Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Convalescent plasma
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Convalescent plasma, SARS-CoV-2
Eligibility Criteria
Recipient Inclusion Criteria:
- Confirmed diagnosis of COVID-19 by RT-PCR;
- Time between symptom onset and inclusion ≤ 7 days;
- Chest tomography with <50% involvement of the lung parenchyma;
- No indication of ventilatory support at the time of randomization;
- Sign the consent form.
Recipient Exclusion Criteria:
- Contraindication to transfusion or history of previous reactions to blood products for transfusion;
- Pregnant women;
- Limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator.
Donor Inclusion Criteria for Plasmapheresis:
- Convalescent plasma donation will be eligible for patients ≥ 18 years old who had previously confirmed COVID-19 by RT-PCR, which met the criteria adopted by technical notes n13 and 21/2020-CGSH/DAET/SAES/MS;
- SARS-COV-2 negative RT-PCR;
- Asymptomatic for at least 14 days;
- SARS-CoV-2 anti-peak titre with dilution ≥ 1: 320;
- Sign the consent form.
Donor Exclusion Criteria:
- Female gender with previous pregnancy;
- Absence of peripheral venous network compatible with the apheresis procedure;
- Positive or indeterminate result in any of the infectious screening tests;
- Presence of intellectual incapacity to understand the guidelines regarding the risks and benefits of participating in the study.
Sites / Locations
- D'Or Institute for Research and EducationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Convalescent Plasma + Standard treatment
Standard treatment
Arm Description
Participants will receive the standard treatment and convalescent plasma
Participants will receive the standard treatment
Outcomes
Primary Outcome Measures
Area under the curve of SARS-COV-2 viral load obtained from nasopharyngeal and /or oropharyngeal swabs.
To evaluate the area under the curve of SARSCoV-2 viral load in nasopharyngeal and or oropharyngeal samples on days 0, 3, 6, 9, 12, 15, 18 and 15 after randomization.
Secondary Outcome Measures
Assessment of clinical improvement using an Ordinal Severity Scale
The seven-point scale is as follows:
Death 7 points;
Hospital admission for mechanical ventilation plus additional organ support (eg, pressors, RRT, ECMO) = 6 points;
Hospital admission for mechanical ventilation = 5 points;
Hospital admission for non-invasive ventilation or high-flow oxygen therapy = 4 points;
Hospital admission for oxygen therapy (but not requiring high-flow or non-invasive ventilation) = 3 points;
Hospital admission but not requiring oxygen therapy = 2 points;
Discharged with limitations of activities = 1 point;
Discharged with no limitations of activities = 0 point;
Evaluate oxygen saturation
Evaluate oxygen supplementation
Assess respiratory rate
Evaluate the PaO2 / FiO2 ratio (for patients on mechanical mechanisms)
Length of hospital stay
Length of stay in intensive care
Assess the rate of orotracheal intubation
Change in the profile of cytokines/chemokines in both groups
Quantification by ELISA the levels of 36 molecules determined simultaneously using the Human Cytokine Array Kit da R&D Systems (C5a, IL-4, IL-32 alpha, CD40 ligand, IL-5, CXCL10 / IP-10, G-CSF, IL-6, CXCL11 / I-TAC, GM-CSF, IL-8, CCL2 / MCP-1, CXCL1 / GRO alpha, IL-10, MIF, CCL1 / I-309, IL-12 p70, CCL3 / MIP-1 alpha, ICAM-1, IL-13, CCL4 / MIP-1 beta, IFN -gamma, IL-16, CCL5 / RANTES, IL-1 alpha, IL-17, CXCL12 / SDF-1, IL-1 beta, IL-17E, Serpin E1 / PAI-1, IL-1ra, IL-23, TNF-alpha, IL-2, IL-27 and TREM-1)
Presence of antibodies against SARS-CoV-2 in serum after convalescent plasma administration
Death rate
Rate of transfusion reactions to convalescent plasma infusion
Full Information
NCT ID
NCT04528368
First Posted
August 19, 2020
Last Updated
August 4, 2021
Sponsor
D'Or Institute for Research and Education
Collaborators
Hospital do Coracao
1. Study Identification
Unique Protocol Identification Number
NCT04528368
Brief Title
Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
Official Title
Efficacy and Safety of Using Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
January 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
D'Or Institute for Research and Education
Collaborators
Hospital do Coracao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The COVID-19 pandemic has been spreading continuously, and in Brazil, until August 18, 2020, there have been more than 3,359,000 cases with more than 108,536 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of using convalescent plasma for treating patients with COVID-19 pneumonia without indication of ventilatory support.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Convalescent plasma, SARS-CoV-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Convalescent Plasma + Standard treatment
Arm Type
Experimental
Arm Description
Participants will receive the standard treatment and convalescent plasma
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
Participants will receive the standard treatment
Intervention Type
Biological
Intervention Name(s)
Convalescent plasma
Intervention Description
The intervention group will receive 400 mL of convalescent plasma with a SARS-CoV-2 antispike antibody titer with a dilution ≥ 1: 320.
