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TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients

Primary Purpose

Covid19, Coronavirus Infection, Pneumonia, Viral

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Convalescent plasma
Sponsored by
Istituto Superiore di Sanità
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years old

  • adult patients with positive RT-PCR test for SARS-CoV2 (nasal swabs or lower respiratory tract sample), diagnosed with pneumonia (<= 10 days) according to the following definitions:

    • Suggestive radiological imaging (CT, RX, ultrasound);
    • Respiratory failure not fully explained by heart failure or fluid overload;
    • PaO2/FiO2 200-350 mmHg;
    • Signed informed consent

Exclusion Criteria:

  • need of non invasive or invasive mechanical ventilation at the time of randomization;
  • PaO2/FiO2 <200;
  • patients with hypersensitivity or allergic reaction to blood products or immunoglobulins;
  • patients who expressly refuse to adhere the clinical study;
  • use of IL-6 Receptor inhibitors, IL-1 inhibitors, JAK inhibitors, TNF inhibitors;
  • patients participating to other clinical trial.

Sites / Locations

  • SOD Clinica Malattie Infettive Tropicali, Parassitologia, Epatiti Croniche - AOU Ospedali Riuniti di Ancona
  • Ospedale di Arezzo
  • Clinica Malattie Infettive, Università degli Studi di Bari
  • Ospedale Papa Giovanni XXIII-Dip. emergenza, Urgenza e area critica
  • UOC Malattie Infettive - AOU Bologna
  • UO PID Tossicologia Applicata - Dip. Scienze Biomediche e Biotecnologiche - Università di Catania - AOU Policlinico Vittorio Emanuele
  • Ospedale Città di Castello
  • Ospedale di Empoli
  • UOC Malattie Infettive - ASUR Marche Area Vasta 4
  • UOC Malattie Infettive - AOU Ferrara
  • Ospedale Santa Maria Annunziata
  • SOD Malattie Infettive e Tropicali - AOU Careggi
  • Dip.Medicina Clinica e Sperimentale - Policlinico "Riuniti" di Foggia
  • Nuovo Ospedale S. Giovanni Battista Usl Umbria2
  • U.O.C. Malattie Infettive ASL Frosinone
  • U.O. Malattie Infettive IRCCS-Ospedale Policlinico San Martino
  • Ospedale di Grosseto
  • ASL 5 Spezzina - SC Malattie Infettive
  • ASST Lecco - Malattie Infettive
  • Ospedale di Livorno
  • Ospedale di Lucca
  • S.C. Pneumologia e Utir ASST Mantova - Ospedale Carlo Poma
  • Ospedale Dell'Angelo - UOC Malattie Infettive
  • ASST Santi Paolo e Carlo
  • Ospedale Luigi Sacco
  • SC Malattie Infettive ASST Grande Ospedale Metropolitano Niguarda
  • Ospedale San Gerardo
  • Malattie Infettive - AOU Federico II di Napoli
  • UOC Malattie Infettive ad indirizzo Respiratorio - PO Cotugno - AORN "Dei Colli"
  • UOC Malattie Infettive e Tropicali - AOU Policlinico
  • Dip. Medicina Diagnost. e Servizi Fondazione IRCCS Policlinico San Matteo
  • Azienda Ospedaliero-Universitaria di Perugia
  • UOC Malattie Infettive - Azienda Ospedali Riuniti Marche Nord
  • AOU Pisana
  • Ospedale Pistoia
  • Ospedale Prato
  • Malattie Infettive Ravenna
  • UOC Malattie Infettive - AUSL Reggio Emilia
  • Malattie Infettive - Rimini Forlì Cesena
  • Campus Bio Medico - UO Anestesia e Rianimazione
  • ASL 1 Imperiese - SC Malattie Infettive
  • ASL 2 Savonese - SC Malattie Infettive
  • Ospedale di Siena
  • Ospedale di Sondrio - dipartimento di Medicina
  • AOU di Terni
  • Ospedale Ca Foncello - UOC Malattie Infettive
  • A.O. Integrata Università di Verona
  • Ospedale Viareggio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Standard Therapy+Convalescent Plasma

Standard Therapy

Arm Description

Patients will receive standard therapy + 200-300 ml of convalescent plasma for a maximum of 3 times in 5 days, according to clinical conditions.

