COVID-19 Convalescent Plasma Therapy (TPCC)

Universidad Nacional de Asunción

Status and phase: Completed; Phase 3; Phase 2

Conditions: SARS-CoV-2 Infection; COVID-19 Infection

Treatments: Biological: Convalescent plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04747158

PINV20-388

Details and patient eligibility

About

This study is an open-label trial in which hospitalized patients with risk factors of severe coronavirus disease 2019 [COVID-19] will be receive treatment with convalescent plasma (≤ 15 days from symptoms start).

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 Years and older
• Presence of risk factors of severe COVID 19 diagnosed by quantitative polymerase chain reaction by reverse transcription (RT-qPCR)
• Patients with no more than 15 days from the onset of symptoms
• Signed informed consent

Exclusion criteria

• Severely ill patients admitted directly to the ICU.
• Need for mechanical ventilation at the time of hospital admission, regardless of the time of clinical evolution.
• History of previous hypersensitivity to plasma transfusions.
• History of immunoglobulin A (IgA) deficiency
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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350 participants in 1 patient group

Convalescent plasma

Experimental group

Description:

COVID-19 convalescent plasma

Treatment:

Biological: Convalescent plasma