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Treatment of Patients With COVID-19 With Convalescent Plasma (COOPCOVID-19)

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
convalescent plasma
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, convalescent plasma, efficacy, safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Sao Paulo - General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

Participants will receive the standard of care treatment

Participants will receive the standard treatment and convalescent plasma in a volume of 200ml (150-300ml)

Participants will receive the standard treatment and convalescent plasma in a volume of 400ml (300-600ml)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

acute adverse events
incidence of acute adverse events possibly or definitively realted to convalescent plasma transfusion
Clinical Status
Evaluation according to an ordinal scale of 10 categories
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
SARS-CoV-2 in nasopharyngeal swab
Detection of SARS-CoV-2 in nasopharyngeal swab
IgG, IgM and IgA titers for SARS-CoV-2
Specific IgG, IgM and IgA titers for SARS-CoV-2
Neutralizing antibodies
Titers of neutralizing antibodies

Full Information

First Posted
June 1, 2020
Last Updated
May 17, 2022
Sponsor
University of Sao Paulo General Hospital
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT04415086
Brief Title
Treatment of Patients With COVID-19 With Convalescent Plasma
Acronym
COOPCOVID-19
Official Title
Treatment of Patients With COVID-19 With Convalescent Plasma Transfusion: a Multicenter, Open-labeled, Randomized and Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, convalescent plasma, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Sham Comparator
Arm Description
Participants will receive the standard of care treatment
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Participants will receive the standard treatment and convalescent plasma in a volume of 200ml (150-300ml)
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Participants will receive the standard treatment and convalescent plasma in a volume of 400ml (300-600ml)
Intervention Type
Biological
Intervention Name(s)
convalescent plasma
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time elapsed until clinical improvement or hospital discharge
Description
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)
Time Frame
Follow up until 28 days after transfusion
Secondary Outcome Measure Information:
Title
acute adverse events
Description
incidence of acute adverse events possibly or definitively realted to convalescent plasma transfusion
Time Frame
Up to 12 hours after transfusion
Title
Clinical Status
Description
Evaluation according to an ordinal scale of 10 categories
Time Frame
"Day 7", "Day 14" and "Day 28"
Title
Duration of clinical events
Description
Duration of mechanical ventilation, length of hospital stay in survivors up to 28 days and time from the beginning of treatment to death
Time Frame
Up to 28 days
Title
SARS-CoV-2 in nasopharyngeal swab
Description
Detection of SARS-CoV-2 in nasopharyngeal swab
Time Frame
Days 0, 1, 3, 7, 14 and 28 after transfusion and control groups
Title
IgG, IgM and IgA titers for SARS-CoV-2
Description
Specific IgG, IgM and IgA titers for SARS-CoV-2
Time Frame
Days 0, 1, 3, 5, 7, 14 and 28 after transfusion and control groups
Title
Neutralizing antibodies
Description
Titers of neutralizing antibodies
Time Frame
0,1,7 14 and 28 days after transfusion and control groups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esper G Kallás, PhD, MD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo - General Hospital
City
São Paulo
State/Province
SP
ZIP/Postal Code
01403-002
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35308034
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.
Results Reference
derived

Learn more about this trial

Treatment of Patients With COVID-19 With Convalescent Plasma

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