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

Sponsor

Istituto Superiore di Sanità (Other)

Overall Status

Completed

CT.gov ID

NCT04716556

Collaborator

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other), Agenzia Italiana del Farmaco (Other)

474

Enrollment

Locations

Arms

10.5

Actual Duration (Months)

9.9

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 Coronavirus Infection Pneumonia, Viral	Biological: Convalescent plasma	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

474 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 16, 2020

Actual Primary Completion Date :

Jan 14, 2021

Actual Study Completion Date :

May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard Therapy+Convalescent Plasma Patients will receive standard therapy + 200-300 ml of convalescent plasma for a maximum of 3 times in 5 days, according to clinical conditions.	Biological: Convalescent plasma 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
No Intervention: Standard Therapy Patients will receive standard therapy for the treatment of SARS-CoV2 infection, according to AIFA indications

Arm

Intervention/Treatment

Experimental: Standard Therapy+Convalescent Plasma

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

Biological: Convalescent plasma

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

No Intervention: Standard Therapy

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

Outcome Measures

Primary Outcome Measures

Number of patients who meet invasive mechanical ventilation or death [at 30 days]
Number of patients who meet invasive mechanical ventilation defined as PaO2/FiO2 <150 or death

Secondary Outcome Measures

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

Other Outcome Measures

Evaluation of CD4/CD8 ratio [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country
1	SOD Clinica Malattie Infettive Tropicali, Parassitologia, Epatiti Croniche - AOU Ospedali Riuniti di Ancona	Ancona	Italy
2	Ospedale di Arezzo	Arezzo	Italy
3	Clinica Malattie Infettive, Università degli Studi di Bari	Bari	Italy
4	Ospedale Papa Giovanni XXIII-Dip. emergenza, Urgenza e area critica	Bergamo	Italy
5	UOC Malattie Infettive - AOU Bologna	Bologna	Italy
6	UO PID Tossicologia Applicata - Dip. Scienze Biomediche e Biotecnologiche - Università di Catania - AOU Policlinico Vittorio Emanuele	Catania	Italy
7	Ospedale Città di Castello	Città Di Castello	Italy
8	Ospedale di Empoli	Empoli	Italy
9	UOC Malattie Infettive - ASUR Marche Area Vasta 4	Fermo	Italy
10	UOC Malattie Infettive - AOU Ferrara	Ferrara	Italy
11	Ospedale Santa Maria Annunziata	Firenze	Italy
12	SOD Malattie Infettive e Tropicali - AOU Careggi	Firenze	Italy
13	Dip.Medicina Clinica e Sperimentale - Policlinico "Riuniti" di Foggia	Foggia	Italy
14	Nuovo Ospedale S. Giovanni Battista Usl Umbria2	Foligno	Italy
15	U.O.C. Malattie Infettive ASL Frosinone	Frosinone	Italy
16	U.O. Malattie Infettive IRCCS-Ospedale Policlinico San Martino	Genova	Italy
17	Ospedale di Grosseto	Grosseto	Italy
18	ASL 5 Spezzina - SC Malattie Infettive	La Spezia	Italy
19	ASST Lecco - Malattie Infettive	Lecco	Italy
20	Ospedale di Livorno	Livorno	Italy
21	Ospedale di Lucca	Lucca	Italy
22	S.C. Pneumologia e Utir ASST Mantova - Ospedale Carlo Poma	Mantova	Italy
23	Ospedale Dell'Angelo - UOC Malattie Infettive	Mestre	Italy
24	ASST Santi Paolo e Carlo	Milano	Italy
25	Ospedale Luigi Sacco	Milano	Italy
26	SC Malattie Infettive ASST Grande Ospedale Metropolitano Niguarda	Milano	Italy
27	Ospedale San Gerardo	Monza	Italy
28	Malattie Infettive - AOU Federico II di Napoli	Napoli	Italy
29	UOC Malattie Infettive ad indirizzo Respiratorio - PO Cotugno - AORN "Dei Colli"	Napoli	Italy
30	UOC Malattie Infettive e Tropicali - AOU Policlinico	Palermo	Italy
31	Dip. Medicina Diagnost. e Servizi Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
32	Azienda Ospedaliero-Universitaria di Perugia	Perugia	Italy
33	UOC Malattie Infettive - Azienda Ospedali Riuniti Marche Nord	Pesaro	Italy
34	AOU Pisana	Pisa	Italy
35	Ospedale Pistoia	Pistoia	Italy
36	Ospedale Prato	Prato	Italy
37	Malattie Infettive Ravenna	Ravenna	Italy
38	UOC Malattie Infettive - AUSL Reggio Emilia	Reggio Emilia	Italy
39	Malattie Infettive - Rimini Forlì Cesena	Rimini	Italy
40	Campus Bio Medico - UO Anestesia e Rianimazione	Roma	Italy
41	ASL 1 Imperiese - SC Malattie Infettive	Sanremo	Italy
42	ASL 2 Savonese - SC Malattie Infettive	Savona	Italy
43	Ospedale di Siena	Siena	Italy
44	Ospedale di Sondrio - dipartimento di Medicina	Sondrio	Italy
45	AOU di Terni	Terni	Italy
46	Ospedale Ca Foncello - UOC Malattie Infettive	Treviso	Italy
47	A.O. Integrata Università di Verona	Verona	Italy
48	Ospedale Viareggio	Viareggio	Italy

Sponsors and Collaborators

Istituto Superiore di Sanità
Gruppo Italiano Malattie EMatologiche dell'Adulto
Agenzia Italiana del Farmaco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elena Toschi, Research Coordinator, Istituto Superiore di Sanità

ClinicalTrials.gov Identifier:

NCT04716556

Other Study ID Numbers:

TSUNAMI

First Posted:

Jan 20, 2021

Last Update Posted:

Aug 26, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elena Toschi, Research Coordinator, Istituto Superiore di Sanità

plasma

Additional relevant MeSH terms:

COVID-19

Pneumonia

Coronavirus Infections

Pneumonia, Viral

Study Results

No Results Posted as of Aug 26, 2021