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Completed

NCT Number: NCT04343261

Convalescent Plasma in the Treatment of COVID 19

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.

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Key information

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) COVID Coronaviridae Infections Coronavirus Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Trinity Health Of New England

Hartford, Connecticut, 06105, United States

About this study

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.

  • Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Convalescent Plasma

Biological

treatment with 2 Units of convalescent plasma

Primary outcomes

  1. Mortality

    Time frame: Up to 28 days

    Mortality within 28 days

  2. 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).

  3. 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)

Sponsors and collaborators

Lead sponsor

Trinity Health Of New England

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2020
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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