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Convalescent Plasma Therapy for Hospitalized Patients With COVID-19

NCT ID: NCT05077930

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-06

Study Completion Date

2022-04-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is an open-label, randomized study design (1: 1), controlled trial, in hospitalized patients with COVID-19.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Convalescent Plasma

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).

Group Type EXPERIMENTAL

Convalescent plasma

Intervention Type BIOLOGICAL

The intervention group will receive 200 or 400 mL of high-titer COVID-19 convalescent plasma, ABO compatible with the patient, within 24 hours of randomization.

Standard of care

Standard of care treatment according to the institutional protocol.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type DRUG

The active comparator group will receive oxygen supplementation, corticoids, antiretrovirals, and/or monoclonal antibodies according to the institutional protocol.

Interventions

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Convalescent plasma

The intervention group will receive 200 or 400 mL of high-titer COVID-19 convalescent plasma, ABO compatible with the patient, within 24 hours of randomization.

Intervention Type BIOLOGICAL

Standard of care

The active comparator group will receive oxygen supplementation, corticoids, antiretrovirals, and/or monoclonal antibodies according to the institutional protocol.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro de Hematologia e Hemoterapia do Paraná - Hemepar

UNKNOWN

Sponsor Role collaborator

Fundação Oswaldo Cruz, Instituto Carlos Chagas, ICC Paraná

UNKNOWN

Sponsor Role collaborator

Science Valley Research Institute

OTHER

Sponsor Role collaborator

Tânia Portella Costa

OTHER

Sponsor Role lead

Responsible Party

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Tânia Portella Costa

Tânia Portella Costa - Maternidade e Cirurgia Nossa Senhora do Rocio/ SA - Hospital do Rocio

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kengi Itinose, MD

Role: STUDY_DIRECTOR

Maternidade e Cirurgia Nossa Senhora do Rocio/ SA - Hospital do Rocio

Locations

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Maternidade e Cirurgia Nossa Senhora do Rocio/ SA - Hospital do Rocio

Campo Largo, Paraná, Brazil

Site Status

Countries

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Brazil

References

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Piechotta V, Chai KL, Valk SJ, Doree C, Monsef I, Wood EM, Lamikanra A, Kimber C, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Jul 10;7(7):CD013600. doi: 10.1002/14651858.CD013600.pub2.

Reference Type BACKGROUND
PMID: 32648959 (View on PubMed)

Costa TP, Aoki M, Ribeiro CM, Socca E, Itinose L, Basso R, Blanes L. Efficacy of convalescent plasma in hospitalized COVID-19 patients: findings from a controlled trial. Braz J Med Biol Res. 2024 Oct 7;57:e13627. doi: 10.1590/1414-431X2024e13627. eCollection 2024.

Reference Type DERIVED
PMID: 39383382 (View on PubMed)

Related Links

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https://www.comet-initiative.org/assets/downloads/COVID-19%20meta%20COS_Table%201_15th%20March%202021.pdf

Core Outcome Set (COS) for studies of any intervention in hospitalised patients with confirmed or suspected COVID-19

Other Identifiers

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CCP TRIAL

Identifier Type: -

Identifier Source: org_study_id