Status:
TERMINATED
Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma
Lead Sponsor:
Inova Health Care Services
Conditions:
Covid-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- Phase 1
- 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
- Phase 1
Exclusion
- 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
- Age ≥ 13 years
- Currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome as follows:
- Severe COVID-19: (three or more of the following)
- Dyspnea
- Respiratory rate ≥ 30/min
- Blood oxygen saturation (SpO2) ≤ 94% on room air
- Partial pressure of arterial oxygen to fraction of inspired oxygen (P:F) ratio \< 300
- Pulmonary infiltrates \> 50% of lung parenchyma within 24 to 48 hours
- Life-threatening disease is defined as: (one of the following)
- Respiratory failure
- Septic shock, and/or
- Multiple organ dysfunction or failure
- Patient must provide informed consent or have health care power of attorney/next of kin provide consent if he/she cannot.
- PHASE 2
Key Trial Info
Start Date :
June 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04502472
Start Date
June 6 2020
End Date
September 30 2020
Last Update
January 10 2022
Active Locations (1)
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1
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042