Clinical trial NCT05077930: Convalescent Plasma Therapy for Hospitalized Patients With COVID-19
Official title: Validation Protocol for The Clinical Use of Convalescent Plasma for Hospitalized Patients With COVID-19. A Prospective Study at a Hospital in Southern Brazil.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Convalescent Plasma
SARS-CoV-2
Pneumonia
Coronavirus Infections
Respiratory Tract Diseases
Lead sponsor: Science Valley Research Institute
Sponsor class: OTHER
Collaborators: name: Centro de Hematologia e Hemoterapia do Paraná - Hemepar
name: Fundação Oswaldo Cruz, Instituto Carlos Chagas, ICC Paraná
name: Science Valley Research Institute
First posted: 2021-10-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an open-label, randomized study design (1: 1), controlled trial, in hospitalized patients with COVID-19.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical status on a 7-point ordinal scale
timeFrame: From randomization to end of study at Day 14
Secondary outcomes:
measure: Percentage of participants at each clinical status on a 7-point ordinal scale
timeFrame: Day 1, Day 3, Day 7, and Day 14 after randomization
measure: Oxygen saturation
timeFrame: Day 1, Day 3, Day 7, and Day 14 after randomization
measure: Prevalence of oxygen-intake methods
timeFrame: Day 1, Day 3, Day 7, and Day 14 after randomization
measure: Respiratory rate
timeFrame: Day 1, Day 3, Day 7, and Day 14 after randomization
measure: The PaO2 / FiO2 ratio (for patients on mechanical mechanisms)
timeFrame: Day 1, Day 3, Day 7, and Day 14 after randomization
measure: Number and /or extension of affected lung areas on chest computed tomography
timeFrame: Day 1, Day 3, Day 7, and Day 14 after randomization
measure: Length of hospital stay
timeFrame: Day 1, Day 3, Day 7, and Day 14 after randomization
measure: Length of stay in intensive care
timeFrame: Day 1, Day 3, Day 7, and Day 14 after randomization
measure: Time until independence from oxygen therapy in days
timeFrame: Day 1, Day 3, Day 7, and Day 14 after randomization
measure: Ventilator free days
timeFrame: Day 1, Day 3, Day 7, and Day 14 after randomization
measure: In patients who needed mechanical ventilation, time to initiate mechanical ventilation (calculated in days, from entry into the protocol until orotracheal intubation)
timeFrame: Day 1, Day 3, Day 7, and Day 14 after randomization
measure: Rate of transfusion reactions to convalescent plasma infusion
timeFrame: Daily, until Day 14 after randomization
measure: Percentage of participants who develop serious adverse events and adverse events considered as definitely or probably associated with plasma transfusion
timeFrame: Daily, until Day 14 after randomization
Other outcomes:
measure: Association between the presence of comorbidities at baseline and clinical status on a 7-point ordinal scale
timeFrame: Day 1 and Day 14 after randomization
measure: Association between the volume of convalescent plasma transfused and clinical status on a 7-point ordinal scale
timeFrame: Day 1 and Day 14 after randomization
measure: Changes from baseline in inflammatory surrogate markers: white blood counts, lymphocyte counts, C-reactive protein (CRP) and D-dimer levels
timeFrame: Day 1 and Day 14 after randomization
measure: Association between the concentration of inflammatory surrogate markers and clinical status on a 7-point ordinal scale
timeFrame: Day 14 after randomization
Locations:
city: Campo Largo
country: Brazil
facility: Maternidade e Cirurgia Nossa Senhora do Rocio/ SA - Hospital do Rocio
state: Paraná
Study officials:
affiliation: Maternidade e Cirurgia Nossa Senhora do Rocio/ SA - Hospital do Rocio
name: Kengi Itinose, MD
role: STUDY_DIRECTOR
References:
citation: 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.