A Study of ResCure™ to Treat COVID-19 Infection

Phase 1

Withdrawn

• Conditions: Sars-CoV2; SARS Pneumonia; Corona Virus Infection; Covid-19; Coronavirus-19; COVID; SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
• Interventions: Biological: ResCure™

• Registration Number: NCT04395716
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-01
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-20
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08
• Primary Completion: 2021-06
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Assess the safety of ResCure™ via oxygen saturation	12 Weeks	Oxygen saturation from baseline to 12 weeks
Assess Tolerability of ResCure™	12 Weeks	Assess Adverse Events and Serious Adverse Events due to ResCure™
Reduction or progression of symptomatic days	12 Weeks	Reduction and/or progression of symptomatic days, reduction of symptom severity
Assess the safety of ResCure™ via pulse	12 Weeks	Pulse from baseline to 12 weeks
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
Assess the safety of ResCure™ via EKG	12 Weeks	EKG from baseline to 12 weeks

Trial Locations

Locations (1)

ProgenaBiome; 🇺🇸 Ventura, California, United States