COVIDPhase 2TSUNAMINCT04393727
Transfusion of Convalescent Plasma for the Early Treatment of Patients With COVID-19
A Phase 2 study testing CONVALESCENT PLASMA in people with COVID and SARS-CoV 2, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma was recommended as an empirical treatment during outbreaks of Ebola virus in 2014, and a protocol for treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, SARS-CoV 2
- What is being tested?
- CONVALESCENT PLASMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2020to 30 Sep 2020
- Phase
- Phase 2
- 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
- Any gender
- Age > 18 years on day of signing informed consent
- Informed written consent for participation in the study
- Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
- Hospitalized due to clinical instrumental diagnosis of pneumonia
- PaO2/FiO2 ratio 200-350
Who cannot join
- mechanical ventilation (both invasive and non-invasive)
- PaO2/FiO2<200
- known hypersensitivity to immunoglobulin or blood components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transfusion of Convalescent Plasma for the Early Treatment of pneumonIa Due to SARSCoV2: a Multicenter Open Label Randomized Control Trial
No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma was recommended as an empirical treatment during outbreaks of Ebola virus in 2014, and a protocol for treatment of Middle East respiratory syndrome coronavirus with convalescent plasma was established in 2015. Accordingly, we hypothesized that use of convalescent plasma transfusion could be beneficial in patients infected with SARS-CoV-2.
This is a multicenter prospective randomized clinical trial to evaluate safety and efficacy of early use of convalescent plasma in patients with SARS-CoV2 pneumonia.
Read more
Primary endpoint will be the efficacy, evaluated as the need of invasive mechanical ventilation defined by PaO2/FiO2 ratio <150.
Secondary endpoints will be: mortality rates, time to invasive mechanical ventilation, time to virological cure, length of hospital stay, toxicity.
Patients with SARS-CoV2 pneumonia not requiring mechanical ventilation (both non invasive and invasive) will be randomized 1:1 to receive or not convalescent plasma. Patients in the plasma group will receive 200 ml of convalescent plasma, continuing already administered standard therapy, while patients in the control group will continue to receive the standard therapy. A rescue therapy will be allowed in case of clinical worsening.
Patients will be followed-up until 30 days from randomization.
Read the detailed description
This is a multicenter prospective randomized open-label clinical trials. Patients with pneumonia due to SARS-CoV-2 will be included and randomized to receive or not convalescent plasma.
Convalescent plasma will be collected by cured patients with previous diagnosis of COVID-19. More specifically, inclusion and exclusion criteria for donors will be the following.
Inclusion criteria for donors:
- age > 18 and <60 years
- confirmed diagnosis of COVID-19: PCR on nasopharynx swab or positive IgG
- presence of 2 negative nasopharynx swabs for patients with previous positive swab and presence of 1 negative nasopharynx swab for patients with positive IgG
Exclusion criteria for donors:
- age < 18 ys or >60 ys
- other conditions that controindicate blood donation
Collected plasma will undergo all procedures for blood preparation. Plasma will be tested with enzyme-linked immunosorbent assay (ELISA) and neutralizing antibody titers.
Patients eligible for the study will be selected among hospitalized patients with SARS-CoV2 pneumonia. More specifically, the following criteria will used for inclusion in the study.
Inclusion criteria for recipients:
- age >18 ys
- confirmed diagnosis of SARS-CoV2 pneumonia
- PaO2/FiO2 200-350
Exclusion criteria for recipients:
- PaO2/FiO2 <200
- need of non invasive or invasive mechanical ventilation
Patients will be randomized 1:1 to receive or not convalescent plasma. All patients will be followed-up for 30 days after randomization.
Primary endpoint will be the need of mechanical ventilation, defined as PaO2/FiO2 <150.
- Conditions
- COVID, SARS-CoV 2
- Being tested
- CONVALESCENT PLASMA
- Keywords
- covid-19, SARS-CoV2, pneumonia, convalescent plasma
- Medical subject headings
- COVID-19, Pneumonia
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, cured by COVID-19 and, after standard preparation and dosage of neutralizing antibodies, will be administered to patients with SARS-CoV2 pneumonia
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients in the intervention group will receive 200 cc of convalescent plasma Receives: Biological: CONVALESCENT PLASMA |
| Control | No intervention | Patients will continue to receive standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need of invasive mechanical ventilation
Need of invasive mechanical ventilation defined as PaO2/FiO2 <150
Measured: 30 days
Secondary outcomes (5)
Mortality rates
Thirty-day mortality rates
Measured: 30 days
Time to invasive mechanical ventilation
Days from randomization to invasive mechanical ventilation
Measured: 30 days
Time to virologic cure
Days from randomization to virologic cure defined as 2 consecutive negative nasopharynx swabs
Measured: 30 days
Length of hospital stay
Days from randomization to discharge or death
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 posted19 May 2020
- Study start1 May 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Why it stopped: Study was stopped because the Promoter was changed and a new study on convalescent plasma promoted by AIFA was started in Italy.
