Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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

Tracking Information
First Submitted Date  ICMJE August 19, 2020
First Posted Date  ICMJE August 27, 2020
Last Update Posted Date August 6, 2021
Actual Study Start Date  ICMJE December 11, 2020
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
  • 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;
  • Evaluate oxygen saturation [ Time Frame: 0, 3, 6, 9, 12, 15, 18 and 21 days ]
  • Evaluate oxygen supplementation [ Time Frame: 0, 3, 6, 9, 12, 15, 18 and 21 days ]
  • Assess respiratory rate [ Time Frame: 0, 3, 6, 9, 12, 15, 18 and 21 days ]
  • Evaluate the PaO2 / FiO2 ratio (for patients on mechanical mechanisms) [ Time Frame: 0, 3, 6, 9, 12, 15, 18 and 21 days ]
  • Length of hospital stay [ Time Frame: 21 days ]
  • Length of stay in intensive care [ Time Frame: 21 days ]
  • Assess the rate of orotracheal intubation [ Time Frame: 21 days ]
  • 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)
  • 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 ]
  • Death rate [ Time Frame: 7, 10, 14, 21 and 28 days ]
  • Rate of transfusion reactions to convalescent plasma infusion [ Time Frame: 21 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
Official Title  ICMJE Efficacy and Safety of Using Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Convalescent Plasma + Standard treatment
    Participants will receive the standard treatment and convalescent plasma
    Intervention: Biological: Convalescent plasma
  • No Intervention: Standard treatment
    Participants will receive the standard treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 25, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04528368
Other Study ID Numbers  ICMJE 34651120.8.0000.5249
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party D'Or Institute for Research and Education
Study Sponsor  ICMJE D'Or Institute for Research and Education
Collaborators  ICMJE Hospital do Coracao
Investigators  ICMJE
Principal Investigator: Eduardo M Rego, MD, PhD D'Or Institute for Research and Education
PRS Account D'Or Institute for Research and Education
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP