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Completed

NCT Number: NCT04355767

Convalescent Plasma in Outpatients With COVID-19

The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration.

This study will enroll adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chandler Regional Medical Center, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 infection
  • Has at least one study defined risk factor for severe COVID-19 illness
  • Clinical team deems stable for outpatient management without supplemental oxygen
  • CP available at the site at the time of enrollment
  • Duration of symptoms ≤ 7 days at ED presentation
  • Informed consent from subject

Exclusion criteria

  • Age less than 18 years
  • Prisoner or ward of the state
  • Presumed unable to complete follow-up assessments
  • Prior adverse reaction(s) from blood product transfusion
  • Receipt of any blood product within the past 120 days
  • Treating clinical team unwilling to administer 300 ml fluid
  • Enrollment in another interventional trial for COVID-19 illness

Treatment and study plan

Convalescent Plasma

Biological

SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.

Saline

Biological

Saline with multivitamin administered via intravenous (IV) infusion..

Primary outcomes

  1. Number of Patients With Disease Progression (Intention-to-treat Population)

    Time frame: 15 days

    Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.

  2. Number of Patients With Disease Progression (Per-protocol Population)

    Time frame: 15 days

    Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.

Secondary outcomes

  1. Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization

    Time frame: 30 days

    This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity.

    • 1 = Not hospitalized without limitation in activity (no symptoms)
    • 2 = Not hospitalized with limitation in activity (continued symptoms)
    • 3 = Hospitalized not on supplemental oxygen
    • 4 = Hospitalized on supplemental oxygen by mask or nasal prongs
    • 5 = Hospitalized on non-invasive ventilation or high flow nasal cannula
    • 6 = Hospitalized, intubated and mechanically ventilated
    • 7 = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy)
    • 8 = Death

  2. Number of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease Progression

    Time frame: 15 days

    Assessed on the COVID Outpatient Ordinal Outcome Scale censored at 15 days after randomization. Scale provides more granular detail for outpatients than the WHO scale (adapted from Harrell and Lindsell, 2020). Worsening of symptoms is defined as any subject admitted to the hospital (level 1), seen in the emergency room (level 2), a patient who reports increased symptoms of 2 levels on the scale over a 24 hour period, or a patient who reports increased symptoms of 1 level observed for a 48 hour period.

    COVID Outpatient Ordinal Outcomes Scale

    • 1 = patient requires care in the hospital
    • 2 = patient requires care in the emergency department or urgent care
    • 3 = patient at home with symptoms rated as moderate (defined as fever, shortness of breath, abdominal pain)
    • 4 = patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness
    • 5 = patient in their usual state of health

  3. Number of Hospital-free Days During the 30 Days Following Randomization

    Time frame: 30 days

  4. All-cause Mortality

    Time frame: Assessed at 30 days

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Medical University of South Carolina
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Strategies to Innovate EmeRgENcy Care Clinical Trials Network
  • University of Pittsburgh

Registry information

Official study title

Clinical-trial of COVID-19 Convalescent Plasma in Outpatients

Acronym: C3PO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2020
Registry last updated
Oct 19, 2021

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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