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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04415086
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : October 29, 2020
Sponsor:
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
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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

Condition or disease Intervention/treatment Phase
COVID-19 Biological: convalescent plasma Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Patients With COVID-19 With Convalescent Plasma Transfusion: a Multicenter, Open-labeled, Randomized and Controlled Study
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : April 20, 2022
Estimated Study Completion Date : May 22, 2022

Arm Intervention/treatment
Sham Comparator: Group A
Participants will receive the standard of care treatment
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.

Active Comparator: Group B
Participants will receive the standard treatment and convalescent plasma in a volume of 200ml (150-300ml)
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.

Active Comparator: Group C
Participants will receive the standard treatment and convalescent plasma in a volume of 400ml (300-600ml)
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.




Primary Outcome Measures :
  1. Time elapsed until clinical improvement or hospital discharge [ Time Frame: 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 Outcome Measures :
  1. acute adverse events [ Time Frame: Up to 12 hours after transfusion ]
    incidence of acute adverse events possibly or definitively realted to convalescent plasma transfusion

  2. Clinical Status [ Time Frame: "Day 7", "Day 14" and "Day 28" ]
    Evaluation according to an ordinal scale of 10 categories

  3. Duration of clinical events [ Time Frame: 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

  4. SARS-CoV-2 in nasopharyngeal swab [ Time Frame: Days 0, 1, 3, 7, 14 and 28 after transfusion and control groups ]
    Detection of SARS-CoV-2 in nasopharyngeal swab

  5. 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 ]
    Specific IgG, IgM and IgA titers for SARS-CoV-2

  6. Neutralizing antibodies [ Time Frame: 0,1,7 14 and 28 days after transfusion and control groups ]
    Titers of neutralizing antibodies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04415086


Contacts
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Contact: Zelinda B Nakagawa, MsC 55-11-2661-7214 zelinda.bartolomei@gmail.com
Contact: Natália B Cerqueira 55-112661-2277 natalia.b.cerqueira@gmail.com

Locations
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Brazil
University of Sao Paulo - General Hospital Recruiting
São Paulo, SP, Brazil, 01403-002
Contact: Zelinda Maria B Nakagawa    11999799251    zelinda.bartolomei@gmail.com   
Contact: Denivalda SG Araujo    11977639302    deni.gomes.araujo@gmail.com   
Principal Investigator: Esper G Kallas, PhD MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
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
Investigators
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Principal Investigator: Esper G Kallás, PhD, MD University of Sao Paulo General Hospital
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04415086    
Other Study ID Numbers: COOP-COVID-19-MCTIC
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
COVID-19
convalescent plasma
efficacy
safety