Convalescent Plasma for the Treatment of COVID-19

COVID-19 Clinical Trial

Official title:

Convalescent Plasma for the Treatment of Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04389710
• Other study ID #: 20D.379
• Status: Completed
• Phase: Phase 2
• Start date: April 15, 2020
• Est. completion date: December 7, 2020

Study information

• Verified date: June 2021
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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-exemptio n-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 7, 2020
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Convalescent Plasma
One to two units (200-600 mL) of ABO compatible COVID-19 convalescent plasma

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2	Number of patients who are consented and ultimately receive convalescent plasma transfusion.	1 year
Secondary	Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19	Adverse Events including transfusion reaction (fever, rash), transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), and transfusion infection	0, 1, 2, 3, 7, 14 days
Secondary	Length of hospital stay	Days of hospitalization	0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Secondary	Length of Intensive Care Unit stay	Days of Intensive Care Unit management	0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Secondary	Length of intubation	Days of intubation requirement	0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Secondary	Survival to discharge	Proportion of patients who are successfully discharged from acute care facility	0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Secondary	Changes in complete blood count in patients after receiving convalescent plasma	Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days
Secondary	Abnormal changes in Basic Metabolic Panel (BMP) measures in patients after receiving convalescent plasma	BMP tests include measures of glucose, calcium, sodium, potassium, bicarbonate, chloride, blood urea nitrogen, and creatinine. Changes of interest include those that are flagged as abnormal. Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days
Secondary	Changes in C-Reactive Protein (CRP) in patients after receiving convalescent plasma	Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days
Secondary	Changes in d-dimer in patients after receiving convalescent plasma	Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days
Secondary	Changes in fibrinogen in patients after receiving convalescent plasma	Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days
Secondary	Changes in prothrombin time (PT) in patients after receiving convalescent plasma	Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days
Secondary	Changes in partial thromboplastin time (PTT) in patients after receiving convalescent plasma	Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).	0 and 7 days