Purpose

This study is designed rapidly assess safety and preliminary efficacy in hospitalized patients with COVID-19 respiratory distress to provide clinical guidance for possible wider use in treating patients in this pandemic environment. This data will be used for FDA IND filings and pursuit of a BLA.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Admitted to hospital as in-patient (ward or ICU) - Respiratory distress - respiratory rate ≥ 30/minute (or PaO2:FiO2 <300) - Bilateral lung infiltrates (CT or frontal X-ray) - Supplemental oxygen started but NOT intubated or ventilated - COVID-19 (SARS-CoV-2) antigen test positive (FDA-approved test); - CDC confirmation not necessary - Time from Enrollment to treatment must be less than 24 hours - Age: 18-80 years - Gender: any - Suitability for cellular therapy: In the opinion of the Investigator or the Sponsor the patient is suitable for cellular therapy - Cognitive function: Able to understand and willing to sign informed consent form or legally authorized representative or surrogate

Exclusion Criteria

  • Intubation / ventilation - Current therapy is working, and patient is clinically improving - Disease Conditions: Heart failure severe (NY Heart Association Classification IV); Clinical evidence of left heart failure or volume overload as a primary explanation for the bilateral pulmonary infiltrates; Any disease or condition other than current respiratory COVID-19 disease for which 6-month mortality is estimated to be greater than 50%; Moderate to severe liver failure; Severe chronic respiratory disease or the use of home oxygen use prior to this current illness; Currently receiving extracorporeal life support (ECLS/ECMO) - Past Disease Conditions: Any history of malignancy within the last 2 years (except for patients in remission or cured of the malignancy); Lung transplant patient or lobectomy; Deep venous thrombosis or pulmonary embolism within past 3 months; History of splenectomy - Other Experimental Conditions: Currently enrolled or treated in last 60 days in another clinical study - Consent Issues: Do not resuscitate (DNR) order in place; Not willing to follow lung protective ventilation strategy, if needed - Concurrent disease or circumstances that Investigator or Sponsor judges to be an unacceptable risk to patient health or a confounding variable to assessment or problem in completion of trial.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
single group comparison with cohort of contemporaneous non-treated patients.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Group
This is single arm study with only comparison to non-treated cohorts at site.
  • Biological: PSC-04
    adipose stem cells derived from screened donor lipoaspirate and culture expanded.
    Other names:
    • allogeneic, adipose-derived stem cells

Recruiting Locations

More Details

NCT ID
NCT04486001
Status
Completed
Sponsor
Sorrento Therapeutics, Inc.

Detailed Description

This study is single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of PSC-04, an adipose-derived allogeneic mesenchymal stem cell. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients. Study Objectives: Primary: To evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 disease and respiratory distress. Secondary: To evaluate a set of secondary safety and efficacy outcome variables to give guidance in assessing the risk/benefit ratio in patients with COVID-19 respiratory distress.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.