Convalescent Plasma Therapy for Hospitalized Patients With COVID-19

COVID-19 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077930
• Other study ID #: CCP TRIAL
• Status: Completed
• Phase: Phase 2
• Start date: January 6, 2022
• Est. completion date: April 7, 2022

Study information

• Verified date: November 2023
• Source: Science Valley Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 7, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Biological:
• 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.

Drug:
• Standard of care
The active comparator group will receive oxygen supplementation, corticoids, antiretrovirals, and/or monoclonal antibodies according to the institutional protocol.

Locations

Country	Name	City	State
Brazil	Maternidade e Cirurgia Nossa Senhora do Rocio/ SA - Hospital do Rocio	Campo Largo	Paraná

Sponsors (4)

Lead Sponsor	Collaborator
Tânia Portella Costa	Centro de Hematologia e Hemoterapia do Paraná - Hemepar, Fundação Oswaldo Cruz, Instituto Carlos Chagas, ICC Paraná, Science Valley Research Institute

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association between the presence of comorbidities at baseline and clinical status on a 7-point ordinal scale	Association between patients' clinical status assessed by a 7-point ordinal scale from World Health Organization (WHO) on Day 14 after randomization and baseline characteristics and history or comorbidities known at high risk for COVID-19 (age, sex, obesity - body mass index >30 kg/m², history of hypertension, chronic heart disease, congestive heart failure, chronic bronchopulmonary disease, diabetes mellitus, and immunosuppression).; Lower scores in this scale 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, IMV, or both; (7), death.	Day 1 and Day 14 after randomization
Other	Association between the volume of convalescent plasma transfused and clinical status on a 7-point ordinal scale	Association between patients' clinical status assessed by a 7-point ordinal scale from World Health Organization (WHO) on Day 14 after randomization and the volume of a single unit of convalescent plasma transfused (200 mL or 400 mL). Lower scores in this scale 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, IMV, or both; (7), death.	Day 1 and Day 14 after randomization
Other	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
Other	Association between the concentration of inflammatory surrogate markers and clinical status on a 7-point ordinal scale	Association between patients' clinical status assessed by a 7-point ordinal scale from World Health Organization (WHO) on Day 14 after randomization and inflammatory surrogate markers, which include white blood counts, lymphocyte counts, C-reactive protein (CRP) and D-dimer levels. Lower scores in this scale 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, IMV, or both; (7), death.	Day 14 after randomization
Primary	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	Percentage of participants at each clinical status on a 7-point ordinal scale	Measure of patients' clinical status using an ordinal scale for clinical improvement created by World Health Organization (WHO) and based on 7-point scale categories. Lower scores in this scale 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, IMV, or both; (7), death.	Day 1, Day 3, Day 7, and Day 14 after randomization
Secondary	Oxygen saturation		Day 1, Day 3, Day 7, and Day 14 after randomization
Secondary	Prevalence of oxygen-intake methods	Percentage of participants using oxygen by mask or nasal prongs, oxygen by non-invasive ventilation or high flow, intubation & mechanical ventilation and ECMO.	Day 1, Day 3, Day 7, and Day 14 after randomization
Secondary	Respiratory rate		Day 1, Day 3, Day 7, and Day 14 after randomization
Secondary	The PaO2 / FiO2 ratio (for patients on mechanical mechanisms)		Day 1, Day 3, Day 7, and Day 14 after randomization
Secondary	Number and /or extension of affected lung areas on chest computed tomography		Day 1, Day 3, Day 7, and Day 14 after randomization
Secondary	Length of hospital stay		Day 1, Day 3, Day 7, and Day 14 after randomization
Secondary	Length of stay in intensive care		Day 1, Day 3, Day 7, and Day 14 after randomization
Secondary	Time until independence from oxygen therapy in days		Day 1, Day 3, Day 7, and Day 14 after randomization
Secondary	Ventilator free days		Day 1, Day 3, Day 7, and Day 14 after randomization
Secondary	In patients who needed mechanical ventilation, time to initiate mechanical ventilation (calculated in days, from entry into the protocol until orotracheal intubation)		Day 1, Day 3, Day 7, and Day 14 after randomization
Secondary	Rate of transfusion reactions to convalescent plasma infusion		Daily, until Day 14 after randomization
Secondary	Percentage of participants who develop serious adverse events and adverse events considered as definitely or probably associated with plasma transfusion	Adverse events (worsening anemia, urticaria, skin rash, transfusion-associated circulatory overload, and others) assessed during hospitalization.	Daily, until Day 14 after randomization

External Links

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