Primary Outcome Measure Information:
Title
Area under the curve of SARS-COV-2 viral load obtained from nasopharyngeal and /or oropharyngeal swabs.
Description
To evaluate the area under the curve of SARSCoV-2 viral load in nasopharyngeal and or oropharyngeal samples on days 0, 3, 6, 9, 12, 15, 18 and 15 after randomization.
Time Frame
0, 3, 6, 9, 12, 15, 18 and 21 days
Secondary Outcome Measure Information:
Title
Assessment of clinical improvement using an Ordinal Severity Scale
Description
The seven-point scale is as follows:
Death 7 points;
Hospital admission for mechanical ventilation plus additional organ support (eg, pressors, RRT, ECMO) = 6 points;
Hospital admission for mechanical ventilation = 5 points;
Hospital admission for non-invasive ventilation or high-flow oxygen therapy = 4 points;
Hospital admission for oxygen therapy (but not requiring high-flow or non-invasive ventilation) = 3 points;
Hospital admission but not requiring oxygen therapy = 2 points;
Discharged with limitations of activities = 1 point;
Discharged with no limitations of activities = 0 point;
Time Frame
0, 7, 10, 14, 21 and 28 days
Title
Evaluate oxygen saturation
Time Frame
0, 3, 6, 9, 12, 15, 18 and 21 days
Title
Evaluate oxygen supplementation
Time Frame
0, 3, 6, 9, 12, 15, 18 and 21 days
Title
Assess respiratory rate
Time Frame
0, 3, 6, 9, 12, 15, 18 and 21 days
Title
Evaluate the PaO2 / FiO2 ratio (for patients on mechanical mechanisms)
Time Frame
0, 3, 6, 9, 12, 15, 18 and 21 days
Title
Length of hospital stay
Time Frame
21 days
Title
Length of stay in intensive care
Time Frame
21 days
Title
Assess the rate of orotracheal intubation
Time Frame
21 days
Title
Change in the profile of cytokines/chemokines in both groups
Description
Quantification by ELISA the levels of 36 molecules determined simultaneously using the Human Cytokine Array Kit da R&D Systems (C5a, IL-4, IL-32 alpha, CD40 ligand, IL-5, CXCL10 / IP-10, G-CSF, IL-6, CXCL11 / I-TAC, GM-CSF, IL-8, CCL2 / MCP-1, CXCL1 / GRO alpha, IL-10, MIF, CCL1 / I-309, IL-12 p70, CCL3 / MIP-1 alpha, ICAM-1, IL-13, CCL4 / MIP-1 beta, IFN -gamma, IL-16, CCL5 / RANTES, IL-1 alpha, IL-17, CXCL12 / SDF-1, IL-1 beta, IL-17E, Serpin E1 / PAI-1, IL-1ra, IL-23, TNF-alpha, IL-2, IL-27 and TREM-1)
Time Frame
0, 3, 6, 9, 12, 15, 18 and 21 days
Title
Presence of antibodies against SARS-CoV-2 in serum after convalescent plasma administration
Time Frame
0, 3, 6, 9, 12, 15, 18 and 21 days
Title
Death rate
Time Frame
7, 10, 14, 21 and 28 days
Title
Rate of transfusion reactions to convalescent plasma infusion
Time Frame
21 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Recipient Inclusion Criteria:
Confirmed diagnosis of COVID-19 by RT-PCR;
Time between symptom onset and inclusion ≤ 7 days;
Chest tomography with <50% involvement of the lung parenchyma;
No indication of ventilatory support at the time of randomization;
Sign the consent form.
Recipient Exclusion Criteria:
Contraindication to transfusion or history of previous reactions to blood products for transfusion;
Pregnant women;
Limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator.
Donor Inclusion Criteria for Plasmapheresis:
Convalescent plasma donation will be eligible for patients ≥ 18 years old who had previously confirmed COVID-19 by RT-PCR, which met the criteria adopted by technical notes n13 and 21/2020-CGSH/DAET/SAES/MS;
SARS-COV-2 negative RT-PCR;
Asymptomatic for at least 14 days;
SARS-CoV-2 anti-peak titre with dilution ≥ 1: 320;
Sign the consent form.
Donor Exclusion Criteria:
Female gender with previous pregnancy;
Absence of peripheral venous network compatible with the apheresis procedure;
Positive or indeterminate result in any of the infectious screening tests;
Presence of intellectual incapacity to understand the guidelines regarding the risks and benefits of participating in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo M Rego, MD, PhD
Phone
55 16 981110090
Email
edumrego@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abel Costa Neto, MD
Phone
55 11 964999091
Email
abel.neto@oncologiador.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo M Rego, MD, PhD
Organizational Affiliation
D'Or Institute for Research and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
D'Or Institute for Research and Education
City
Rio de Janeiro
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo M Rego, MD, PhD
First Name & Middle Initial & Last Name & Degree
Eduardo M Rego, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
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