Effects of Low Molecular Weight Heparin Therapy With Soft-Mist Inhaler for COVID-19 Induced Hypoxemia
Early Effects of Low Molecular Weight Heparin Therapy With Soft-Mist Inhaler for COVID-19 Induced Hypoxemia: A Phase IIb Trial
調査の概要
詳細な説明
Lungs are the major target organ of COVID-19, caused by the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). Multiple drug options have been evaluated for efficacy against worsening symptoms of COVID-19 patients. Low molecular weight heparin, known for its antiviral and anti-inflammatory effect, was determined to be applicable for ARDS-induced Hypoxemia.
In cases of viral diseases that primarily targets the lungs, oral drugs and parenteral applications have shown to be insufficient due to low drug accumulation in the target organ site. An increase in drug dosage in order to achieve the necessary drug concentration leaves the patient with intolerable side effects. An inhalation delivery route of the drug would not only directly target the lungs but would also require less dosage. This is expected to increase patient tolerability and the efficacy of the treatment.
Soft mist inhalers are advantageous above the other inhalation devices, for it reaches a higher retention rate in the lungs. Furthermore, the device to be used in this clinical study provides an "enclosed system" which decreases the risk of environmental contamination, thus is meant to protect healthcare professionals or to minimize associated contamination risks.
This Phase-IIb clinical trial is to include 40 critically ill COVID-19 induced ARDS patients, that will receive Low molecular Weight Heparin via a soft mist inhaler at a dose of 4000 IU per administration, twice a day for 10 days in addition to the standard treatment determined by the Turkish Ministry of Health. A total of 80 patients will be enrolled, in which the drug receiving group will be assigned. The primary outcome of the clinical study is the improvement of ARDS induced hypoxemia on a 5-scale determination method at the end of the 10th day. The study inquires to perceive the early effects of inhaled Low molecular weight heparin on critically ill COVID-19 patients.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
-
-
Fatih
-
Istanbul、Fatih、七面鳥、34093
- Istanbul University Medical Faculty
-
-
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:
- Positive reserve transcriptase polymerase chain reaction (RT-PCR) test of nasopharyngeal swab for COVID- 19, and pneumonia confirmed by a Computed Tomography (CT).
- Negative reserve transcriptase polymerase chain reaction (RT-PCR) test of nasopharyngeal swab for COVID- 19, but radiological and biochemical examinations unambiguously suggest COVID-19, when other possible diagnoses were excluded.
Exclusion Criteria:
- Pregnancy
- History of heparin and associated drug allergies.
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:処理
- 割り当て:非ランダム化
- 介入モデル:並列代入
- 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 |
---|---|
実験的:Inhalation Treatment
Treatment: Inhaled Low molecular weight heparin + Standard COVID-19 treatment, Inhaled Low molecular weight heparin (4000 IU given twice a day for 10 days) |
Application with Soft Mist Inhaler
他の名前:
|
他の:Control Group
Treatment: Standard COVID-19 treatment
|
Control Group
|
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 |
---|---|---|
Change in clinical status on a 5-point clinical scale for hypoxemia
時間枠:Days 1-10
|
|
Days 1-10
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Improvement rate of the breathing status
時間枠:Day 1 and Day 10
|
Change in number of patients that were able to breath in room air will be compared on Day 1 and Day 10 (Comparison between the Treatment Group and Control Group)
|
Day 1 and Day 10
|
Change in peripheral oxygen saturation (Sp02)
時間枠:Days 1-10
|
A change in SpO2 levels in the duration of the study (SpO2 < % 95)
|
Days 1-10
|
Length of stay
時間枠:Days 1-10
|
Number of patients administered to intensive care unit (ICU)
|
Days 1-10
|
Overall survival
時間枠:Days 1-10
|
During or post-study follow up period
|
Days 1-10
|
協力者と研究者
スポンサー
捜査官
- スタディチェア:Ayca Yildiz-Pekoz, PhD、Istanbul University Faculty of Pharmacy
- スタディディレクター:Mustafa Erelel, MD、Istanbul University Faculty of Medicine
出版物と役立つリンク
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- E-66175679-514.03.01-328141
- 46325 (その他の識別子:Istanbul University Medical Faculty)
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?
IPD プランの説明
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。