Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19

NCT04445207 | Unknown

• 1 other identifier: H000020420
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.

Conditions

COVID; Sars-CoV2; Corona Virus Infection

Keywords

COVID-19; Coronavirus; Sars-CoV2

Interventions

Convalescent Plasma BIOLOGICAL

One to two 200 mL units of Convalescent plasma per infusion, up to 6 total units within a 3-week period.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 12 years of age
• Covid-19 Convalescent Plasma (CCP) treatment is in line with the patient's current goals of care (i.e. recipient cannot be DNI status)
• Laboratory confirmed diagnosis of infection with SARS-CoV-2 that is severe or life threatening OR the individual is judged by the treating provider to be at a high risk of progression to severe or life-threatening disease.
• Severe COVID-19 is defined by one or more of the following:
• Dyspnea
• Respiratory frequency ≥ 30/min
• Blood oxygen saturation ≤ 93%
• Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
• Lung infiltrates \> 50% within 24-48 hours
• Life-threatening COVID-19 is defined as one or more of the following:
• Respiratory failure
• Septic shock
• Multiple organ dysfunction or failure

You may not qualify if:

• History of prior life-threatening reactions to transfusion of blood products
• Not receiving other therapies that would preclude plasma transfusion

Sponsors & Collaborators

• Jonathan Gerber: lead

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jonathan Gerber, MD

  UMASS MEDICAL SCHOOL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 24, 2020
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

US (1)