NCT04321421

Brief 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 patients with hyperimmune plasma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2020

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

March 23, 2020

Last Update Submit

May 27, 2020

Conditions

COVID-19

Keywords

hyperimmune plasmaCOVID-19

Outcome Measures

Primary Outcomes (1)

  • death

    death from any cause

    within 7 days

Secondary Outcomes (5)

  • time to extubation

    within 7 days

  • length of intensive care unit stay

    within 7 days

  • time to CPAP weaning

    within 7 days

  • viral load

    at days 1, 3 and 7

  • immune response

    at days 1, 3 and 7

Study Arms (1)

treated

EXPERIMENTAL

treated with hyperimmune plasma

Other: hyperimmune plasma

Interventions

hyperimmune plasmaOTHER

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

treated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Catherine Klersy

Pavia, PV, 27100, Italy

Location

Ospedale Asst Carlo Poma Mantova

Mantova, 46100, Italy

Location

Related Publications (13)

  • 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.

    PMID: 32113510BACKGROUND

  • 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).

    BACKGROUND

  • 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.

    PMID: 16172857BACKGROUND

  • 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).

    BACKGROUND

  • 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.

    PMID: 26618098BACKGROUND

  • 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.

    PMID: 21248066BACKGROUND

  • 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.

    PMID: 32004427BACKGROUND

  • 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.

    PMID: 37162745DERIVED

  • 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.

    PMID: 36734509DERIVED

  • 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.

    PMID: 34013969DERIVED

  • 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.

    PMID: 33044747DERIVED

  • 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.

    PMID: 32648959DERIVED

  • 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.

    PMID: 32468508DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Cesare Perotti, MD

    Fondazione IRCCS Policlinico San Matteo di Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Longitudinal assessment of COVID-19 patients treated with hyperimmune plasma
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Immunohematology & Transfusion Service

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

March 17, 2020

Primary Completion

April 28, 2020

Study Completion

May 7, 2020

Last Updated

May 28, 2020

Record last verified: 2020-05

Locations

IT(2)