12 weeks

    12 Weeks

  • Assess Tolerability of ResCure™

    Assess Adverse Events and Serious Adverse Events due to ResCure™

    12 Weeks

Study Arms (1)

Treatment Group

EXPERIMENTAL

This group will be treated with nebullized ResCure™ while hospitalized every 4 to 6 hours, depending on disease severity and ventilator status.

Biological: ResCure™

Interventions

ResCure™BIOLOGICAL

Patients will be treated with nebulized ResCure™

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. Patients less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sabine Hazan, MD

    ProgenaBiome

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 20, 2020

Study Start

January 1, 2020

Primary Completion

June 1, 2021

Study Completion

November 1, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)