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COVID-19COV19-PLASMANCT04321421

Hyperimmune Plasma for Critical Patients With COVID-19

A study testing hyperimmune plasma in people with COVID-19, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become pandemic. To date, no specific treatment has been proven to be effective. Promising results were obtained in China using Hyperimmune plasma from patients recovered from the disease.The investigators plan to treat critical Covid-19… 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?
hyperimmune plasma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
2 sitesItaly
Study dates
17 Mar 2020to 7 May 2020
Phase
Interventional
Are there results?
None posted in the registry

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

  • age >=18 yrs
  • positive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2
  • Acute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days
  • Polymerase chain reaction (PCR) increased by 3.5 with respect to baseline or >1.8 mg/dl
  • need for mechanical ventilation or continuous positive airway pressure (CPAP)
  • signed informed consent unless unfeasible for the critical condition

Who cannot join

  • Moderate to severe ARDS lasting more than 10 days
  • proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins
  • consent denied

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Ospedale Asst Carlo Poma Mantova

    Mantua, 46100

  • Catherine Klersy

    Pavia, PV, 27100

Other trials in Italy

About this study

Official title: Plasma From Donors Recovered From New Coronavirus 2019 As Therapy For Critical Patients With Covid-19

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become pandemic. To date, no specific treatment has been proven to be effective. Promising results were obtained in China using Hyperimmune plasma from patients recovered from the disease.The investigators plan to treat critical Covid-19 patients with hyperimmune plasma.

Read the detailed description

Apheresis from recovered donors will be performed with a cell separator device , with 500-600 mL of plasma obtained from each donor. Donors are males, age 18 yrs or more, evaluated for transmissible diseases according to the italian law. Adjunctive tests will be for hepatitis A virus, hepatitis E virus and Parvovirus B-19. All donors will be tested for the Covid-19 neutralizing title. Each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately.

Based on experience published in literature 250-300 mL of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.

Conditions
COVID-19
Being tested
hyperimmune plasma
Keywords
hyperimmune plasma, COVID-19
Medical subject headings
COVID-19

What participants receive

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

  • hyperimmune plasmaOther

    administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5

Study groups in NCT04321421
Study groupRoleWhat they receive
treatedExperimentaltreated with hyperimmune plasma
Receives: Other: hyperimmune plasma

What is being measured

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

  1. death

    death from any cause

    Measured: within 7 days

Secondary outcomes (5)

  1. time to extubation

    days since intubation

    Measured: within 7 days

  2. length of intensive care unit stay

    days from entry to exit from ICU

    Measured: within 7 days

  3. time to CPAP weaning

    days since CPAP initiation

    Measured: within 7 days

  4. viral load

    naso-pharyngeal swab, sputum and BAL

    Measured: at days 1, 3 and 7

  5. immune response

    neutralizing title

    Measured: at days 1, 3 and 7

Timeline

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

  1. First posted25 Mar 2020
  2. Study start17 Mar 2020
  3. Primary completion28 Apr 2020
  4. Study completion7 May 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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Longitudinal assessment of COVID-19 patients treated with hyperimmune plasma
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04321421
Sponsor's protocol ID
IRCCSSanMatteoH
Acronym
COV19-PLASMA
Status last verified
May 2020
First submitted
23 Mar 2020
Last updated
28 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: will be decided

Publications

  • 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

  • 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 Feb 20, 2020).

  • Lai ST. Treatment of severe acute respiratory syndrome. Eur J Clin Microbiol Infect Dis. 2005 Sep;24(9):583-91. doi: 10.1007/s10096-005-0004-z.

    PubMed 16172857

  • 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 Feb 20, 2020).

  • 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

  • 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

  • Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.

    PubMed 32004427

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

    PubMed 37162745

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

    PubMed 36734509

  • Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.

    PubMed 34013969

  • Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.

    PubMed 33044747

  • Piechotta V, Chai KL, Valk SJ, Doree C, Monsef I, Wood EM, Lamikanra A, Kimber C, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Jul 10;7(7):CD013600. doi: 10.1002/14651858.CD013600.pub2.

    PubMed 32648959

  • Perotti C, Del Fante C, Baldanti F, Franchini M, Percivalle E, Vecchio Nepita E, Seminari E, De Silvestri A, Bruno R, Klersy C. Plasma from donors recovered from the new Coronavirus 2019 as therapy for critical patients with COVID-19 (COVID-19 plasma study): a multicentre study protocol. Intern Emerg Med. 2020 Aug;15(5):819-824. doi: 10.1007/s11739-020-02384-2. Epub 2020 May 28.

    PubMed 32468508

Questions about this trial

What is this clinical trial studying?

A study testing hyperimmune plasma in people with COVID-19, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.

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 6 inclusion and 3 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: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

death (time frame: within 7 days). 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 NCT04321421, which also lists 13 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 28 May 2020.

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