Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma (Inova-CCP)

January 5, 2022 updated by: Inova Health Care Services

Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma Collected From Individuals With Documented Infection and Recovery From COVID-19 (SARS-CoV-2)

The investigators hypothesize that use of convalescent plasma donated from individuals recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals with active, severe COVID-19 infection.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study is to see if convalescent plasma is safe and effective for the treatment of patients acutely ill with COVID-19. The researchers want to confirm the right dose levels of immunoglobulins/antibodies (immune proteins) and find out what therapeutic effects plasma donated by recovered individuals has on people severely sick with COVID-19.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Phase 1 Inclusion Criteria:

Inclusion Criteria for Convalescent Plasma Donors:

- Outpatients 18 years old and older who have recovered from COVID-19:

  • Have proof of Original Positive SARS-CoV-2 NAT nasopharyngeal (NP) test result
  • Complete resolution of symptoms at least 14 days prior to donation
  • Negative SARS-CoV-2 NAT nasopharyngeal (NP) specimen at screening visit
  • Able to meet standard criteria for blood donation
  • Clinically stable based on provider assessment

Phase 1 Exclusion Criteria:

Exclusion criteria:

  • Inability to complete or contraindication to donation based on Donor History -
  • Questionnaire (DHQ), FDA approved standard blood donation form
  • Hb<13.0 g/dL for males
  • Hb<12.5 g/dL for females
  • History of 3 more pregnancies unless HLA antibody testing is performed and deemed acceptable by director of blood donor services (to reduce risks of transfusion Related Acute Lung Injury in recipients). The presence of any transfusion transmitted diseases is based on history or test results from blood sample collected from the donor at time of plasma collection in accordance to standard practice.
  • Female subjects who are pregnant by self-report.
  • Receipt of pooled immunoglobulin in past 30 days

PHASE 2: Inclusion Criteria for Recipients of COVID-19 Convalescent Plasma:

  • Patients in the Inova Health System with confirmed COVID-19 by PCR testing
  • Age ≥ 13 years
  • Currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome as follows:

  • Severe COVID-19: (three or more of the following)

    • Dyspnea
    • Respiratory rate ≥ 30/min
    • Blood oxygen saturation (SpO2) ≤ 94% on room air
    • Partial pressure of arterial oxygen to fraction of inspired oxygen (P:F) ratio < 300
    • Pulmonary infiltrates > 50% of lung parenchyma within 24 to 48 hours

  • Life-threatening disease is defined as: (one of the following)

    • Respiratory failure
    • Septic shock, and/or
    • Multiple organ dysfunction or failure
  • Patient must provide informed consent or have health care power of attorney/next of kin provide consent if he/she cannot.

PHASE 2 Exclusion Criteria:

  • Contraindication to receive plasma as deemed by the treating physician
  • Severe hypercoagulable state (documented in medical chart or by treating physician assessment)
  • Absolute IgA deficiency
  • Prior history of Transfusion Related Acute Lung Injury (TRALI)
  • Inability to tolerate plasma volume due to severe systolic or diastolic heart failure despite slower infusion and diuretic administration
  • Positive pregnancy test (HCG)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion
Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria
Biological: Convalescent plasma transfusion
Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change is Clinical Status
Time Frame: Time of plasma infusion (day 0) compared to day 7

Change is clinical status as captured by 7-point ordinal scale to include

  1. Death
  2. Hospitalized, requiring mechanical ventilation or ECMO
  3. Hospitalized, requiring non-invasive ventilation or high flow oxygen
  4. Hospitalized, requiring supplemental oxygen
  5. Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise)
  6. Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise).
  7. Not Hospitalized
Time of plasma infusion (day 0) compared to day 7
Transfusion Related Events Due to Administration of CCP
Time Frame: Within 6 hours of infusion
Number of participants with Transfusion Related Adverse Events
Within 6 hours of infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change is Clinical Status
Time Frame: Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28

Change in 7-point ordinal scale score from time of plasma infusion (day 0-prior to first infusion) to days 7, 14, 21, and 28.

7 point ordinal scale:

  1. Death
  2. Hospitalized, requiring mechanical ventilation or ECMO
  3. Hospitalized, requiring non-invasive ventilation or high flow oxygen
  4. Hospitalized, requiring supplemental oxygen
  5. Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise)
  6. Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise).
  7. Not Hospitalized
Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28
Length of Hospital Stay
Time Frame: Total Index Hospitalization
Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death (up to an average of 67 days)
Total Index Hospitalization
Mechanical Ventilation
Time Frame: Days 7, 14, 21, 28
Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point.
Days 7, 14, 21, 28
Change in Mechanical Ventilation Status
Time Frame: Day 0 (date of CCP transfusion) to Day 28
Number of participants who required a change in the mechanical ventilation status
Day 0 (date of CCP transfusion) to Day 28
Mortality
Time Frame: From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation.
All-cause Mortality
From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Investigators

  • Principal Investigator: Anne Brown, M.D., Inova Health Care Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 6, 2020

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

September 30, 2020

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (ACTUAL)

August 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 10, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Inova COVID-19 CCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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