Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma Collected From Individuals With Documented Infection and Recovery From COVID-19 (SARS-CoV-2)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Covid-19
- Sponsor
- Inova Health Care Services
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Change is Clinical Status
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
The investigators hypothesize that use of convalescent plasma donated from individuals recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals with active, severe COVID-19 infection.
Detailed Description
The purpose of this research study is to see if convalescent plasma is safe and effective for the treatment of patients acutely ill with COVID-19. The researchers want to confirm the right dose levels of immunoglobulins/antibodies (immune proteins) and find out what therapeutic effects plasma donated by recovered individuals has on people severely sick with COVID-19.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria for Convalescent Plasma Donors:
- •Outpatients 18 years old and older who have recovered from COVID-19:
- •Have proof of Original Positive SARS-CoV-2 NAT nasopharyngeal (NP) test result
- •Complete resolution of symptoms at least 14 days prior to donation
- •Negative SARS-CoV-2 NAT nasopharyngeal (NP) specimen at screening visit
- •Able to meet standard criteria for blood donation
- •Clinically stable based on provider assessment
Exclusion Criteria
- •Exclusion criteria:
- •Inability to complete or contraindication to donation based on Donor History -
- •Questionnaire (DHQ), FDA approved standard blood donation form
- •Hb\<13.0 g/dL for males
- •Hb\<12.5 g/dL for females
- •History of 3 more pregnancies unless HLA antibody testing is performed and deemed acceptable by director of blood donor services (to reduce risks of transfusion Related Acute Lung Injury in recipients). The presence of any transfusion transmitted diseases is based on history or test results from blood sample collected from the donor at time of plasma collection in accordance to standard practice.
- •Female subjects who are pregnant by self-report.
- •Receipt of pooled immunoglobulin in past 30 days
- •PHASE 2: Inclusion Criteria for Recipients of COVID-19 Convalescent Plasma:
- •Patients in the Inova Health System with confirmed COVID-19 by PCR testing
Outcomes
Primary Outcomes
Change is Clinical Status
Time Frame: Time of plasma infusion (day 0) compared to day 7
Change is clinical status as captured by 7-point ordinal scale to include 1. Death 2. Hospitalized, requiring mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise). 7. Not Hospitalized
Transfusion Related Events Due to Administration of CCP
Time Frame: Within 6 hours of infusion
Number of participants with Transfusion Related Adverse Events
Secondary Outcomes
- Mortality(From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation.)
- Change is Clinical Status(Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28)
- Change in Mechanical Ventilation Status(Day 0 (date of CCP transfusion) to Day 28)
- Length of Hospital Stay(Total Index Hospitalization)
- Mechanical Ventilation(Days 7, 14, 21, 28)