Convalescent Plasma Therapy for Hospitalized Patients With COVID-19

Tânia Portella Costa

Status and phase: Completed; Phase 2

Conditions: COVID-19; Convalescent Plasma; Respiratory Tract Diseases; Pneumonia; SARS-CoV-2; Coronavirus Infections

Treatments: Biological: Convalescent plasma; Drug: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT05077930

CCP TRIAL

Details and patient eligibility

About

Plasma from donors who have recovered from coronavirus disease 2019 (COVID-19) contain antibodies to SARS-CoV-2 and may be a potential therapy for hospitalized patients with COVID-19. The efficacy of high-titer convalescent plasma for COVID-19, however, still unclear. The present study aims to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with COVID-19.

Full description

This is an open-label, randomized controlled trial aimed to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with COVID-19. Participants must be adult hospitalized patients with a confirmed diagnosis of COVID-19 and time Between symptom onset and inclusion ≤ 7 days. Two hundred participants will be randomized in a 1:1 ratio to receive either 200-400 mL of high-titer COVID-19 convalescent plasma or standard care. The primary endpoint is the proportion of patients with clinical improvement at day 14 following randomization, defined by an increase of two points in the 7-point ordinal scale based on that recommended by the World Health Organization. Safety will be daily assessed by monitoring the occurrence of adverse effects and reactions to convalescent plasma transfusion. Study visits will occur on Day 1, Day 3, Day 7, and Day 14 or until hospital discharge, whichever comes first.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalized patients aged ≥18 years.
• Confirmed diagnosis of COVID-19 by RT-PCR or antigen test in respiratory samples.
• Time between symptom onset and inclusion ≤ 7 days.
• Enrolled within 5 days of hospitalization.
• Sign the consent form.

Exclusion criteria

• Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure.
• History of previous severe allergic reactions to transfused blood products.
• Limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator.
• Not currently enrolled another interventional clinical trial of COVID-19 treatment.
• Critically ill patient with COVID-19 being treated in intensive care.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Convalescent Plasma

Experimental group

Description:

The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Centro de Hematologia e Hemoterapia do Paraná - Hemepar following national blood donation guidelines and Brazilian Health Regulatory Agency (ANVISA) criteria. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined. Participants will receive the standard of care treatment and a single unit of convalescent plasma (volume=200 mL or 400 mL).

Treatment:

Biological: Convalescent plasma

Standard of care

Active Comparator group

Description:

Standard of care treatment according to the institutional protocol.

Treatment:

Drug: Standard of care