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A resposta e coadministração da vacina COVID-19 em pacientes reumatológicos (COVER-CoAd)

21 de setembro de 2026 atualizado por: Kevin Winthrop, Oregon Health and Science University

A resposta e coadministração da vacina COvid19 em pacientes reumatológicos (COVER-CoAd)

Based on the experience with influenza, pneumococcal, and shingles vaccinations in rheumatic disease populations, it is clear that some disease modifying anti-rheumatic drugs and the immunomodulatory therapies used to treat immune-mediated inflammatory diseases have the capacity to blunt immune responses to COVID-19 vaccines.

Several studies have suggested that patients with autoimmune conditions may be at increased risk of poor COVID-19 outcomes. There is an urgent need to better clarify the immunogenicity and safety of COVID-19 vaccines in people living with rheumatic disease who use immunomodulatory therapies. Boosters at annual or other frequency are available, and there is a need to understand whether these vaccines can be given concurrently with other routine vaccines.

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Descrição detalhada

The COVID-19 pandemic, caused by the coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), has infected a substantial portion of the world population, leading to millions of deaths since its first description in December of 2019. Recently, several SARS-CoV-2 vaccines have shown excellent efficacy and tolerability in the general population and have been either fully approved or given emergency use authorization by the US Food and Drug Administration (FDA), while several other vaccines are in late-stage clinical trials.

Patients with autoimmune conditions, however, particularly those receiving immunomodulatory therapies, have largely been excluded from clinical trials. Yet, certain immunomodulatory therapies have been shown to affect responses to vaccines, with effects varying depending on the medication and type of vaccine. In line with the experience with influenza, pneumococcal and shingles vaccinations in rheumatic disease populations, it is clear that some disease modifying anti-rheumatic drugs (DMARDs) and the immunomodulatory therapies used to treat immune-mediated inflammatory diseases have the capacity to blunt immune responses to COVID-19 vaccines. In addition, a hypothetical concern is that stimulation of the immune system could lead to flares of autoimmune conditions, or new onset autoimmune manifestations. Concerns about flare or disease worsening with vaccination is also substantial among patients themselves, and can sometimes be a reason for vaccine hesitancy or refusal.

Due to recent development and subsequent massive deployment of SARS-CoV-2 vaccines to combat the pandemic, their safety and immunogenicity in patients receiving immunomodulatory therapies had received limited evaluation to date. At the same time, several studies have suggested that patients with autoimmune conditions may be at increased risk of poor COVID-19 outcomes, including hospitalization and death, raising the importance of effective vaccination in this setting. In this context, there is an urgent need to better clarify the immunogenicity and safety of COVID-19 vaccines in people living with rheumatic disease who use immunomodulatory therapies. Additionally, the likelihood that patients will need to be vaccinated in the future again for COVID-19 is high. Boosters at annual or other frequency are likely for all (and have now already been recommended for immunocompromised individuals), and the need to understand whether these vaccines can be given concurrently with other routine vaccines will be important for both patients and clinicians, as well as public health officials. The "vaccine moment" clinically frequently offers the opportunity to give multiple vaccines at one time. Vaccines for other respiratory pathogens (e.g. influenza), hepatitis A, pertussis, and other disease are indicated in large segments of the population, including being of utmost importance in the elderly and those with various chronic conditions and/or immunosuppression. It is imperative to understand whether co-administrated vaccines affect the immunogenicity, efficacy, or safety of COVID-19 vaccines and those vaccines of public health significance given concurrently.

With this background in mind and the momentum of the vaccine campaign in the US to date, whereby the majority of at-risk rheumatology and other populations have received their initial vaccine series, this protocol will focus on evaluating vaccine responses in those receiving a booster mRNA SARS-CoV-2 vaccination. This is important, as boosters are now recommended for all adult patients in the US who have received any prior SARS-CoV-2 vaccination. Further, given a large percentage of rheumatology patients can have sub-optimal or lower immune responses, booster vaccinations will be likely of utmost importance to these and other immunosuppressed groups.

Tipo de estudo

Intervencional

Inscrição (Real)

129

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Alabama
      • Northport, Alabama, Estados Unidos, 35473
        • Center for Rheumatic Diseases
    • Florida
      • Riverview, Florida, Estados Unidos, 33569
        • Southwest Florida Rheumatology
    • Idaho
      • Boise, Idaho, Estados Unidos, 83702
        • St. Luke's Rheumatology
    • New Mexico
      • Clovis, New Mexico, Estados Unidos, 88101
        • Jayashree Sinha, MD
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Duncansville, Pennsylvania, Estados Unidos, 16635
        • Altoona Center for Clinical Research
    • Tennessee
      • Crossville, Tennessee, Estados Unidos, 38555
        • Cumberland Rheumatology