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 COVIDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Menichetti, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Francesco Menichetti, Principal investigator, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393727
- Sponsor's protocol ID
- TSUNAMI
- Acronym
- TSUNAMI
- Status last verified
- Nov 2020
- First submitted
- 16 May 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
PubMed 32219428
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. 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 SARSCoV2: a Multicenter Open Label Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04393727
- Acronym / sponsor ID
- TSUNAMI / TSUNAMI
- Conditions
- COVID, SARS-CoV 2
- Keywords
- covid-19, SARS-CoV2, pneumonia, convalescent plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped because the Promoter was changed and a new study on convalescent plasma promoted by AIFA was started in Italy.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 19 May 2020 (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.
No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma was recommended as an empirical treatment during outbreaks of Ebola virus in 2014, and a protocol for treatment of Middle East respiratory syndrome coronavirus with convalescent plasma was established in 2015. Accordingly, we hypothesized that use of convalescent plasma transfusion could be beneficial in patients infected with SARS-CoV-2.
This is a multicenter prospective randomized clinical trial to evaluate safety and efficacy of early use of convalescent plasma in patients with SARS-CoV2 pneumonia.
Primary endpoint will be the efficacy, evaluated as the need of invasive mechanical ventilation defined by PaO2/FiO2 ratio <150.
Secondary endpoints will be: mortality rates, time to invasive mechanical ventilation, time to virological cure, length of hospital stay, toxicity.
Patients with SARS-CoV2 pneumonia not requiring mechanical ventilation (both non invasive and invasive) will be randomized 1:1 to receive or not convalescent plasma. Patients in the plasma group will receive 200 ml of convalescent plasma, continuing already administered standard therapy, while patients in the control group will continue to receive the standard therapy. A rescue therapy will be allowed in case of clinical worsening.
Patients will be followed-up until 30 days from randomization.
Detailed description
This is a multicenter prospective randomized open-label clinical trials. Patients with pneumonia due to SARS-CoV-2 will be included and randomized to receive or not convalescent plasma.
Convalescent plasma will be collected by cured patients with previous diagnosis of COVID-19. More specifically, inclusion and exclusion criteria for donors will be the following.
Inclusion criteria for donors:
- age > 18 and <60 years
- confirmed diagnosis of COVID-19: PCR on nasopharynx swab or positive IgG
- presence of 2 negative nasopharynx swabs for patients with previous positive swab and presence of 1 negative nasopharynx swab for patients with positive IgG
Exclusion criteria for donors:
- age < 18 ys or >60 ys
- other conditions that controindicate blood donation
Collected plasma will undergo all procedures for blood preparation. Plasma will be tested with enzyme-linked immunosorbent assay (ELISA) and neutralizing antibody titers.
Patients eligible for the study will be selected among hospitalized patients with SARS-CoV2 pneumonia. More specifically, the following criteria will used for inclusion in the study.
Inclusion criteria for recipients:
- age >18 ys
- confirmed diagnosis of SARS-CoV2 pneumonia
- PaO2/FiO2 200-350
Exclusion criteria for recipients:
- PaO2/FiO2 <200
- need of non invasive or invasive mechanical ventilation
Patients will be randomized 1:1 to receive or not convalescent plasma. All patients will be followed-up for 30 days after randomization.
Primary endpoint will be the need of mechanical ventilation, defined as PaO2/FiO2 <150.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: CONVALESCENT PLASMAPatients in the intervention group will receive 200 cc of convalescent plasma |
| Control | No intervention | –Patients will continue to receive standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Any gender
- Age > 18 years on day of signing informed consent
- Informed written consent for participation in the study
- Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
- Hospitalized due to clinical instrumental diagnosis of pneumonia
Key exclusion criteria (3 listed)
- mechanical ventilation (both invasive and non-invasive)
- PaO2/FiO2<200
- known hypersensitivity to immunoglobulin or blood components
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, cured by COVID-19 and, after standard preparation and dosage of neutralizing antibodies, will be administered to patients with SARS-CoV2 pneumonia | Biological | Intervention |
Primary outcome
Need of invasive mechanical ventilation
Time frame: 30 days
Need of invasive mechanical ventilation defined as PaO2/FiO2 <150
5 secondary outcomes
Mortality rates
Time frame: 30 days
Time to invasive mechanical ventilation
Time frame: 30 days
Time to virologic cure
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
Adverse events
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Study was stopped because the Promoter was changed and a new study on convalescent plasma promoted by AIFA was started in Italy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Results publication: PubMed 32219428Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
- Individual participant dataSharing planned: No
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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.
Francesco Menichetti principal investigator
Azienda Ospedaliero, Universitaria Pisana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CONVALESCENT PLASMA in people with COVID and SARS-CoV 2, run by Azienda Ospedaliero, Universitaria Pisana at 1 site 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 3 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: stopped early, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was stopped because the Promoter was changed and a new study on convalescent plasma promoted by AIFA was started in Italy.). Results are not available in the source record.
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?
Need of invasive mechanical ventilation (time frame: 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 NCT04393727, 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 12 Nov 2020.