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Covid-19Phase 2/3Inova-CCPNCT04502472

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

A Phase 2/3 study testing Convalescent plasma transfusion in people with Covid-19, run by Inova Health Care Services at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid-19
What is being tested?
Convalescent plasma transfusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
1 siteUnited States
Study dates
6 Jun 2020to 30 Sep 2020
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:

Who cannot join

  • 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.
Show all 29Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

Other trials in United States

About this study

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)

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.

Read the 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.

Conditions
Covid-19
Being tested
Convalescent plasma transfusion
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Convalescent plasma transfusionBiological

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

Study groups in NCT04502472
Study groupRoleWhat they receive
Recipient of COVID-19 Convalescent Plasma (CCP) TransfusionExperimentalPatients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria
Receives: Biological: Convalescent plasma transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change is Clinical Status

    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

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

  2. Transfusion Related Events Due to Administration of CCP

    Number of participants with Transfusion Related Adverse Events

    Measured: Within 6 hours of infusion

Secondary outcomes (5)

  1. 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:

    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

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

  2. 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)

    Measured: Total Index Hospitalization

  3. Mechanical Ventilation

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

    Measured: Days 7, 14, 21, 28

  4. Change in Mechanical Ventilation Status

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

    Measured: Day 0 (date of CCP transfusion) to Day 28

  5. Mortality

    All-cause Mortality

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2020
  2. Study start6 Jun 2020
  3. Primary completion30 Sep 2020
  4. Study completion30 Sep 2020

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04502472
Sponsor's protocol ID
Inova COVID-19 CCP
Acronym
Inova-CCP
Status last verified
Jan 2022
First submitted
4 Aug 2020
Last updated
10 Jan 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Marano G, Vaglio S, Pupella S, Facco G, Catalano L, Liumbruno GM, Grazzini G. Convalescent plasma: new evidence for an old therapeutic tool? Blood Transfus. 2016 Mar;14(2):152-7. doi: 10.2450/2015.0131-15. Epub 2015 Nov 6.

    PubMed 26674811

  • Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.

    PubMed 25030060

  • Maiztegui JI, Fernandez NJ, de Damilano AJ. Efficacy of immune plasma in treatment of Argentine haemorrhagic fever and association between treatment and a late neurological syndrome. Lancet. 1979 Dec 8;2(8154):1216-7. doi: 10.1016/s0140-6736(79)92335-3.

    PubMed 92624

  • Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8. doi: 10.1111/j.1469-0691.2004.00956.x.

    PubMed 15214887

  • Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.

    PubMed 21248066

  • Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015.

    PubMed 26618098

  • van Griensven J, Edwards T, Baize S; Ebola-Tx Consortium. Efficacy of Convalescent Plasma in Relation to Dose of Ebola Virus Antibodies. N Engl J Med. 2016 Dec 8;375(23):2307-2309. doi: 10.1056/NEJMc1609116. Epub 2016 Nov 14. No abstract available.

    PubMed 27959686

  • 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).

  • Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.

    PubMed 32113510

  • Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, Azman AS, Reich NG, Lessler J. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020 May 5;172(9):577-582. doi: 10.7326/M20-0504. Epub 2020 Mar 10.

    PubMed 32150748

  • Amanat F, Stadlbauer D, Strohmeier S, Nguyen THO, Chromikova V, McMahon M, Jiang K, Arunkumar GA, Jurczyszak D, Polanco J, Bermudez-Gonzalez M, Kleiner G, Aydillo T, Miorin L, Fierer DS, Lugo LA, Kojic EM, Stoever J, Liu STH, Cunningham-Rundles C, Felgner PL, Moran T, Garcia-Sastre A, Caplivski D, Cheng AC, Kedzierska K, Vapalahti O, Hepojoki JM, Simon V, Krammer F. A serological assay to detect SARS-CoV-2 seroconversion in humans. Nat Med. 2020 Jul;26(7):1033-1036. doi: 10.1038/s41591-020-0913-5. Epub 2020 May 12.

    PubMed 32398876

  • Epstein J, Burnouf T. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma. Vox Sang. 2020 Aug;115(6):485-487. doi: 10.1111/vox.12939. Epub 2020 May 14. No abstract available.

    PubMed 32319102

  • Beigel JH, Tebas P, Elie-Turenne MC, Bajwa E, Bell TE, Cairns CB, Shoham S, Deville JG, Feucht E, Feinberg J, Luke T, Raviprakash K, Danko J, O'Neil D, Metcalf JA, King K, Burgess TH, Aga E, Lane HC, Hughes MD, Davey RT; IRC002 Study Team. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study. Lancet Respir Med. 2017 Jun;5(6):500-511. doi: 10.1016/S2213-2600(17)30174-1. Epub 2017 May 15.

    PubMed 28522352

  • Wang Y, Fan G, Horby P, Hayden F, Li Q, Wu Q, Zou X, Li H, Zhan Q, Wang C, Cao B; CAP-China Network. Comparative Outcomes of Adults Hospitalized With Seasonal Influenza A or B Virus Infection: Application of the 7-Category Ordinal Scale. Open Forum Infect Dis. 2019 Feb 15;6(3):ofz053. doi: 10.1093/ofid/ofz053. eCollection 2019 Mar.

    PubMed 30895200

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Convalescent plasma transfusion in people with Covid-19, run by Inova Health Care Services at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change is Clinical Status (time frame: Time of plasma infusion (day 0) compared to day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04502472, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.

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