NCT04528368

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_2 covid19

Timeline
Completed

Started Dec 2020

Typical duration for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

December 11, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

August 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

August 19, 2020

Last Update Submit

August 4, 2021

Conditions

COVID-19

Keywords

Convalescent plasmaSARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • 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.

    0, 3, 6, 9, 12, 15, 18 and 21 days

Secondary Outcomes (12)

  • Assessment of clinical improvement using an Ordinal Severity Scale

    0, 7, 10, 14, 21 and 28 days

  • Evaluate oxygen saturation

    0, 3, 6, 9, 12, 15, 18 and 21 days

  • Evaluate oxygen supplementation

    0, 3, 6, 9, 12, 15, 18 and 21 days

  • Assess respiratory rate

    0, 3, 6, 9, 12, 15, 18 and 21 days

  • Evaluate the PaO2 / FiO2 ratio (for patients on mechanical mechanisms)

    0, 3, 6, 9, 12, 15, 18 and 21 days

  • +7 more secondary outcomes

Study Arms (2)

Convalescent Plasma + Standard treatment

EXPERIMENTAL

Participants will receive the standard treatment and convalescent plasma

Biological: Convalescent plasma

Standard treatment

NO INTERVENTION

Participants will receive the standard treatment

Interventions

Convalescent plasmaBIOLOGICAL

The intervention group will receive 400 mL of convalescent plasma with a SARS-CoV-2 antispike antibody titer with a dilution ≥ 1: 320.

Convalescent Plasma + Standard treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of COVID-19 by RT-PCR;
  • Chest tomography with \<50% involvement of the lung parenchyma;
  • No indication of ventilatory support at the time of randomization;
  • Sign the consent form.

You may not qualify if:

  • 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.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

D'Or Institute for Research and Education

Rio de Janeiro, Brazil

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Eduardo M Rego, MD, PhD

    D'Or Institute for Research and Education

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo M Rego, MD, PhD

CONTACT

55 16 981110090edumrego@hotmail.com

Abel Costa Neto, MD

CONTACT

55 11 964999091abel.neto@oncologiador.com.br

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 27, 2020

Study Start

December 11, 2020

Primary Completion

December 30, 2021

Study Completion

January 30, 2022

Last Updated

August 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)