Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-03-05 @ 6:03 PM
Study NCT ID:
NCT04393727
Status:
TERMINATED
Last Update Posted:
2020-11-12
First Post:
2020-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transfusion of Convalescent Plasma for the Early Treatment of Patients With COVID-19
Sponsor:
Azienda Ospedaliero, Universitaria Pisana
Organization:
Study Overview
Official Title:
Transfusion of Convalescent Plasma for the Early Treatment of pneumonIa Due to SARSCoV2: a Multicenter Open Label Randomized Control Trial
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was stopped because the Promoter was changed and a new study on convalescent plasma promoted by AIFA was started in Italy.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TSUNAMI
Brief 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 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: