Convalescent Plasma
BiologicalConvalescent 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
NCT Number: NCT04716556
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
SOD Clinica Malattie Infettive Tropicali, Parassitologia, Epatiti Croniche - AOU Ospedali Riuniti di Ancona, Ancona, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: at 30 days
Number of patients who meet invasive mechanical ventilation defined as PaO2/FiO2 <150 or death
Time frame: 30 days
Mortality rates at 30 days
Time frame: 30 days
Days from randomization to invasive mechanical ventilation or death
Time frame: 30 days
Days from randomization to virologic recover (defined as 2 consecutive negative nasopharynx tests)
Time frame: 30 days
Time frame: 30 days
occurrence of Adverse events
Time frame: 14 days
Istituto Superiore di Sanità
Other
TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa Due to SARS-CoV2 (TSUNAMI Study): a Multicenter Open Label Randomized Control Trial
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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