Convalescent Plasma in the Treatment of COVID 19
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- Sponsor
- Trinity Health Of New England
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Mortality
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.
Detailed Description
The purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with COVID-19. 1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19. 2. Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All genders
- •Age \> 18 yrs and \< 90 yrs
- •Must have laboratory confirmed COVID-19
- •Must provide informed consent
- •Must have severe or immediately life-threatening COVID-19,
- •Severe disease is defined as:
- •respiratory frequency ≥ 30/min,
- •blood oxygen saturation ≤ 93%,
- •partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
- •lung infiltrates \> 50% within 24 to 48 hours
Exclusion Criteria
- •No gender exclusion
- •Age \< 18 yrs and \> 90 yrs
- •COVID-19 negative
Outcomes
Primary Outcomes
Mortality
Time Frame: Up to 28 days
Mortality within 28 days
Viral Load
Time Frame: Day 0, Day 3, Day 5, and Day 7
Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry. The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).
Serum Antibody Titers
Time Frame: Day 0, Day 3, Day 5, and Day 7
Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is \> or = 1.0 arbitrary units/mL \[AU/mL\] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)