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Patients must meet all of the inclusion criteria at the time of screening
  • Must be 18 years of age or older
  • Must live in the United States
  • Scheduled for SARS-CoV-2 booster vaccination
  • Patients in Rheumatic Disease arm (arm 4) must have inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis, other) and be receiving stable doses of one of the following medication classes: TNF antagonists, B-cell depletion agents, IL-6 inhibitors, JAK inhibitors, IL-12/23 or IL-23 blockers, IL-17 inhibitors, methotrexate, sulfasalazine, leflunamide, or chronic prednisone (>15mg/day). Stable dosing is defined as no change in dose in the 30 days prior to enrolment.
  • For Arms 1-3: patients seen by rheumatologists who do not have active rheumatic disease requiring immunosuppressive therapy. These will include patients with a past history of auto-immune disease that is no longer active, as well as those with other chronic conditions not associated with autoimmune condition such as osteoarthritis, osteoporosis, or other.
  • Patients in the Co-administration arms (arms 2 and 3) must meet ACIP recommendations for the use of HAVRIX® (i.e. not previously vaccinated) and BOOSTRIX® (i.e. last immunization >9 years ago).
  • Patients who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the REDCap/diary cards, capable of receiving text messages and/or have a personal email address, return for follow-up visits).

Exclusion Criteria:

  • Active infection with SARS-CoV-2 (symptom onset or first positive test in the 14 days prior to recruitment) / disease
  • Any known contraindication to SARS-CoV-2 (booster) vaccination, including severe allergy to vaccine components
  • Prior use of adenoviral COVID-19 vaccination
  • Known or history of HIV/AIDS
  • Currently receiving radiation or chemotherapy for any type of malignancy
  • Receipt of any immunizations other than SARS-CoV-2 within two weeks prior planned SARS-CoV-2 vaccination, or scheduled within 10 weeks after visit 1
  • Significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to < 1 year)
  • Patients who have a previous history of pericarditis/myocarditis associated with vaccination
  • Any other reason that, in the opinion of the site investigator, would interfere with required study related evaluations (e.g. uncontrolled comorbidity)
  • Prior receipt of any hepatitis A containing vaccine
  • Prior receipt of diphtheria, acellular pertussis, or tetanus vaccination within the last 9 years
  • History of physician-diagnosed or laboratory confirmed pertussis within the past 5 years; any history of diphtheria, tetanus disease, or hepatitis A.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Arm 1 (control group, sequential administration)

Individuals with other chronic conditions and not active rheumatic disease (defined as being treated), who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination.

This arm will receive sequential administration of both tdap booster and hepA vaccinations.
Biológico: Hepatitis A vaccine

Vaccination series administered to prevent hepA infection.

Outros nomes:
  • Havrix
Biológico: Diphtheria, pertussis, and tetanus booster vaccine

Vaccination booster administered to prevent diphtheria, pertussis, and tetanus

Outros nomes:
  • Boostrix
Comparador Ativo: Arm 2 (co-administration group)

Individuals with other chronic conditions and not active rheumatic disease (defined as being treated), who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination.

This arm will receive co-administration of hepA vaccination.
Biológico: Hepatitis A vaccine

Vaccination series administered to prevent hepA infection.

Outros nomes:
  • Havrix
Comparador Ativo: Arm 3 (co-administration group)

Individuals with other chronic conditions and not active rheumatic disease (defined as being treated), who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination.

This arm will receive co-administration of tdap booster vaccination.
Biológico: Diphtheria, pertussis, and tetanus booster vaccine

Vaccination booster administered to prevent diphtheria, pertussis, and tetanus

Outros nomes:
  • Boostrix
Sem intervenção: Arm 4 (Inflammatory arthritis patients using DMARDS)

Individuals with inflammatory arthritis patients using DMARDS, who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination.

This arm will only receive the standard of care COVID-19 booster vaccination.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 measured post-vaccination for those who received only the SARS-CoV-2 booster compared to those who received sequential vaccination with the SARS-CoV-2 booster.
Prazo: 2 years

Descriptively evaluate the immunogenicity of anti-spike IgG among patients receiving SARS-CoV-2 booster vaccines alone (Arm 4 N=100) as compared to patients receiving SARS-CoV-2 booster vaccine with sequential vaccination (Arm 1 N=100). The geometric mean concentration ratio (GMC) of Arm 4 to Arm 1 at Week 4 will be reported.
2 years
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received sequential vaccination with the SARS-CoV-2 booster compared to those who received a tdap booster co-administered with the SARS-CoV-2 booster.
Prazo: 2 years

Descriptively evaluate the immunogenicity of anti-spike IgG among patients receiving SARS-CoV-2 booster vaccines with sequential vaccination (Arm 1 N=100) as compared to patient receiving SARS-CoV-2 booster vaccine with co-administration of BOOSTRIX® (Arm 2 N=100). The geometric mean concentration ratio (GMC) of Arm 1 to Arm 2 at each 4-week interval for Arm 1 (e.g. Week 4, 8, and 36) will be reported.
2 years
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received sequential vaccination with the SARS-CoV-2 booster compared to those who received a hepA vaccination co-administered with the SARS-CoV-2 booster.
Prazo: 2 years

