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

Primary Purpose

Covid-19

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Convalescent plasma transfusion

About this trial

This is an interventional treatment trial for Covid-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Inova Fairfax Medical Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion

Arm Description

Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria

Outcomes

Primary Outcome Measures

Change is Clinical Status

Change is clinical status as captured by 7-point ordinal scale to include Death Hospitalized, requiring mechanical ventilation or ECMO Hospitalized, requiring non-invasive ventilation or high flow oxygen Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise). Not Hospitalized

Transfusion Related Events Due to Administration of CCP

Number of participants with Transfusion Related Adverse Events

Secondary Outcome Measures

Change is Clinical Status

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: Death Hospitalized, requiring mechanical ventilation or ECMO Hospitalized, requiring non-invasive ventilation or high flow oxygen Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise). Not Hospitalized

Length of Hospital Stay

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)

Mechanical Ventilation

Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point.

Change in Mechanical Ventilation Status

Number of participants who required a change in the mechanical ventilation status

Mortality

All-cause Mortality

Full Information

NCT ID

NCT04502472

First Posted

August 4, 2020

Last Updated

January 5, 2022

Sponsor

Inova Health Care Services

1. Study Identification

Unique Protocol Identification Number

NCT04502472

Brief Title

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

Acronym

Inova-CCP

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Terminated

Why Stopped

FDA gave emergency use approval to COVID-19 convalescent plasma on 08/24/2020

Study Start Date

June 6, 2020 (Actual)

Primary Completion Date

September 30, 2020 (Actual)

Study Completion Date

September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inova Health Care Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Model Description

Phase 1 will be recruitment and enrollment of plasma donors. Phase 2 will be continued recruitment and enrollment of plasma donors, with the addition of recruitment and enrollment of plasma recipients.

Masking

None (Open Label)

Allocation

N/A

Enrollment

109 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion

Arm Type

Experimental

Arm Description

Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria

Intervention Type

Biological

Intervention Name(s)

Convalescent plasma transfusion

Intervention Description

Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.

Primary Outcome Measure Information:

Title

Change is Clinical Status

Description

Time Frame

Time of plasma infusion (day 0) compared to day 7

Title

Transfusion Related Events Due to Administration of CCP

Description

Number of participants with Transfusion Related Adverse Events

Time Frame

Within 6 hours of infusion

Secondary Outcome Measure Information:

Title

Change is Clinical Status

Description

Time Frame

Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28

Title

Length of Hospital Stay

Description

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)

Time Frame

Total Index Hospitalization

Title

Mechanical Ventilation

Description

Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point.

Time Frame

Days 7, 14, 21, 28

Title

Change in Mechanical Ventilation Status

Description

Number of participants who required a change in the mechanical ventilation status

Time Frame

Day 0 (date of CCP transfusion) to Day 28

Title

Mortality

Description

All-cause 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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Brown, M.D.

Organizational Affiliation

Inova Health Care Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inova Fairfax Medical Campus

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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