Convalescent Plasma in the Treatment of COVID 19

Phase 2

Completed

• Conditions: COVID; Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); Coronavirus
• Interventions: Biological: Convalescent Plasma

• Registration Number: NCT04343261
• Lead Sponsor: Trinity Health Of New England

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.

Study Timeline

• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-08
• Study Start: 2020-04-10
• Study First Posted: 2020-04-13
• Primary Completion: 2020-07-23
• Study Completion: 2020-08-13
• Status Verified: 2020-09
• Results First Submitted: 2020-09-01
• Results First Submitted QC: 2020-09-15
• Results First Posted: 2020-09-17
• Last Update Submitted: 2020-09-22
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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:

• dyspnea,
• 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

Life-threatening disease is defined as:

• respiratory failure,
• septic shock
• multiple organ dysfunction or failure

Exclusion Criteria

• No gender exclusion
• Age < 18 yrs and > 90 yrs
• COVID-19 negative

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COVID-19 patients treated with convalescent plasma	Convalescent Plasma	Severely ill COVID-19 patients treated with convalescent plasma

Primary Outcome Measures

Name	Time	Method
Viral Load	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	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)
Mortality	Up to 28 days	Mortality within 28 days

Trial Locations

Locations (1)

Trinity Health Of New England; 🇺🇸 Hartford, Connecticut, United States