Patients will receive standard therapy for the treatment of SARS-CoV2 infection, according to AIFA indications

Outcomes

Primary Outcome Measures

Number of patients who meet invasive mechanical ventilation or death
Number of patients who meet invasive mechanical ventilation defined as PaO2/FiO2 <150 or death

Secondary Outcome Measures

Mortality rates
Mortality rates at 30 days
Time to invasive mechanical ventilation or death
Days from randomization to invasive mechanical ventilation or death
Time to virologic recover
Days from randomization to virologic recover (defined as 2 consecutive negative nasopharynx tests)
Hospitalization time
Adverse events
occurrence of Adverse events

Full Information

First Posted
January 14, 2021
Last Updated
August 25, 2021
Sponsor
Istituto Superiore di Sanità
Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto, Agenzia Italiana del Farmaco
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1. Study Identification

Unique Protocol Identification Number
NCT04716556
Brief Title
TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients
Official Title
TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa Due to SARS-CoV2 (TSUNAMI Study): a Multicenter Open Label Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 16, 2020 (Actual)
Primary Completion Date
January 14, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Superiore di Sanità
Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto, Agenzia Italiana del Farmaco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a multicenter open-label randomized study for the early treatment of pneumonia due to SARS-COV2 with transfusion of convalescent plasma. Patients with pneumonia due to SARS-CoV-2 will be randomized to receive or not convalescent plasma collected by recovered patients with previous diagnosis of COVID19
Detailed Description
This is a multicenter open-label randomized study for the early treatment of pneumonia due to SARS-COV2 with transfusion of convalescent plasma. Patients with SARS-CoV2 pneumonia not requiring mechanical ventilation (both non invasive and invasive) will be randomized to receive or not convalescent plasma. Patients in the plasma group will receive 200-300 ml of plasma collected by recovered patients with previous diagnosis of COVID19, plus standard therapy; Patients in the control group will receive the standard therapy. A rescue therapy will be allowed in case of clinical worsening. Patients will be followed until day n30 from randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Coronavirus Infection, Pneumonia, Viral
Keywords
plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
474 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Therapy+Convalescent Plasma
Arm Type
Experimental
Arm Description
Patients will receive standard therapy + 200-300 ml of convalescent plasma for a maximum of 3 times in 5 days, according to clinical conditions.
Arm Title
Standard Therapy
Arm Type
No Intervention
Arm Description
Patients will receive standard therapy for the treatment of SARS-CoV2 infection, according to AIFA indications
Intervention Type
Biological
Intervention Name(s)
Convalescent plasma
Intervention Description
Convalescent plasma will be collected by healthy donors, recovered by COVID19 and, after standard preparation and dosage of neutralizing antibodies, it will be administered to patients with SARS-CoV2 pneumonia
Primary Outcome Measure Information:
Title
Number of patients who meet invasive mechanical ventilation or death
Description
Number of patients who meet invasive mechanical ventilation defined as PaO2/FiO2 <150 or death
Time Frame
at 30 days
Secondary Outcome Measure Information:
Title
Mortality rates
Description
Mortality rates at 30 days
Time Frame
30 days
Title
Time to invasive mechanical ventilation or death
Description
Days from randomization to invasive mechanical ventilation or death
Time Frame
30 days
Title
Time to virologic recover
Description
Days from randomization to virologic recover (defined as 2 consecutive negative nasopharynx tests)
Time Frame
30 days
Title
Hospitalization time
Time Frame
30 days
Title
Adverse events
Description
occurrence of Adverse events
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Evaluation of CD4/CD8 ratio
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old adult patients with positive RT-PCR test for SARS-CoV2 (nasal swabs or lower respiratory tract sample), diagnosed with pneumonia (<= 10 days) according to the following definitions: Suggestive radiological imaging (CT, RX, ultrasound); Respiratory failure not fully explained by heart failure or fluid overload; PaO2/FiO2 200-350 mmHg; Signed informed consent Exclusion Criteria: need of non invasive or invasive mechanical ventilation at the time of randomization; PaO2/FiO2 <200; patients with hypersensitivity or allergic reaction to blood products or immunoglobulins; patients who expressly refuse to adhere the clinical study; use of IL-6 Receptor inhibitors, IL-1 inhibitors, JAK inhibitors, TNF inhibitors; patients participating to other clinical trial.
