Convalescent Plasma Therapy for Hospitalized Patients With COVID-19

NCT05077930 | Completed Phase 2 DMC

• 1 other identifier: CCP TRIAL
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Clinical status on a 7-point ordinal scale

  Patients' clinical status over time assessed by a 7-point ordinal scale from World Health Organization (WHO). Lower scores are seen with better clinical outcomes. The scale categories are as follows: (1), not hospitalized with resumption of normal activities; (2), not hospitalized, but unable to resume normal activities; (3), hospitalized, not requiring supplemental oxygen; (4), hospitalized, requiring supplemental oxygen; (5), hospitalized, requiring high-flow oxygen therapy or noninvasive mechanical ventilation; (6), hospitalized, requiring ECMO (extracorporeal membrane oxygenation), IMV (intermittent mandatory ventilation), or both; (7), death. Proportion of patients with clinical improvement, defined by an increase of two points in the ordinal scale of seven WHO categories.

  From randomization to end of study at Day 14

Secondary Outcomes (13)

• Percentage of participants at each clinical status on a 7-point ordinal scale

  Day 1, Day 3, Day 7, and Day 14 after randomization

• Oxygen saturation

  Day 1, Day 3, Day 7, and Day 14 after randomization

• Prevalence of oxygen-intake methods

  Day 1, Day 3, Day 7, and Day 14 after randomization

• Respiratory rate

  Day 1, Day 3, Day 7, and Day 14 after randomization

• The PaO2 / FiO2 ratio (for patients on mechanical mechanisms)

  Day 1, Day 3, Day 7, and Day 14 after randomization

Other Outcomes (4)

• Association between the presence of comorbidities at baseline and clinical status on a 7-point ordinal scale

  Day 1 and Day 14 after randomization

• Association between the volume of convalescent plasma transfused and clinical status on a 7-point ordinal scale

  Day 1 and Day 14 after randomization

• Changes from baseline in inflammatory surrogate markers: white blood counts, lymphocyte counts, C-reactive protein (CRP) and D-dimer levels

  Day 1 and Day 14 after randomization

Study Arms (2)

Convalescent Plasma

EXPERIMENTAL

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).

Biological: Convalescent plasma

Standard of care

ACTIVE COMPARATOR

Standard of care treatment according to the institutional protocol.

Drug: Standard of care

Interventions

Convalescent plasma 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.

Convalescent Plasma

Standard of care DRUG

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

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tânia Portella Costa: lead
• Centro de Hematologia e Hemoterapia do Paraná - Hemepar: collaborator
• Fundação Oswaldo Cruz, Instituto Carlos Chagas, ICC Paraná: collaborator
• Science Valley Research Institute: collaborator

Study Sites (1)

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

Campo Largo, Paraná, 83606-177, Brazil

Location

Related Publications (2)

• 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.

  PMID: 32648959 BACKGROUND

• 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.

  PMID: 39383382 DERIVED

Related Links

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

MeSH Terms

Conditions

COVID-19; Pneumonia; Coronavirus Infections; Respiratory Tract Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kengi Itinose, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Tânia Portella Costa - Maternidade e Cirurgia Nossa Senhora do Rocio/ SA - Hospital do Rocio

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

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 14, 2021
• Study Start: January 6, 2022
• Primary Completion: April 4, 2022
• Study Completion: April 7, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

BR (1)