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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04393727
Recruitment Status : Terminated (Study was stopped because the Promoter was changed and a new study on convalescent plasma promoted by AIFA was started in Italy.)
First Posted : May 19, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Francesco Menichetti, Azienda Ospedaliero, Universitaria Pisana

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.


Condition or disease Intervention/treatment Phase
COVID SARS-CoV 2 Biological: CONVALESCENT PLASMA Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 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 SARSCoV2: a Multicenter Open Label Randomized Control Trial
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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



Primary Outcome Measures :
  1. Need of invasive mechanical ventilation [ Time Frame: 30 days ]
    Need of invasive mechanical ventilation defined as PaO2/FiO2 <150


Secondary Outcome Measures :
  1. Mortality rates [ Time Frame: 30 days ]
    Thirty-day mortality rates

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

  3. Time to virologic cure [ Time Frame: 30 days ]
    Days from randomization to virologic cure defined as 2 consecutive negative nasopharynx swabs

  4. Length of hospital stay [ Time Frame: 30 days ]
    Days from randomization to discharge or death

  5. Adverse events [ Time Frame: 30 days ]
    Occurrence of adverse events



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:

  • Any gender
  • Age > 18 years on day of signing informed consent
  • Informed written consent for participation in the study
  • Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
  • Hospitalized due to clinical instrumental diagnosis of pneumonia
  • PaO2/FiO2 ratio 200-350

Exclusion Criteria:

  • mechanical ventilation (both invasive and non-invasive)
  • PaO2/FiO2<200
  • known hypersensitivity to immunoglobulin or blood components

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): NCT04393727


Locations
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Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56124
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
Investigators
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Principal Investigator: Francesco Menichetti Azienda Ospedaliero, Universitaria Pisana
Publications of Results:
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Responsible Party: Francesco Menichetti, Professor, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier: NCT04393727    
Other Study ID Numbers: TSUNAMI
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Francesco Menichetti, Azienda Ospedaliero, Universitaria Pisana:
covid-19
SARS-CoV2
pneumonia
convalescent plasma