Covid19NCT04716556
TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients
A study testing Convalescent plasma in people with Covid19 and Coronavirus Infection, run by Istituto Superiore di Sanità at 48 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Coronavirus Infection, Pneumonia, Viral
- What is being tested?
- Convalescent plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 48 sitesItaly
- Study dates
- 16 Jul 2020to 31 May 2021
- 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 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
Who cannot join
- 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.
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
Italy48 sites
SOD Clinica Malattie Infettive Tropicali, Parassitologia, Epatiti Croniche - AOU Ospedali Riuniti di Ancona
Ancona
Ospedale di Arezzo
Arezzo
Clinica Malattie Infettive, Università degli Studi di Bari
Bari
Ospedale Papa Giovanni XXIII-Dip. emergenza, Urgenza e area critica
Bergamo
UOC Malattie Infettive - AOU Bologna
Bologna
UO PID Tossicologia Applicata - Dip. Scienze Biomediche e Biotecnologiche - Università di Catania - AOU Policlinico Vittorio Emanuele
Catania
Ospedale Città di Castello
Città di Castello
Ospedale di Empoli
Empoli
UOC Malattie Infettive - ASUR Marche Area Vasta 4
Fermo
UOC Malattie Infettive - AOU Ferrara
Ferrara
Ospedale Santa Maria Annunziata
Florence
SOD Malattie Infettive e Tropicali - AOU Careggi
Florence
Dip.Medicina Clinica e Sperimentale - Policlinico "Riuniti" di Foggia
Foggia
Nuovo Ospedale S. Giovanni Battista Usl Umbria2
Foligno
U.O.C. Malattie Infettive ASL Frosinone
Frosinone
U.O. Malattie Infettive IRCCS-Ospedale Policlinico San Martino
Genova
Ospedale di Grosseto
Grosseto
ASL 5 Spezzina - SC Malattie Infettive
La Spezia
ASST Lecco - Malattie Infettive
Lecco
Ospedale di Livorno
Livorno
Ospedale di Lucca
Lucca
S.C. Pneumologia e Utir ASST Mantova - Ospedale Carlo Poma
Mantua
Ospedale Dell'Angelo - UOC Malattie Infettive
Mestre
ASST Santi Paolo e Carlo
Milan
Ospedale Luigi Sacco
Milan
SC Malattie Infettive ASST Grande Ospedale Metropolitano Niguarda
Milan
Ospedale San Gerardo
Monza
Malattie Infettive - AOU Federico II di Napoli
Naples
UOC Malattie Infettive ad indirizzo Respiratorio - PO Cotugno - AORN "Dei Colli"
Naples
UOC Malattie Infettive e Tropicali - AOU Policlinico
Palermo
Dip. Medicina Diagnost. e Servizi Fondazione IRCCS Policlinico San Matteo
Pavia
Azienda Ospedaliero-Universitaria di Perugia
Perugia
UOC Malattie Infettive - Azienda Ospedali Riuniti Marche Nord
Pesaro
AOU Pisana
Pisa
Ospedale Pistoia
Pistoia
Ospedale Prato
Prato
Malattie Infettive Ravenna
Ravenna
UOC Malattie Infettive - AUSL Reggio Emilia
Reggio Emilia
Malattie Infettive - Rimini Forlì Cesena
Rimini
Campus Bio Medico - UO Anestesia e Rianimazione
Roma
ASL 1 Imperiese - SC Malattie Infettive
Sanremo
ASL 2 Savonese - SC Malattie Infettive
Savona
Ospedale di Siena
Siena
Ospedale di Sondrio - dipartimento di Medicina
Sondrio
AOU di Terni
Terni
Ospedale Ca Foncello - UOC Malattie Infettive
Treviso
A.O. Integrata Università di Verona
Verona
Ospedale Viareggio
Viareggio
About this study
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
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
Read the 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.
- Conditions
- Covid19, Coronavirus Infection, Pneumonia, Viral
- Being tested
- Convalescent plasma
- Keywords
- plasma
- Medical subject headings
- COVID-19, Coronavirus Infections, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent plasmaBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy+Convalescent Plasma | Experimental | Patients will receive standard therapy + 200-300 ml of convalescent plasma for a maximum of 3 times in 5 days, according to clinical conditions. Receives: Biological: Convalescent plasma |
| Standard Therapy | No intervention | Patients will receive standard therapy for the treatment of SARS-CoV2 infection, according to AIFA indications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 30 days
Secondary outcomes (5)
Mortality rates
Mortality rates at 30 days
Measured: 30 days
Time to invasive mechanical ventilation or death
Days from randomization to invasive mechanical ventilation or death
Measured: 30 days
Time to virologic recover
Days from randomization to virologic recover (defined as 2 consecutive negative nasopharynx tests)
Measured: 30 days
Hospitalization time
Measured: 30 days
Adverse events
occurrence of Adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start16 Jul 2020
- Primary completion14 Jan 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Superiore di Sanità
- Sponsor type
- University, hospital or other
- Collaborators
- Gruppo Italiano Malattie EMatologiche dell'Adulto, Agenzia Italiana del Farmaco
- Responsible party
- Principal investigator, Elena Toschi, Istituto Superiore di Sanità
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716556
- Sponsor's protocol ID
- TSUNAMI
- Status last verified
- Aug 2021
- First submitted
- 14 Jan 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34842924
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04716556
- Acronym / sponsor ID
- TSUNAMI
- Conditions
- Covid19, Coronavirus Infection, Pneumonia, Viral
- Keywords
- plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Istituto Superiore di SanitàUniversity, hospital or other
- Collaborators
- Gruppo Italiano Malattie EMatologiche dell'Adulto, Agenzia Italiana del Farmaco
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy+Convalescent Plasma | Experimental | Biological: Convalescent plasmaPatients will receive standard therapy + 200-300 ml of convalescent plasma for a maximum of 3 times in 5 days, according to clinical conditions. |
| Standard Therapy | No intervention | –Patients will receive standard therapy for the treatment of SARS-CoV2 infection, according to AIFA indications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Convalescent plasmaConvalescent 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 | Biological | Standard Therapy+Convalescent Plasma |
Primary outcome
Number of patients who meet invasive mechanical ventilation or death
Time frame: at 30 days
Number of patients who meet invasive mechanical ventilation defined as PaO2/FiO2 <150 or death
5 secondary outcomes
Mortality rates
Time frame: 30 days
Time to invasive mechanical ventilation or death
Time frame: 30 days
Time to virologic recover
Time frame: 30 days
Hospitalization time
Time frame: 30 days
Adverse events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Derived from this study: PubMed 34842924Menichetti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Convalescent plasma in people with Covid19 and Coronavirus Infection, run by Istituto Superiore di Sanità at 48 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 6 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 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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?
Number of patients who meet invasive mechanical ventilation or death (time frame: at 30 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 NCT04716556, which also lists 1 linked publication.
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 26 Aug 2021.