Late Clinical Events Associated With COVID-19 Infection (COCO-LATE)
Late Clinical Events Associated With COVID-19 Infection: Multicenter Cohort
Several publications document the occurrence of symptoms that persist or occur late.
The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients.
Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed.
調査の概要
詳細な説明
Several publications document the occurrence of symptoms that persist or occur late, more than 3 weeks after the first clinical manifestations of an SARS-COV2 infection. These manifestations may be related to thromboembolic or inflammatory complications, superinfections, or other mechanisms not yet well understood, including potentially related to the persistence of SARS-COV2. The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients.
Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed. In parallel, the prevalence of the main symptoms observed more than 3 weeks after the onset of a COVID-19 will be estimated through partnerships with existing cohort studies in the general population or in the population followed for COVID-19, still symptomatic or not at 3 weeks of infection.
Longitudinal implementation of bio-libraries will allow this cohort to also constitute a bridge between clinicians and researchers.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Olivier ROBINEAU, MD PhD
- 電話番号：0320694949
- メール：orobineau@ch-tourcoing.fr
研究場所
-
-
-
Auxerre、フランス
- 募集
- CH Auxerre
-
Caen、フランス
- 募集
- CHU Caen
-
Lille、フランス
- 募集
- CHRU Lille
-
Melun、フランス
- 募集
- CH Melun Marc Jacquet
-
Nemours、フランス
- 募集
- CH Sud Seine et Marne
-
Paris、フランス
- まだ募集していません
- AP-HP Hôpital Hôtel-Dieu
-
Saint-Priest-en-Jarez、フランス
- 募集
- CHU de Saint-Etienne
-
Tourcoing、フランス
- 募集
- CH Tourcoing
-
Tours、フランス
- 募集
- Chru Tours
-
Vandœuvre-lès-Nancy、フランス
- 募集
- CHRU NANCY
-
Vannes、フランス
- 募集
- Centre Hospitalier Bretagne Atlantique
-
-
-
-
-
Cayenne、フランス領ギアナ
- 募集
- CH André Rosemon de Cayenne
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
History of symptomatic CoV-2-SARS infection as defined by :
o Positive RT-PCR SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology
o Associated with at least one event : x Anosmia occurring after February 2020 x OR COVID 19 evocative scanner x OR ≥ 2 contemporary symptoms of the virological sample from: asthenia, cough, dyspnea, fever, myalgia, dysgeusia, diarrhea AND not present prior to diagnosis
- AND persistence of at least one symptom present in the first 3 weeks of a COVID-19, more than 8 weeks away from the first symptoms of COVID-19. OR late onset of at least one new symptom a minimum of 3 weeks and a maximum of 6 months after the first symptoms of a CoV-2 SARS infection.
- First symptoms less than 6 months old on the day of inclusion
- To benefit from a State Health Insurance or Medical Aid plan
- Have signed an informed consent for inclusion.
Exclusion Criteria:
- Minor patient
- Patient under protection of justice
Patient who required intensive care management :
- more than 5 days
- OR requiring orotracheal intubation
- OR having required high flow ventilation (optiflow)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Standardized clinical and paraclinical follow-up
Standardized clinical and paraclinical follow-up will be offered in one of the referring investigator centers. Patients will be able to benefit from additional biological samples. Questionnaires will be completed by the patient or with the help of clinical research staff in paper format. All patients will make an inclusion visit (IV), then a clinical follow-up will be organized for the study at M4, M6, M12 from the day of the onset of the 1st symptoms of COVID. Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits. Total serum, plasma and naso-paaryngeal samples will be collected. |
Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits.
Total serum, plasma samples will be collected
All patients will make an inclusion visit (IV), then a clinical follow-up will be organized for the study at M4, M6, M12 from the day of the onset of the 1st symptoms of COVID.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical description of asthenia
時間枠：At the end od the study, an average of 22 months
|
Describe the frequence of asthenia between its onset and its disappearance.
Assessment at baseline, then 4, 6 and 12 months.
|
At the end od the study, an average of 22 months
|
|
Clinical description of dyspnea
時間枠：At the end od the study, an average of 22 months
|
Frequence of dyspnea between its onset and its disappearance.
Assessment at baseline, then 4, 6 and 12 months.
Assessment at baseline, then 4, 6 and 12 months.
|
At the end od the study, an average of 22 months
|
|
Clinical description of thoracic disorders
時間枠：At the end od the study, an average of 22 months
|
Frequence of thoracic disorders between its onset and its disappearance.
Assessment at baseline, then 4, 6 and 12 months.
Assessment at baseline, then 4, 6 and 12 months.
|
At the end od the study, an average of 22 months
|
|
Clinical description of neurological disorders
時間枠：At the end od the study, an average of 22 months
|
Frequence of neurological disorders between its onset and its disappearance.
Assessment at baseline, then 4, 6 and 12 months.
Assessment at baseline, then 4, 6 and 12 months.
|
At the end od the study, an average of 22 months
|
|
Clinical description of anosmia
時間枠：At the end od the study, an average of 22 months
|
Frequence of anosmia disorders between its onset and its disappearance.
Assessment at baseline, then 4, 6 and 12 months.
Assessment at baseline, then 4, 6 and 12 months.
|
At the end od the study, an average of 22 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Olivier ROBINEAU, MD PhD、CH Tourcoing
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RIPH_2020_09
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。