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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19, Coronavirus Infection, Pneumonia, Viral

Intervention / Treatment
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* Biological: Convalescent plasma


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Therapy+Convalescent Plasma<br>Patients will receive standard therapy + 200-300 ml of convalescent plasma for a maximum of 3 times in 5 days, according to clinical conditions. | Biological: Convalescent plasma<br>* 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<br>|
| No Intervention: Standard Therapy<br>Patients will receive standard therapy for the treatment of SARS-CoV2 infection, according to AIFA indications | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rates | Mortality rates at 30 days | 30 days | 
| Time to invasive mechanical ventilation or death | Days from randomization to invasive mechanical ventilation or death | 30 days | 
| Time to virologic recover | Days from randomization to virologic recover (defined as 2 consecutive negative nasopharynx tests) | 30 days | 
| Hospitalization time |  | 30 days | 
| Adverse events | occurrence of Adverse events | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plasma