Facility Information:
Facility Name
SOD Clinica Malattie Infettive Tropicali, Parassitologia, Epatiti Croniche - AOU Ospedali Riuniti di Ancona
City
Ancona
Country
Italy
Facility Name
Ospedale di Arezzo
City
Arezzo
Country
Italy
Facility Name
Clinica Malattie Infettive, Università degli Studi di Bari
City
Bari
Country
Italy
Facility Name
Ospedale Papa Giovanni XXIII-Dip. emergenza, Urgenza e area critica
City
Bergamo
Country
Italy
Facility Name
UOC Malattie Infettive - AOU Bologna
City
Bologna
Country
Italy
Facility Name
UO PID Tossicologia Applicata - Dip. Scienze Biomediche e Biotecnologiche - Università di Catania - AOU Policlinico Vittorio Emanuele
City
Catania
Country
Italy
Facility Name
Ospedale Città di Castello
City
Città Di Castello
Country
Italy
Facility Name
Ospedale di Empoli
City
Empoli
Country
Italy
Facility Name
UOC Malattie Infettive - ASUR Marche Area Vasta 4
City
Fermo
Country
Italy
Facility Name
UOC Malattie Infettive - AOU Ferrara
City
Ferrara
Country
Italy
Facility Name
Ospedale Santa Maria Annunziata
City
Firenze
Country
Italy
Facility Name
SOD Malattie Infettive e Tropicali - AOU Careggi
City
Firenze
Country
Italy
Facility Name
Dip.Medicina Clinica e Sperimentale - Policlinico "Riuniti" di Foggia
City
Foggia
Country
Italy
Facility Name
Nuovo Ospedale S. Giovanni Battista Usl Umbria2
City
Foligno
Country
Italy
Facility Name
U.O.C. Malattie Infettive ASL Frosinone
City
Frosinone
Country
Italy
Facility Name
U.O. Malattie Infettive IRCCS-Ospedale Policlinico San Martino
City
Genova
Country
Italy
Facility Name
Ospedale di Grosseto
City
Grosseto
Country
Italy
Facility Name
ASL 5 Spezzina - SC Malattie Infettive
City
La Spezia
Country
Italy
Facility Name
ASST Lecco - Malattie Infettive
City
Lecco
Country
Italy
Facility Name
Ospedale di Livorno
City
Livorno
Country
Italy
Facility Name
Ospedale di Lucca
City
Lucca
Country
Italy
Facility Name
S.C. Pneumologia e Utir ASST Mantova - Ospedale Carlo Poma
City
Mantova
Country
Italy
Facility Name
Ospedale Dell'Angelo - UOC Malattie Infettive
City
Mestre
Country
Italy
Facility Name
ASST Santi Paolo e Carlo
City
Milano
Country
Italy
Facility Name
Ospedale Luigi Sacco
City
Milano
Country
Italy
Facility Name
SC Malattie Infettive ASST Grande Ospedale Metropolitano Niguarda
City
Milano
Country
Italy
Facility Name
Ospedale San Gerardo
City
Monza
Country
Italy
Facility Name
Malattie Infettive - AOU Federico II di Napoli
City
Napoli
Country
Italy
Facility Name
UOC Malattie Infettive ad indirizzo Respiratorio - PO Cotugno - AORN "Dei Colli"
City
Napoli
Country
Italy
Facility Name
UOC Malattie Infettive e Tropicali - AOU Policlinico
City
Palermo
Country
Italy
Facility Name
Dip. Medicina Diagnost. e Servizi Fondazione IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Perugia
City
Perugia
Country
Italy
Facility Name
UOC Malattie Infettive - Azienda Ospedali Riuniti Marche Nord
City
Pesaro
Country
Italy
Facility Name
AOU Pisana
City
Pisa
Country
Italy
Facility Name
Ospedale Pistoia
City
Pistoia
Country
Italy
Facility Name
Ospedale Prato
City
Prato
Country
Italy
Facility Name
Malattie Infettive Ravenna
City
Ravenna
Country
Italy
Facility Name
UOC Malattie Infettive - AUSL Reggio Emilia
City
Reggio Emilia
Country
Italy
Facility Name
Malattie Infettive - Rimini Forlì Cesena
City
Rimini
Country
Italy
Facility Name
Campus Bio Medico - UO Anestesia e Rianimazione
City
Roma
Country
Italy
Facility Name
ASL 1 Imperiese - SC Malattie Infettive
City
Sanremo
Country
Italy
Facility Name
ASL 2 Savonese - SC Malattie Infettive
City
Savona
Country
Italy
Facility Name
Ospedale di Siena
City
Siena
Country
Italy
Facility Name
Ospedale di Sondrio - dipartimento di Medicina
City
Sondrio
Country
Italy
Facility Name
AOU di Terni
City
Terni
Country
Italy
Facility Name
Ospedale Ca Foncello - UOC Malattie Infettive
City
Treviso
Country
Italy
Facility Name
A.O. Integrata Università di Verona
City
Verona
Country
Italy
Facility Name
Ospedale Viareggio
City
Viareggio
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
34842924
Citation
Menichetti F, Popoli P, Puopolo M, Spila Alegiani S, Tiseo G, Bartoloni A, De Socio GV, Luchi S, Blanc P, Puoti M, Toschi E, Massari M, Palmisano L, Marano G, Chiamenti M, Martinelli L, Franchi S, Pallotto C, Suardi LR, Luciani Pasqua B, Merli M, Fabiani P, Bertolucci L, Borchi B, Modica S, Moneta S, Marchetti G, d'Arminio Monforte A, Stoppini L, Ferracchiato N, Piconi S, Fabbri C, Beccastrini E, Saccardi R, Giacometti A, Esperti S, Pierotti P, Bernini L, Bianco C, Benedetti S, Lanzi A, Bonfanti P, Massari M, Sani S, Saracino A, Castagna A, Trabace L, Lanza M, Focosi D, Mazzoni A, Pistello M, Falcone M; TSUNAMI Study group. Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients With COVID-19 Pneumonia: A Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2136246. doi: 10.1001/jamanetworkopen.2021.36246. Erratum In: JAMA Netw Open. 2021 Dec 1;4(12):e2144236. JAMA Netw Open. 2022 Jan 4;5(1):e2146944.
Results Reference
derived

Learn more about this trial

TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients

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