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

Sponsor
Inova Health Care Services (Other)
Overall Status
Terminated
CT.gov ID
NCT04502472
Collaborator
(none)
109
Enrollment
1
Location
1
Arm
3.8
Actual Duration (Months)
28.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Convalescent plasma transfusion
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
109 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jun 6, 2020
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
Sep 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change is Clinical Status [Time of plasma infusion (day 0) compared to day 7]

    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

  2. Transfusion Related Events Due to Administration of CCP [Within 6 hours of infusion]

    Number of participants with Transfusion Related Adverse Events

Secondary Outcome Measures

  1. Change is Clinical Status [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: 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

  2. Length of Hospital Stay [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)

  3. Mechanical Ventilation [Days 7, 14, 21, 28]

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

  4. Change in Mechanical Ventilation Status [Day 0 (date of CCP transfusion) to Day 28]

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

  5. 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.]

    All-cause Mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inova Fairfax Medical Campus Falls Church Virginia United States 22042

Sponsors and Collaborators

  • Inova Health Care Services

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT04502472
Other Study ID Numbers:
  • Inova COVID-19 CCP
First Posted:
Aug 6, 2020
Last Update Posted:
Jan 10, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
COVID-19

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title COVID-19 Convalescent Plasma (CCP) Donors COVID-19 Convalescent Plasma (CCP Recipients)
Arm/Group Description Patients recovered from COVID-19 and donated CCP through the study. Patients who were hospitalized with COVID-19 and received CCP infusions through the study.
Period Title: Overall Study
STARTED 61 48
COMPLETED 58 45
NOT COMPLETED 3 3

Baseline Characteristics

Arm/Group Title Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion Donor of COVID-19 Convalescent Plasma (CCP) Total
Arm/Group Description Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria Convalescent plasma transfusion: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome. Patients who recovered from COVID-19 infection and test negative for COVID-19 by nasopharyngeal swab. Total of all reporting groups
Overall Participants 48 61 109
Age (Count of Participants)
<=18 years
1
2.1%
0
0%
1
0.9%
Between 18 and 65 years
31
64.6%
54
88.5%
85
78%
>=65 years
16
33.3%
7
11.5%
23
21.1%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
59
48
53
Sex: Female, Male (Count of Participants)
Female
30
62.5%
35
57.4%
65
59.6%
Male
18
37.5%
26
42.6%
44
40.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
27
56.3%
4
6.6%
31
28.4%
Not Hispanic or Latino
20
41.7%
54
88.5%
74
67.9%
Unknown or Not Reported
1
2.1%
3
4.9%
4
3.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
6
12.5%
4
6.6%
10
9.2%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
3
6.3%
1
1.6%
4
3.7%
White
12
25%
53
86.9%
65
59.6%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
27
56.3%
3
4.9%
30
27.5%
Region of Enrollment (participants) [Number]
United States
48
100%
61
100%
109
100%

Outcome Measures

1. Primary Outcome
Title Change is Clinical Status
Description 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
Time Frame Time of plasma infusion (day 0) compared to day 7

Outcome Measure Data

Analysis Population Description
Patients that were hospitalized with COVID-19 and received CCP were evaluated using the 7-point ordinal scale. The worse oxygenation status was used for day 0 and day 7.
Arm/Group Title Patients Hospitalized With COVID-19
Arm/Group Description 45 patients were hospitalized with COVID-19 and received CCP through the study.
Measure Participants 45
Average Day 1 Ordinal Scale
3.06
Average Day 7 Ordinal Scale
3.86
2. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
Transfusion related events were only measured in the convalescent plasma recipient arm. 48 patients were enrolled in the study. 45 received CCP. 3 patients received CCP through individual INDs. This outcome measure was only for patients who were hospitalized with COVID-19 and received CCP through the study.
Arm/Group Title Patients Hospitalized With COVID-19
Arm/Group Description 45 patients were hospitalized with COVID-19 and received CCP through the study.
Measure Participants 45
Count of Participants [Participants]
3
6.3%
3. Secondary Outcome
Title Change is Clinical Status
Description 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
Time Frame Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28

