Clinical Impact of COVID-19 by P.1 SARS-CoV-2 Lineage
Clinical Impact of Coronavirus Disease 19 (COVID-19) Caused by P.1 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Lineage
Since the first report of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concern (VOC) P.1 in Manaus, Brazil, a rapid spread of this lineage across the country has been observed. Recent studies indicate that this variant is associated with higher transmissibility; it is not known whether it is associated with clinical severity and higher mortality rates.
This is a retrospective cohort study carried out at Hospital de Clínicas de Porto Alegre. Adult patients aged 18 years or more and 65 years or less who were admitted to the hospital due to symptomatic COVID-19 from June 2020 to May 2021 and had a reverse transcriptase-polymerase chain reaction (RT-PCR) cycle threshold value for either SARS-CoV-2 N1 or N2 target ≤ 25 were eligible to the study. Samples from 86 patients (43 from June 2020 to November 2020 and 43 from February 2021 to May 2021) were sequenced for further evaluation. These dates were defined since the emergence of P.1 lineage in late January.
Clinical data regarding ventilatory support, date of onset of symptoms, laboratory findings and mortality were collected from each patient. This retrospective cohort aims to assess whether the number of days needed for supplementary oxygen either by noninvasive ventilation or high-flow nasal cannula from onset of symptoms differs among patients infected with the P.1 SARS-CoV-2 variant and those infected with other variants.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
RS
-
Porto Alegre、RS、ブラジル、90035-903
- Hospital de Clinicas de Porto Alegre
-
-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients aged 18 to 65 years
- Hospital admission due to symptomatic COVID-19
- RT-PCR was collected from June to November 2020 or from February to May 2021
Exclusion Criteria:
- Patients admitted for reasons other than COVID-19
- Asymptomatic patients with positive routine screening with RT-PCR
- Patients transferred from other institutions
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
P.1
Patients infected with the P.1 SARS-CoV-2 variant
|
Collection of clinical and laboratory data
|
|
Other variants
Patients infected with SARS-CoV-2 variants other than P.1
|
Collection of clinical and laboratory data
|
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 |
|---|---|---|
|
Time to Advanced Respiratory Support
時間枠：28 days from onset of symptoms
|
Number of days needed for supplementary oxygen either by noninvasive ventilation or high-flow nasal cannula from onset of symptoms.
|
28 days from onset of symptoms
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of patients in each category in the ordinal scale during hospitalization
時間枠：28 days from hospital admission
|
Proportion of patients in each category in the ordinal scale during hospitalization.
Ordinal scale levels: 1, patient not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation or extracorporeal membrane oxygenation; and 6, death.
|
28 days from hospital admission
|
|
Arterial oxygen partial pressure (PaO2)/ Fractional inspired oxygen (FiO2) evolution during hospitalization
時間枠：28 day from hospital admission
|
Proportion of patients in each category according to PaO2/FiO2 value: 400-301, 300-201, 200-101, <=100.
|
28 day from hospital admission
|
|
28-day Mortality from onset of symptoms
時間枠：28 days from onset of symptoms
|
Death for any cause from onset of symptoms
|
28 days from onset of symptoms
|
|
Time to death from onset of symptoms
時間枠：28 days from onset of symptoms
|
Number of days from the onset of symptoms to death
|
28 days from onset of symptoms
|
|
28-day Mortality from hospital admission
時間枠：28 days from hospital admission
|
Death for any cause from hospital admission
|
28 days from hospital admission
|
|
Time to death from hospital admission
時間枠：28 days from hospital admission
|
Number of days from the hospital admission to death
|
28 days from hospital admission
|
|
Days alive and free of supplemental oxygen support.
時間枠：28 day from hospital admission
|
Number of days alive and free of supplemental oxygen support
|
28 day from hospital admission
|
|
Time to invasive ventilatory support
時間枠：28 days from onset of symptoms
|
Number of days from the onset of symptoms to mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)
|
28 days from onset of symptoms
|
|
Need of critical care
時間枠：28 days from hospital admission
|
Proportion of patients admitted to Intensive Care Unit
|
28 days from hospital admission
|
|
In-hospital mortality
時間枠：90 days from hospital admission
|
Death for any cause during hospitalization
|
90 days from hospital admission
|
|
Number of thromboembolic event
時間枠：28 day from hospital admission
|
Number of patients with documented deep venous thrombosis or pulmonary embolism
|
28 day from hospital admission
|
|
Number of patients requiring renal replacement therapy (RRT)
時間枠：28 day from hospital admission
|
Number of patients requiring any form of RRT during hospitalization
|
28 day from hospital admission
|
|
Number of patients requiring prone positioning
時間枠：28 day from hospital admission
|
Number of patients requiring prone positioning during hospitalization
|
28 day from hospital admission
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- 2020-0163
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?
試験データ・資料
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。