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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04716556
Recruitment Status : Completed
First Posted : January 20, 2021
Last Update Posted : August 26, 2021
Sponsor:
Collaborators:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Agenzia Italiana del Farmaco
Information provided by (Responsible Party):
Elena Toschi, Istituto Superiore di Sanità

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


Condition or disease Intervention/treatment Phase
Covid19 Coronavirus Infection Pneumonia, Viral Biological: Convalescent plasma Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa Due to SARS-CoV2 (TSUNAMI Study): a Multicenter Open Label Randomized Control Trial
Actual Study Start Date : July 16, 2020
Actual Primary Completion Date : January 14, 2021
Actual Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard Therapy+Convalescent Plasma
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
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

No Intervention: Standard Therapy
Patients will receive standard therapy for the treatment of SARS-CoV2 infection, according to AIFA indications



Primary Outcome Measures :
  1. Number of patients who meet invasive mechanical ventilation or death [ Time Frame: at 30 days ]
    Number of patients who meet invasive mechanical ventilation defined as PaO2/FiO2 <150 or death


Secondary Outcome Measures :
  1. Mortality rates [ Time Frame: 30 days ]
    Mortality rates at 30 days

  2. Time to invasive mechanical ventilation or death [ Time Frame: 30 days ]
    Days from randomization to invasive mechanical ventilation or death

  3. Time to virologic recover [ Time Frame: 30 days ]
    Days from randomization to virologic recover (defined as 2 consecutive negative nasopharynx tests)

  4. Hospitalization time [ Time Frame: 30 days ]
  5. Adverse events [ Time Frame: 30 days ]
    occurrence of Adverse events


Other Outcome Measures:
  1. Evaluation of CD4/CD8 ratio [ Time Frame: 14 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT04716556


Locations
Show Show 48 study locations
Sponsors and Collaborators
Istituto Superiore di Sanità
Gruppo Italiano Malattie EMatologiche dell'Adulto
Agenzia Italiana del Farmaco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elena Toschi, Research Coordinator, Istituto Superiore di Sanità
ClinicalTrials.gov Identifier: NCT04716556    
Other Study ID Numbers: TSUNAMI
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elena Toschi, Istituto Superiore di Sanità:
plasma
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Coronavirus Infections
Pneumonia, Viral
Respiratory Tract Infections
Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases