Treatment of Patients With COVID-19 With Convalescent Plasma

COVID-19 Clinical Trial

— COOPCOVID-19  

Official title:

Treatment of Patients With COVID-19 With Convalescent Plasma Transfusion: a Multicenter, Open-labeled, Randomized and Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04415086
• Other study ID #: COOP-COVID-19-MCTIC
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: February 15, 2022

Study information

• Verified date: October 2021
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• convalescent 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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo - General Hospital	São Paulo	SP

Sponsors (8)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Faculty of Medicine of Ribeirão Preto (FMRP-USP), Grupo Hospitalar Conceição, Hospital de Clínicas, Faculdade de Medicina Universidade Estadual de Campinas, Hospital Ernesto Dornelles, Hospital Israelita Albert Einstein, Hospital Sirio-Libanes, Ministério da Ciência, Tecnologia, Inovações e Comunicações

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time elapsed until clinical improvement or hospital discharge	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)	Follow up until 28 days after transfusion
Secondary	acute adverse events	incidence of acute adverse events possibly or definitively realted to convalescent plasma transfusion	Up to 12 hours after transfusion
Secondary	Clinical Status	Evaluation according to an ordinal scale of 10 categories	"Day 7", "Day 14" and "Day 28"
Secondary	Duration of clinical events	Duration of mechanical ventilation, length of hospital stay in survivors up to 28 days and time from the beginning of treatment to death	Up to 28 days
Secondary	SARS-CoV-2 in nasopharyngeal swab	Detection of SARS-CoV-2 in nasopharyngeal swab	Days 0, 1, 3, 7, 14 and 28 after transfusion and control groups
Secondary	IgG, IgM and IgA titers for SARS-CoV-2	Specific IgG, IgM and IgA titers for SARS-CoV-2	Days 0, 1, 3, 5, 7, 14 and 28 after transfusion and control groups
Secondary	Neutralizing antibodies	Titers of neutralizing antibodies	0,1,7 14 and 28 days after transfusion and control groups