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COVID-19Phase 2NCT05077930

Convalescent Plasma Therapy for Hospitalized Patients With COVID-19

A Phase 2 study testing Convalescent plasma in people with COVID-19 and Convalescent Plasma, run by Tânia Portella Costa at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Plasma from donors who have recovered from coronavirus disease 2019 (COVID-19) contain antibodies to SARS-CoV-2 and may be a potential therapy for hospitalized patients with COVID-19. The efficacy of high-titer convalescent plasma for COVID-19, however, still unclear. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, Convalescent Plasma, SARS-CoV-2
What is being tested?
Convalescent plasma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteBrazil
Study dates
6 Jan 2022to 7 Apr 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hospitalized patients aged ≥18 years.
  • Confirmed diagnosis of COVID-19 by RT-PCR or antigen test in respiratory samples.
  • Time between symptom onset and inclusion ≤ 7 days.
  • Enrolled within 5 days of hospitalization.
  • Sign the consent form.

Who cannot join

  • Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure.
  • History of previous severe allergic reactions to transfused blood products.
  • Limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator.
  • Not currently enrolled another interventional clinical trial of COVID-19 treatment.
  • Critically ill patient with COVID-19 being treated in intensive care.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Maternidade e Cirurgia Nossa Senhora do Rocio/ SA - Hospital do Rocio

    Campo Largo, Paraná, 83606-177

Other trials in Brazil

About this study

Official title: Validation Protocol for The Clinical Use of Convalescent Plasma for Hospitalized Patients With COVID-19. A Prospective Study at a Hospital in Southern Brazil.

Plasma from donors who have recovered from coronavirus disease 2019 (COVID-19) contain antibodies to SARS-CoV-2 and may be a potential therapy for hospitalized patients with COVID-19. The efficacy of high-titer convalescent plasma for COVID-19, however, still unclear. The present study aims to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with COVID-19.

Read the detailed description

This is an open-label, randomized controlled trial aimed to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with COVID-19. Participants must be adult hospitalized patients with a confirmed diagnosis of COVID-19 and time Between symptom onset and inclusion ≤ 7 days. Two hundred participants will be randomized in a 1:1 ratio to receive either 200-400 mL of high-titer COVID-19 convalescent plasma or standard care. The primary endpoint is the proportion of patients with clinical improvement at day 14 following randomization, defined by an increase of two points in the 7-point ordinal scale based on that recommended by the World Health Organization. Safety will be daily assessed by monitoring the occurrence of adverse effects and reactions to convalescent plasma transfusion. Study visits will occur on Day 1, Day 3, Day 7, and Day 14 or until hospital discharge, whichever comes first.

Being tested
Convalescent plasma, Standard of care
Medical subject headings
COVID-19, Pneumonia, Coronavirus Infections, Respiratory Tract Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Convalescent plasmaBiological

    The intervention group will receive 200 or 400 mL of high-titer COVID-19 convalescent plasma, ABO compatible with the patient, within 24 hours of randomization.

  • Standard of careDrug

    The active comparator group will receive oxygen supplementation, corticoids, antiretrovirals, and/or monoclonal antibodies according to the institutional protocol.

Study groups in NCT05077930
Study groupRoleWhat they receive
Convalescent PlasmaExperimentalThe investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Centro de Hematologia e Hemoterapia do Paraná - Hemepar following national blood donation guidelines and Brazilian Health Regulatory Agency (ANVISA) criteria. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined. Participants will receive the standard of care treatment and a single unit of convalescent plasma (volume=200 mL or 400 mL).
Receives: Biological: Convalescent plasma
Standard of careActive comparatorStandard of care treatment according to the institutional protocol.
Receives: Drug: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical status on a 7-point ordinal scale

    Patients' clinical status over time assessed by a 7-point ordinal scale from World Health Organization (WHO). Lower scores are seen with better clinical outcomes. The scale categories are as follows: (1), not hospitalized with resumption of normal activities; (2), not hospitalized, but unable to resume normal activities; (3), hospitalized, not requiring supplemental oxygen; (4), hospitalized, requiring supplemental oxygen; (5), hospitalized, requiring high-flow oxygen therapy or noninvasive mechanical ventilation; (6), hospitalized, requiring ECMO (extracorporeal membrane oxygenation), IMV (intermittent mandatory ventilation), or both; (7), death.

