NCT04385043

Brief Summary

Passive immunotherapy through plasma infusion of convalescent subjects - convalescent plasma - or "hyperimmune" plasma was one of the most widespread and effective anti-infective treatments in the pre-antibiotic era and one of the founding pillars of immunology, and has also been used during the SARS (2002-2003) and Ebola (2014-2016) viral epidemy for which there were no alternative immunoprophylactic or therapeutic interventions. To date, there are not proven etiological therapies for SARS-CoV-2 infection, the agent responsible for the disease called Covid-19. Among those subjected to clinical studies during the current epidemic in China, hyperimmune plasma appears to be one of the most rational and promising. The objective of this study will be to evaluate the efficacy and safety of the hyperimmune plasma administered add-on to the anti-Covid-19 treatment (standard therapy) according to clinical practice in patients with severe Covid-19 infection, compared to patients with severe Covid-19 infection treated only with standard therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started May 2020

Typical duration for phase_2 covid19

Geographic Reach
1 country

6 active sites

Status
unknown

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

May 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 4, 2020

Last Update Submit

May 11, 2020

Conditions

COVID-19

Keywords

severe Covid-19severe coronavirus-2plasma hyperimmuneconvalescent plasma

Outcome Measures

Primary Outcomes (1)

  • decrease in mortality

    Statistically significant reduction (P \<0.05) of mortality in the group of patients treated with hyperimmune plasma vs patients treated with standard therapy.

    30 days

Secondary Outcomes (6)

  • lymphocytes

    7 and 14 days

  • PCR levels vs control

    7 and 14 days

  • PCR levels vs before treatment

    7 and 14 days

  • AB levels and clinical improvement

    30 days

  • Inflammatory cytokines vs controls

    7 and 14 days

  • +1 more secondary outcomes

Study Arms (2)

plasma-hyperimmune

EXPERIMENTAL

enrolled patients (n=200) with severe Covid-19 infection will receive a treatment with plasma hyperimmune add on to the standard therapy

Other: plasma hyperimmuneDrug: standard therapy

standard therapy

ACTIVE COMPARATOR

enrolled patients (n=200) with severe Covid-19 infection will receive a treatment with the standard therapy

Drug: standard therapy

Interventions

plasma hyperimmuneOTHER

patients will receive this as add on therapy

plasma-hyperimmune
standard therapyDRUG

patients will receive only standard therapy for Covid-19 infection

plasma-hyperimmunestandard therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Azienda Ospedaliera Policlinico Mater Domini

Catanzaro, 88100, Italy

RECRUITING

Azienda Ospedaliera Pugliese Ciaccio Catanzaro

Catanzaro, 88100, Italy

RECRUITING

Azienda Ospedaliera Annunziata

Cosenza, 87100, Italy

RECRUITING

Azienda Sanitaria Provinciale

Crotone, 88900, Italy

RECRUITING

Azienda Ospedaliera Bianchi Melacrino Morelli

Reggio Calabria, 89133, Italy

RECRUITING

Azienda Sanitaria Provinciale

Vibo Valentia, 89900, Italy

RECRUITING

Related Publications (7)

  • 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.

    PMID: 26674811BACKGROUND

  • 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

  • Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.

    PMID: 32167489BACKGROUND

  • 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.

    PMID: 25030060RESULT

  • Linee Guida Cinesi sulla Gestione di COVID-19 Versione 7° Pubblicate in data 3/3/2020 dalla Commissione della Salute Nazionale della R.P.C..

    RESULT

  • 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: 26618098RESULT

  • Dean CL, Hooper JW, Dye JM, Zak SE, Koepsell SA, Corash L, Benjamin RJ, Kwilas S, Bonds S, Winkler AM, Kraft CS. Characterization of Ebola convalescent plasma donor immune response and psoralen treated plasma in the United States. Transfusion. 2020 May;60(5):1024-1031. doi: 10.1111/trf.15739. Epub 2020 Mar 4.

    PMID: 32129478RESULT

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 SerotherapyStandard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Gabriella Talarico, MD

CONTACT

0961883111trasfusionale@aocz.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 12, 2020

Study Start

May 1, 2020

Primary Completion

October 15, 2020

Study Completion

May 15, 2021

Last Updated

May 12, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(6)