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Purpose

This protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18 years and older - Laboratory confirmed diagnosis of SARS-CoV-2 - Admitted to an acute care facility for the treatment of COVID-19 complications - Informed consent provided by patient or legally authorized representative - Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease Severe Disease defined as any of the following - Dyspnea - Respiratory rate > 30/minute - Oxygen saturation <94% - Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300 - Lung infiltrates >50% within 24 to 48 hours Life-threatening disease defined as any of the following - Respiratory failure - Septic shock - Multiple organ dysfunction or failure • Informed consent provided by patient or healthcare proxy

Exclusion Criteria

  • Receipt of pooled immunoglobulin in past 30 days - Contraindication to transfusion or history of prior reactions to transfusion blood products

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Provide access to COVID-19 convalescent plasma for patients infected with SARS-CoV-2 currently hospitalized in acute care facilities
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention Group 		Participants included in the experimental group will receive 200-600 milliliters of convalescent plasma, administered at a rate of 100-250 mL/hr
  • Drug: Convalescent Plasma
    One to two units (200-600 mL) of ABO compatible COVID-19 convalescent plasma

Recruiting Locations

More Details

NCT ID
NCT04389710
Status
Completed
Sponsor
Thomas Jefferson University

Detailed Description

This is an open-label expanded access program to make appropriately matched convalescent plasma available for the treatment of patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. COVID-19 convalescent plasma will be obtained from the Jefferson Blood Bank and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exem ption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).

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.