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

TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa Due to SARS-CoV2 (TSUNAMI Study): a Multicenter Open Label Randomized Control Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04716556

Enrollment

474

Registered

2021-01-20

Start date

2020-07-16

Completion date

2021-05-31

Last updated

2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infection, Covid19, Pneumonia, Viral

Keywords

plasma

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

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.

Interventions

BIOLOGICALConvalescent 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Hospitalization time	30 days	—
Adverse events	30 days	occurrence of Adverse events
Time to virologic recover	30 days	Days from randomization to virologic recover (defined as 2 consecutive negative nasopharynx tests)

Other

Measure	Time frame
Evaluation of CD4/CD8 ratio	14 days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026