Outcome Measure Data

Analysis Population Description
Patients ts that were hospitalized with COVID-19 and received CCP were evaluated using the 7-point ordinal scale. The worse oxygenation status was used for days 7, 14, 21, and 28
Arm/Group Title Patients Hospitalized With COVID-19
Arm/Group Description 45 patients were hospitalized with COVID-19 and received CCP through the study.
Measure Participants 45
Ordinal Scale 2 out of 7
10
20.8%
Ordinal Scale 3 out of 7
22
45.8%
Ordinal Scale 4 out of 7
13
27.1%
Ordinal Scale 5 out of 7
0
0%
Ordinal Scale 6 out of 7
0
0%
Ordinal Scale 7 out of 7
0
0%
Ordinal Scale 1 out of 7
0
0%
Ordinal Scale 2 out of 7
11
22.9%
Ordinal Scale 3 out of 7
6
12.5%
Ordinal Scale 4 out of 7
10
20.8%
Ordinal Scale 5 out of 7
1
2.1%
Ordinal Scale 6 out of 7
0
0%
Ordinal Scale 7 out of 7
12
25%
Ordinal Scale 1 out of 7
5
10.4%
Ordinal Scale 2 out of 7
5
10.4%
Ordinal Scale 3 out of 7
3
6.3%
Ordinal Scale 4 out of 7
5
10.4%
Ordinal Scale 5 out of 7
0
0%
Ordinal Scale 6 out of 7
0
0%
Ordinal Scale 7 out of 7
21
43.8%
Ordinal Scale 1 out of 7
11
22.9%
Ordinal Scale 2 out of 7
5
10.4%
Ordinal Scale 3 out of 7
1
2.1%
Ordinal Scale 4 out of 7
3
6.3%
Ordinal Scale 5 out of 7
0
0%
Ordinal Scale 6 out of 7
0
0%
Ordinal Scale 7 out of 7
23
47.9%
Ordinal Scale 1 out of 7
13
27.1%
Ordinal Scale 2 out of 7
2
4.2%
Ordinal Scale 3 out of 7
2
4.2%
Ordinal Scale 4 out of 7
1
2.1%
Ordinal Scale 5 out of 7
0
0%
Ordinal Scale 6 out of 7
0
0%
Ordinal Scale 7 out of 7
26
54.2%
Ordinal Scale 1 out of 7
14
29.2%
4. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death
Arm/Group Title Patients Hospitalized With COVID-19
Arm/Group Description 45 patients were hospitalized with COVID-19 and received CCP through the study.
Measure Participants 45
Mean (Full Range) [days]
20
5. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
The count of participants below shows the total number of participants needing mechanical ventilation for that time point.
Arm/Group Title Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion
Arm/Group Description Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria Convalescent plasma transfusion: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.
Measure Participants 45
Patients requiring mechanical ventilation
11
22.9%
Patients not requiring mechanical ventilation
17
35.4%
Patients deceased
5
10.4%
Patients discharged
12
25%
Patients requiring mechanical ventilation
5
10.4%
Patients not requiring mechanical ventilation
8
16.7%
Patients deceased
11
22.9%
Patients discharged
21
43.8%
Patients requiring mechanical ventilation
5
10.4%
Patients not requiring mechanical ventilation
4
8.3%
Patients deceased
13
27.1%
Patients discharged
23
47.9%
Patients requiring mechanical ventilation
2
4.2%
Patients not requiring mechanical ventilation
3
6.3%
Patients deceased
14
29.2%
Patients discharged
26
54.2%
6. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Patients that were hospitalized with COVID-19 and received CCP through the study
Arm/Group Title Patients Hospitalized With COVID-19
Arm/Group Description 45 patients were analyzed
Measure Participants 45
Count of Participants [Participants]
6
12.5%
7. Secondary Outcome
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.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Patients Hospitalized With COVID-19 Patients Recovered From COVID-19
Arm/Group Description 45 patients were hospitalized with COVID-19 and received CCP through the study. patients who donated CCP
Measure Participants 45 61
Count of Participants [Participants]
14
29.2%
0
0%

Adverse Events

Time Frame Patients were monitored for up to 67 days
Adverse Event Reporting Description Only serious adverse events were recorded.
Arm/Group Title Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion
Arm/Group Description Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria Convalescent plasma transfusion: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome. Adverse Events only monitored/assessed in Convalescent Plasma Recipients.
All Cause Mortality
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion
Affected / at Risk (%) # Events
Total 14/45 (31.1%)
Serious Adverse Events
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion
Affected / at Risk (%) # Events
Total 21/45 (46.7%)
Blood and lymphatic system disorders
transfusion reaction 3/45 (6.7%) 3
Respiratory, thoracic and mediastinal disorders
Death 14/45 (31.1%) 14
Intubation 4/45 (8.9%) 4
Other (Not Including Serious) Adverse Events
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion
Affected / at Risk (%) # Events
Total 0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Anne Whitney Brown, MD
Organization Inova Health Systems
Phone 7037763067
Email anne.brown@inova.org
Responsible Party:
Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT04502472
Other Study ID Numbers:
  • Inova COVID-19 CCP
First Posted:
Aug 6, 2020
Last Update Posted:
Jan 10, 2022
Last Verified:
Jan 1, 2022