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Completed

NCT Number: NCT04716556

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SOD Clinica Malattie Infettive Tropicali, Parassitologia, Epatiti Croniche - AOU Ospedali Riuniti di Ancona, Ancona, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Convalescent Plasma

Biological

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

Primary outcomes

  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 outcomes

  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 outcomes

  1. Evaluation of CD4/CD8 ratio

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Istituto Superiore di Sanità

Other

Collaborators

  • Agenzia Italiana del Farmaco
  • Gruppo Italiano Malattie EMatologiche dell'Adulto

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2021
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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