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Completed

NCT Number: NCT04421404

Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients

The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Francisco General Hospital, San Francisco, California, United States

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About this study

A total of 50 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent fresh frozen plasma (frozen within 8 hours of collection) of PF24 (frozen within 24 hours) from blood donors who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or control (standard fresh frozen plasma collected prior to 12/1/2019 or with documented negative SARS-CoV-2 antibody). Should additional anti-COVID agents (anti-viral and/or anti-inflammatory) become available for use as standard of care during implementation, the sample size will be recalculated and increased to account for the estimated impact that these agents may have on the reducing the progression to the primary endpoint of severe hypoxemia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

for Enrollment:

  • Patients ≥18 years of age
  • Hospitalized with COVID-19
  • Enrolled within 72 hours of hospitalization OR within day 14 from first signs of illness
  • Pulmonary infiltrates on chest imaging
  • Oxygenation of <95% on room air
  • Laboratory confirmed COVID-19

Exclusion criteria

  • Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure
  • Baseline requirement for oxygen supplementation prior to COVID-19 infection or use of positive pressure therapy for sleep disordered breathing
  • Currently experiencing severe hypoxemic failure, as defined in study endpoints
  • Prior receipt of plasma products, IVIG, or hyperimmune globulin within past 3 months
  • Not currently enrolled another interventional clinical trial of COVID-19 treatment.

Note: If taking medications with potential anti-COVID activity for the purpose of COVID-19 treatment that do not yet have data to support efficacy, such as IL-6 antagonists, these medications must be stopped prior to enrollment. Receipt of current standard of care COVID-19 treatment, including remdesivir and dexamethasone is permitted and should be recorded as a concomitant medication.

Note: Pregnancy is not exclusionary but will merit additional discussion of risks & benefits in the context of ongoing pregnancy

Treatment and study plan

COVID-19 Convalescent Plasma (CCP)

Biological

COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.

Placebo

Biological

Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.

Primary outcomes

  1. Mechanical Ventilation or Death Endpoint

    Time frame: Day 14

    Number of participants that progressed to mechanical ventilation or death within the first 14 days of enrollment.

Secondary outcomes

  1. Mechanical Ventilation or Death Endpoint

    Time frame: Day 28

    Progression to mechanical ventilation or death within the first 28 days of enrollment.

  2. 8-Point Ordinal Scale Endpoint

    Time frame: Day 29

    Clinical efficacy of CCP relative to the control arm in adults hospitalized with COVID-19 according to clinical status as assessed by 8-point ordinal scale.

    8 Point WHO Ordinal Scale of Clinical Status:

    Uninfected (No clinical or virological evidence of infection) - 0

    Ambulatory (No limitation of activities) - 1 Ambulatory (Limitation of Activities) - 2

    Hospitalized Mild Disease (Hospitalized, no oxygen therapy) - 3 Hospitalized Mild Disease (Oxygen by mask or nasal prongs) - 4

    Hospitalized Severe Disease (Non-invasive ventilation or high flow oxygen) - 5 Hospitalized Severe Disease (Intubation and mechanical ventilation) - 6 Hospitalized Severe Disease (Ventilation + Additional organ support (pressors, RRT, ECMO)) - 7

    Dead (Death) - 8

Sponsors and collaborators

Lead sponsor

Priscilla Hsue, MD

Other

Collaborators

  • San Francisco General Hospital
  • Vitalant Research Institute

Registry information

Official study title

A Randomized Controlled Adaptive Study Comparing COVID-19 Convalescent Plasma (CCP) to Non-immune Plasma to Limit Coronavirus-associated Complications in Hospitalized Patients

Acronym: CAPRI

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Oct 7, 2022

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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