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Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support

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ClinicalTrials.gov Identifier: NCT04528368
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : August 6, 2021
Sponsor:
Collaborator:
Hospital do Coracao
Information provided by (Responsible Party):
D'Or Institute for Research and Education

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Using Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
Actual Study Start Date : December 11, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Convalescent Plasma + Standard treatment
Participants will receive the standard treatment and convalescent plasma
Biological: Convalescent plasma
The intervention group will receive 400 mL of convalescent plasma with a SARS-CoV-2 antispike antibody titer with a dilution ≥ 1: 320.

No Intervention: Standard treatment
Participants will receive the standard treatment



Primary Outcome Measures :
  1. Area under the curve of SARS-COV-2 viral load obtained from nasopharyngeal and /or oropharyngeal swabs. [ Time Frame: 0, 3, 6, 9, 12, 15, 18 and 21 days ]
    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 :
  1. Assessment of clinical improvement using an Ordinal Severity Scale [ Time Frame: 0, 7, 10, 14, 21 and 28 days ]

    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;

  2. Evaluate oxygen saturation [ Time Frame: 0, 3, 6, 9, 12, 15, 18 and 21 days ]
  3. Evaluate oxygen supplementation [ Time Frame: 0, 3, 6, 9, 12, 15, 18 and 21 days ]
  4. Assess respiratory rate [ Time Frame: 0, 3, 6, 9, 12, 15, 18 and 21 days ]
  5. Evaluate the PaO2 / FiO2 ratio (for patients on mechanical mechanisms) [ Time Frame: 0, 3, 6, 9, 12, 15, 18 and 21 days ]
  6. Length of hospital stay [ Time Frame: 21 days ]
  7. Length of stay in intensive care [ Time Frame: 21 days ]
  8. Assess the rate of orotracheal intubation [ Time Frame: 21 days ]
  9. Change in the profile of cytokines/chemokines in both groups [ Time Frame: 0, 3, 6, 9, 12, 15, 18 and 21 days ]
    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)

  10. 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 ]
  11. Death rate [ Time Frame: 7, 10, 14, 21 and 28 days ]
  12. Rate of transfusion reactions to convalescent plasma infusion [ Time Frame: 21 days ]


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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT04528368


Contacts
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Contact: Eduardo M Rego, MD, PhD 55 16 981110090 edumrego@hotmail.com
Contact: Abel Costa Neto, MD 55 11 964999091 abel.neto@oncologiador.com.br

Locations
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Brazil
D'Or Institute for Research and Education Recruiting
Rio de Janeiro, Brazil
Contact: Eduardo M Rego, MD, PhD         
Principal Investigator: Eduardo M Rego, MD, PhD         
Sponsors and Collaborators
D'Or Institute for Research and Education
Hospital do Coracao
Investigators
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Principal Investigator: Eduardo M Rego, MD, PhD D'Or Institute for Research and Education
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Responsible Party: D'Or Institute for Research and Education
ClinicalTrials.gov Identifier: NCT04528368    
Other Study ID Numbers: 34651120.8.0000.5249
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: January 2021
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by D'Or Institute for Research and Education:
Convalescent plasma
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases