Clinical trial NCT04415086: Treatment of Patients With COVID-19 With Convalescent Plasma
Official title: Treatment of Patients With COVID-19 With Convalescent Plasma Transfusion: a Multicenter, Open-labeled, Randomized and Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19
convalescent plasma
efficacy
safety
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Ministério da Ciência, Tecnologia, Inovações e Comunicações
name: Faculty of Medicine of Ribeirão Preto (FMRP-USP)
name: Hospital de Clínicas, Faculdade de Medicina Universidade Estadual de Campinas
name: Hospital Sirio-Libanes
name: Hospital Israelita Albert Einstein
name: Grupo Hospitalar Conceição
name: Hospital Ernesto Dornelles
First posted: 2020-06-04
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time elapsed until clinical improvement or hospital discharge
timeFrame: Follow up until 28 days after transfusion
Secondary outcomes:
measure: acute adverse events
timeFrame: Up to 12 hours after transfusion
measure: Clinical Status
timeFrame: "Day 7", "Day 14" and "Day 28"
measure: Duration of clinical events
timeFrame: Up to 28 days
measure: SARS-CoV-2 in nasopharyngeal swab
timeFrame: Days 0, 1, 3, 7, 14 and 28 after transfusion and control groups
measure: IgG, IgM and IgA titers for SARS-CoV-2
timeFrame: Days 0, 1, 3, 5, 7, 14 and 28 after transfusion and control groups
measure: Neutralizing antibodies
timeFrame: 0,1,7 14 and 28 days after transfusion and control groups
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo - General Hospital
state: SP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Esper G Kallás, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song ATW, Rocha V, Mendrone-Junior A, Calado RT, De Santis GC, Benites BD, Costa-Lima C, Vargas T, Marques LS, Fernandes JC, Breda FC, Wendel S, Fachini R, Rizzo LV, Kutner JM, Avelino-Silva VI, Machado RRG, Durigon EL, Chevret S, Kallas EG. Treatment of severe COVID-19 patients with either low- or high-volume of convalescent plasma versus standard of care: A multicenter Bayesian randomized open-label clinical trial (COOP-COVID-19-MCTI). Lancet Reg Health Am. 2022 Jun;10:100216. doi: 10.1016/j.lana.2022.100216. Epub 2022 Mar 15.