Clinical trial NCT04389710: Convalescent Plasma for the Treatment of COVID-19
Official title: Convalescent Plasma for the Treatment of Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2
timeFrame: 1 year
Secondary outcomes:
measure: Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19
timeFrame: 0, 1, 2, 3, 7, 14 days
measure: Length of hospital stay
timeFrame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
measure: Length of Intensive Care Unit stay
timeFrame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
measure: Length of intubation
timeFrame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
measure: Survival to discharge
timeFrame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
measure: Changes in complete blood count in patients after receiving convalescent plasma
timeFrame: 0 and 7 days
measure: Abnormal changes in Basic Metabolic Panel (BMP) measures in patients after receiving convalescent plasma
timeFrame: 0 and 7 days
measure: Changes in C-Reactive Protein (CRP) in patients after receiving convalescent plasma
timeFrame: 0 and 7 days
measure: Changes in d-dimer in patients after receiving convalescent plasma
timeFrame: 0 and 7 days
measure: Changes in fibrinogen in patients after receiving convalescent plasma
timeFrame: 0 and 7 days
measure: Changes in prothrombin time (PT) in patients after receiving convalescent plasma
timeFrame: 0 and 7 days
measure: Changes in partial thromboplastin time (PTT) in patients after receiving convalescent plasma
timeFrame: 0 and 7 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References: