Convalescent Plasma in the Treatment of COVID 19

Trinity Health Of New England

Status and phase: Completed; Phase 2

Conditions: COVID; Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); Coronavirus

Treatments: Biological: Convalescent Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04343261

SFH-20-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

COVID-19 patients treated with convalescent plasma

Experimental group

Description:

Severely ill COVID-19 patients treated with convalescent plasma

Treatment:

Biological: Convalescent Plasma