Descriptively evaluate the immunogenicity of anti-spike IgG among patients receiving SARS-CoV-2 booster vaccines with sequential vaccination (Arm 1 N=100) as compared to patient receiving SARS-CoV-2 booster vaccine with co-administration of HAVRIX® (Arm 3 N=100). The geometric mean concentration ratio (GMC) of Arm 1 to Arm 3 at each 4-week interval for Arm 1 (e.g. Week 4, 8, and 36) will be reported.
2 years
Number of participants with solicited localized and general symptoms (Arm 4 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines alone (Arm 4 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine with sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of participants with solicited local and general symptoms that occur within an 8 day period following each vaccine dose administered as assessed by CTCAE will be reported.
2 years
Number of participants with unsolicited events (Arm 4 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines alone (Arm 4 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine with sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of participants with unsolicited events occurring within a 31 day period following each vaccine dose administered as assessed by CTCAE will be reported.
2 years
Number of medically attended events (Arm 4 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) or co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). All medically attended events.
2 years
Number of confirmed cases of COVID-19 (Arm 4 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) or co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of confirmed cases of COVID-19 as diagnosed by PCR or antigen-based testing.
2 years
Number of potential immune-mediated diseases (Arm 4 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) or co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of potential immune-mediated diseases (pIMDs; new onset or exacerbation of current).
2 years
Number of serious adverse events (Arm 4 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) or co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of serious adverse events as assessed by CTCAE.
2 years
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received a tdap booster co-administered with the SARS-CoV-2 booster compared to those who received sequential vaccination with the SARS-CoV-2 booster.
Prazo: 2 years

Descriptively evaluate the immunogenicity of anti-spike IgG among patients receiving SARS-CoV-2 booster vaccine with co-administration of BOOSTRIX® (Arm 2 N=100) as compared to patients receiving SARS-CoV-2 booster vaccine with sequential vaccination (Arm 1 N=100). The geometric mean concentration ratio (GMC) of Arm 2 to Arm 1 at 4 weeks post-vaccination for SARS CoV-2 and BOOSTRIX®.
2 years
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received a hepA vaccination co-administered with the SARS-CoV-2 booster compared to those who received sequential vaccination with the SARS-CoV-2 booster.
Prazo: 2 years

Descriptively evaluate the immunogenicity of anti-spike IgG among patients receiving SARS-CoV-2 booster vaccine with co-administration of HAVRIX® (Arm 3 N=100) as compared to patients receiving SARS-CoV-2 booster vaccine with sequential vaccination (Arm 1 N=100). The geometric mean concentration ratio (GMC) of Arm 3 to Arm 1 at 4 weeks post-vaccination for dose 2 of HAVRIX® will be reported.
2 years
Number of participants with solicited localized and general symptoms (Arm 2 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of participants with solicited local and general symptoms that occur within an 8 day period following each vaccine dose administered as assessed by CTCAE.
2 years
Number of participants with unsolicited events (Arm 2 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of participants with unsolicited events occurring within a 31 day period following each vaccine dose administered as assessed by CTCAE.
2 years
Number of medically attended events (Arm 2 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). All medically attended events.
2 years
Number of confirmed cases of COVID-19 (Arm 2 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of confirmed cases of COVID-19 as diagnosed by PCR or antigen-based testing.
2 years
Number of potential immune-mediated diseases (Arm 2 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of potential immune-mediated diseases (pIMDs; new onset or exacerbation of current).
2 years
Number of serious adverse events (Arm 2 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of BOOSTRIX® (Arm 2 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of serious adverse events.
2 years
Number of participants with solicited localized and general symptoms (Arm 3 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of participants with solicited local and general symptoms that occur within an 8 day period following each vaccine dose administered as assessed by CTCAE.
2 years
Number of participants with unsolicited events (Arm 3 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of participants with unsolicited events occurring within a 31 day period following each vaccine dose administered as assessed by CTCAE
2 years
Number of medically attended events (Arm 3 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). All medically attended events
2 years
Number of confirmed cases of COVID-19 (Arm 3 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of confirmed cases of COVID-19 as diagnosed by PCR or antigen-based testing
2 years
Number of potential immune-mediated diseases (Arm 3 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of potential immune-mediated diseases (pIMDs; new onset or exacerbation of current).
2 years
Number of serious adverse events (Arm 3 to Arm 1)
Prazo: 2 years

Descriptively evaluate the safety and reactogenicity of patients receiving SARS-CoV-2 booster vaccines with either co-administration of HAVRIX® (Arm 3 N=100; cell-mediated immunity subset N=50 of first enrolled) as compared to patients receiving SARS-CoV-2 booster vaccine sequential vaccination (Arm 1 N=100; cell-mediated immunity subset N=50 of first enrolled). Number of serious adverse events as assessed by CTCAE.
2 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Oregon Health and Science University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

11 de outubro de 2022

Conclusão Primária (Real)

1 de abril de 2025

Conclusão do estudo (Real)

14 de agosto de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

2 de setembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de setembro de 2022

Primeira postagem (Real)

16 de setembro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • COVER-CoAd

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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