    Proportion of patients with clinical improvement, defined by an increase of two points in the ordinal scale of seven WHO categories.

    Measured: From randomization to end of study at Day 14

Secondary outcomes (13)

  1. Percentage of participants at each clinical status on a 7-point ordinal scale

    Measure of patients' clinical status using an ordinal scale for clinical improvement created by World Health Organization (WHO) and based on 7-point scale categories. Lower scores in this scale are seen with better clinical outcomes. The scale categories are as follows: (1), not hospitalized with resumption of normal activities; (2), not hospitalized, but unable to resume normal activities; (3), hospitalized, not requiring supplemental oxygen; (4), hospitalized, requiring supplemental oxygen; (5), hospitalized, requiring high-flow oxygen therapy or noninvasive mechanical ventilation; (6), hospitalized, requiring ECMO, IMV, or both; (7), death.

    Measured: Day 1, Day 3, Day 7, and Day 14 after randomization

  2. Oxygen saturation

    Measured: Day 1, Day 3, Day 7, and Day 14 after randomization

  3. Prevalence of oxygen-intake methods

    Percentage of participants using oxygen by mask or nasal prongs, oxygen by non-invasive ventilation or high flow, intubation \& mechanical ventilation and ECMO.

    Measured: Day 1, Day 3, Day 7, and Day 14 after randomization

  4. Respiratory rate

    Measured: Day 1, Day 3, Day 7, and Day 14 after randomization

  5. The PaO2 / FiO2 ratio (for patients on mechanical mechanisms)

    Measured: Day 1, Day 3, Day 7, and Day 14 after randomization

  6. Number and /or extension of affected lung areas on chest computed tomography

    Measured: Day 1, Day 3, Day 7, and Day 14 after randomization

  7. Length of hospital stay

    Measured: Day 1, Day 3, Day 7, and Day 14 after randomization

  8. Length of stay in intensive care

    Measured: Day 1, Day 3, Day 7, and Day 14 after randomization

  9. Time until independence from oxygen therapy in days

    Measured: Day 1, Day 3, Day 7, and Day 14 after randomization

  10. Ventilator free days

    Measured: Day 1, Day 3, Day 7, and Day 14 after randomization

  11. In patients who needed mechanical ventilation, time to initiate mechanical ventilation (calculated in days, from entry into the protocol until orotracheal intubation)

    Measured: Day 1, Day 3, Day 7, and Day 14 after randomization

  12. Rate of transfusion reactions to convalescent plasma infusion

    Measured: Daily, until Day 14 after randomization

  13. Percentage of participants who develop serious adverse events and adverse events considered as definitely or probably associated with plasma transfusion

    Adverse events (worsening anemia, urticaria, skin rash, transfusion-associated circulatory overload, and others) assessed during hospitalization.

    Measured: Daily, until Day 14 after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2021
  2. Study start6 Jan 2022
  3. Primary completion4 Apr 2022
  4. Study completion7 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is an open-label, randomized study design (1: 1), controlled trial, in hospitalized patients with COVID-19.
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05077930
Sponsor's protocol ID
CCP TRIAL
Status last verified
Nov 2023
First submitted
8 Oct 2021
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Piechotta V, Chai KL, Valk SJ, Doree C, Monsef I, Wood EM, Lamikanra A, Kimber C, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Jul 10;7(7):CD013600. doi: 10.1002/14651858.CD013600.pub2.

    PubMed 32648959

  • Costa TP, Aoki M, Ribeiro CM, Socca E, Itinose L, Basso R, Blanes L. Efficacy of convalescent plasma in hospitalized COVID-19 patients: findings from a controlled trial. Braz J Med Biol Res. 2024 Oct 7;57:e13627. doi: 10.1590/1414-431X2024e13627. eCollection 2024.

    PubMed 39383382

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Convalescent plasma in people with COVID-19 and Convalescent Plasma, run by Tânia Portella Costa at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical status on a 7-point ordinal scale (time frame: From randomization to end of study at Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05077930, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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