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류마티스 환자(COVER-CoAd)에서 COVID-19 VaccinE 반응 및 병용투여

2026년 9월 21일 업데이트: Kevin Winthrop, Oregon Health and Science University

류마티스 환자(COVER-CoAd)에서 COvid19 VaccinE 반응 및 병용투여

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.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

129

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
생물학적: Hepatitis A vaccine

Vaccination series administered to prevent hepA infection.

다른 이름들:
  • 하브릭스
생물학적: Diphtheria, pertussis, and tetanus booster vaccine

Vaccination booster administered to prevent diphtheria, pertussis, and tetanus

다른 이름들:
  • 부스트릭스
활성 비교기: 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.
생물학적: Hepatitis A vaccine

Vaccination series administered to prevent hepA infection.

다른 이름들:
  • 하브릭스
활성 비교기: 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.
생물학적: Diphtheria, pertussis, and tetanus booster vaccine

Vaccination booster administered to prevent diphtheria, pertussis, and tetanus

다른 이름들:
  • 부스트릭스
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 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.
기간: 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.
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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.
기간: 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.
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Oregon Health and Science University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 10월 11일

기본 완료 (실제)

2025년 4월 1일

연구 완료 (실제)

2026년 8월 14일

연구 등록 날짜

최초 제출

2022년 9월 2일

QC 기준을 충족하는 최초 제출

2022년 9월 14일

처음 게시됨 (실제)

2022년 9월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 21일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • COVER-CoAd

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다