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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04502472
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services

Brief Summary:
We 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
Covid-19 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 like you has on people severely sick with COVID-19.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label 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 : June 6, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. Transfusion related events [ Time Frame: Within 6 hours of infusion ]
    Presence of any adverse events related to plasma infusion


Secondary Outcome Measures :
  1. Change is clinical status [ Time Frame: Time of plasma infusion (day 0 prior to first infusion) to days 14, 21, and 28 ]
    Change in 7-point ordinal scale score from time of plasma infusion (day 0-prior to first infusion) to days 14, 21, and 28

  2. SOFA score at days 0, 7, 14, 21, 28 [ Time Frame: Days 0, 7, 14, 21, 28 ]
    Assess change in Sequential Organ Failure Assessment (SOFA) score

  3. Length of Hospital Stay [ Time Frame: Days 7, 14, 21, 28 ]
    Total duration of hospital

  4. Supplemental oxygen [ Time Frame: Days 7, 14, 21, 28 ]
    Time to discontinuation of supplemental oxygen

  5. Mechanical Ventilation [ Time Frame: Days 7, 14, 21, 28 ]
    Need for mechanical ventilation (for those patients not on the ventilator)

  6. Change in mechanical ventilation status [ Time Frame: Days 7, 14, 21, 28 ]
    Time to liberation from mechanical ventilation (for patients on a ventilator)

  7. Mortality [ Time Frame: Day 28 ]
    All-cause Mortality

  8. Change in inflammatory markers [ Time Frame: Day 0 to days 7, 14, 21, 28 ]
    Change in standard of care inflammatory markers (ferritin, LDH, CRP, D-dimer)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04502472


Contacts
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Contact: Merte Lemme-Woldehanna, BS 703-776-2020 Merte.LemmaWoldeHanna@inova.org
Contact: Edwinia Battle, BSN 703-776-3067 edwinia.battle@inova.org

Locations
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United States, Virginia
Inova Fairfax Medical Campus Recruiting
Falls Church, Virginia, United States, 22042
Contact: Merte Lemma-Woldehanna, BS       edwinia.battle@inova.org   
Contact: Edwinia Battle, BSN       edwinia.battle@inova.org   
Principal Investigator: Anne W Brown, MD         
Sponsors and Collaborators
Inova Health Care Services
Investigators
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Principal Investigator: Anne Brown, M.D. Inova Health System
Publications:
WHO. Use of convalescent whole blood or plasma collected from patients recovered from Ebola virus disease for transfusion, as an empirical treatment during outbreaks. 2014 http://apps.who.int/iris/rest/bitstreams/604045/retrieve (accessed 3/27/2020).
WHO. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected 2020. https://www.who.int/docs/default-source/coronaviruse/clinical-management-of-novel-cov.pdf (accessed 3/27/20).
Amanat F, Nguyen T, Chromikova V, et al. A serological assay to detect SARS-CoV-2 seroconversion in humans. BMJ Yale 2020. https://doi.org/10.1101/2020.03.17.20037713
Woelfel R, Corman VM, Guggemos W, et al. Clinical presentation and virological assessment of hospitalized cases of coronavirus disease 2019 in a travel-associated transmission cluster. BMJ Yale 2020. https://doi.org/10.1101/2020.03.05.20030502

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Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT04502472    
Other Study ID Numbers: Inova COVID-19 CCP
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases