Transfusion of Convalescent Plasma for the Early Treatment of Patients With COVID-19 (TSUNAMI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04393727|
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 20, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID SARS-CoV 2||Biological: CONVALESCENT PLASMA||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transfusion of Convalescent Plasma for the Early Treatment of pneumonIa Due to SARSCoV2: a Multicenter Open Label Randomized Control Trial|
|Actual Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||October 30, 2020|
Patients in the intervention group will receive 200 cc of convalescent plasma
Biological: CONVALESCENT PLASMA
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
No Intervention: Control
Patients will continue to receive standard therapy
- Need of invasive mechanical ventilation [ Time Frame: 30 days ]Need of invasive mechanical ventilation defined as PaO2/FiO2 <150
- Mortality rates [ Time Frame: 30 days ]Thirty-day mortality rates
- Time to invasive mechanical ventilation [ Time Frame: 30 days ]Days from randomization to invasive mechanical ventilation
- Time to virologic cure [ Time Frame: 30 days ]Days from randomization to virologic cure defined as 2 consecutive negative nasopharynx swabs
- Length of hospital stay [ Time Frame: 30 days ]Days from randomization to discharge or death
- Adverse events [ Time Frame: 30 days ]Occurrence of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393727
|Contact: Marco Falconeemail@example.com|
|Azienda Ospedaliero Universitaria Pisana||Recruiting|
|Pisa, Italy, 56124|
|Contact: Marco Falcone firstname.lastname@example.org|
|Principal Investigator: Francesco Menichetti|
|Sub-Investigator: Marco Falcone|
|Principal Investigator:||Francesco Menichetti||Azienda Ospedaliero, Universitaria Pisana|