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

Jonathan Gerber

Status

Conditions: Sars-CoV2; Corona Virus Infection; COVID

Treatments: Biological: Convalescent Plasma

Study type: Expanded Access

Funder types: Other

Identifiers

NCT04445207

H000020420

Details and patient eligibility

About

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.

Full description

As individuals are exposed to pathogens, the body's immune system works to create antibodies toward those pathogens. These antibodies can be found in the plasma portion of the blood. This plasma is referred to as "Convalescent plasma" and contains these infection fighting antibodies. Through a blood donation, this convalescent plasma is collected from a recovered person and transfused to a sick patient who is still fighting the same virus. This protocol will make convalescent COVID-19 plasma available to individuals who meet the eligibility criteria described.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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:

  1. Dyspnea
  2. Respiratory frequency ≥ 30/min
  3. Blood oxygen saturation ≤ 93%
  4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
  5. Lung infiltrates > 50% within 24-48 hours

• Life-threatening COVID-19 is defined as one or more of the following:

  1. Respiratory failure
  2. Septic shock
  3. Multiple organ dysfunction or failure

Exclusion criteria

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