COVID-19
Conditions
Keywords
COVID-19, convalescent plasma, efficacy, safety
Brief summary
The COVID-19 pandemic has been spreading continuously, and in Brazil, until May 31, 2020, there have been more than 450.000 cases with more than 28.000 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of convalescent plasma in treatment of severe cases of COVID-19 in a multicenter, randomized, open-label and controlled study
Detailed description
Eligible patients will be randomized 1:1:1 into 3 treatment groups: A- standard (control); B- standard and convalescent plasma in a volume of 200ml (150-300ml); C- standard and convalescent plasma in a volume of 400ml (300-600ml). The Bayesian multi-arm and multi-stage model will be used, which will allow an interim analysis after the inclusion of 30 patients, with repeated interim analyses for every 30 additional patients. With this, we expect to define not only the efficacy of convalescent plasma, but also the volume of plasma needed if efficacy is proven. The study will be interrupted if the efficacy of the convalescent plasma group is proven, so that all severely ill patients as defined in the study can receive the convalescent plasma treatment. The same will occur if there is no difference in primary outcome with the use of convalescent plasma or serious adverse effects.
Interventions
BIOLOGICALconvalescent plasma
The study will be interrupted if the efficacy of the convalescent plasma group is proven, so that all severely ill patients as defined in the study can receive the convalescent plasma treatment. The same will occur if there is no difference in primary outcome with the use of convalescent plasma or serious adverse effects.
Sponsors
Ministério da Ciência, Tecnologia, Inovações e Comunicações
Faculty of Medicine of Ribeirão Preto (FMRP-USP)
Hospital de Clínicas, Faculdade de Medicina Universidade Estadual de Campinas
Hospital Sirio-Libanes
Hospital Israelita Albert Einstein
Grupo Hospitalar Conceição
Hospital Ernesto Dornelles
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1:1 into 3 treatment groups: A- standard (control); B- standard and convalescent plasma in a volume of 200ml (150-300ml); C- standard and convalescent plasma in a volume of 400ml (300-600ml)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age = or \> than 18 years; . * Laboratory-proven COVID-19 infection by RT-PCR in any clinical sample . Time since symptom onset less than 10 days at the time of screening; - . Presence of COVID-19 pneumonia, with a typical, indeterminate or atypical compatible image in a chest tomography exam (see definition below) - * Presence of one of the following criteria: * Need for\> 3L of O2 in the catheter / mask or\> 25% in the Venturi mask to maintain O2 saturation\> 92% B presence of respiratory distress syndrome with PaO2 / FiO2 \<300mmHg If intubated, within 48 hours of orotracheal intubation * Absence of a history of serious adverse reactions to transfusion, for example, anaphylaxis; - .Participation approval by the research clinician
Exclusion criteria
* Already enrolled in another clinical trial evaluating antiviral or immunobiological therapy for the treatment of COVID-19. * IgA deficiency * Presence of a clinical condition that does not allow infusion of 400 ml of volume at clinical discretion * Pregnancy or breastfeeding * Receipt of immunoglobulin in the last 30 days * Presence of significant risk of death within the next 48 hours at clinical discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time elapsed until clinical improvement or hospital discharge | Follow up until 28 days after transfusion | clinical improvement is defined as the time from the randomization date until the decline of 2 categories on the ordinal scale of 10 categories or hospital discharge (whichever comes first) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Status | Day 7, Day 14 and Day 28 | Evaluation according to an ordinal scale of 10 categories |
| Duration of clinical events | Up to 28 days | Duration of mechanical ventilation, length of hospital stay in survivors up to 28 days and time from the beginning of treatment to death |
| acute adverse events | Up to 12 hours after transfusion | incidence of acute adverse events possibly or definitively realted to convalescent plasma transfusion |
| IgG, IgM and IgA titers for SARS-CoV-2 | Days 0, 1, 3, 5, 7, 14 and 28 after transfusion and control groups | Specific IgG, IgM and IgA titers for SARS-CoV-2 |
| Neutralizing antibodies | 0,1,7 14 and 28 days after transfusion and control groups | Titers of neutralizing antibodies |
| SARS-CoV-2 in nasopharyngeal swab | Days 0, 1, 3, 7, 14 and 28 after transfusion and control groups | Detection of SARS-CoV-2 in nasopharyngeal swab |
Countries
Brazil
Outcome results
None listed