Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19 (ProPAC-COVID)
Proactive Protection With Azithromycin and Hydroxychloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19
調査の概要
状態
詳細な説明
In the ongoing coronavirus pandemic, COVID-19, that arose in Wuhan China, there is still sparse data in the course, risk of various complications, and in particular how patients who are hospitalized are best treated to ensure high survival and short hospitalization. Despite the rapid spread of the disease globally, there is no solid data yet to recommend any specific treatments, which is why symptomatic, organ supportive therapy including respiratory therapy in acute pulmonary failure is recommended. There has been reported a high incidence of bacterial super-infections in patients with COVID-19. Patients with COVID-19 also have a higher risk of dying because of septic shock. Thus, there is an urgent need for treatment that can improve the patient's chance of the shortest hospitalization possible, and treatment that can lower the risk of secondary infection and death.
This is a randomized, placebo-controlled, double-blinded multi-center trial evaluating the effect of azithromycin and hydroxychloroquine treatment in patients with COVID-19 during hospitalization. The aim of the study is to investigate whether the treatment can shorten hospitalization, reduce the risk of non-invasive ventilation, admittance to Intensive Care Units and death.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
-
Aalborg、デンマーク
- Aalborg Sygehus
-
Copenhagen、デンマーク
- Bispebjerg Hospital
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Copenhagen、デンマーク
- Hvidovre Hospital
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Copenhagen、デンマーク
- Herlev-Gentofte Hospital
-
Hillerød、デンマーク
- Nordsjællands Hospital
-
Odense、デンマーク
- Odense Universitetshospital
-
Roskilde、デンマーク
- Roskilde Sygehus
-
Slagelse、デンマーク
- Slagelse Sygehus
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Patient admitted to a Danish emergency department, lung medical department or medical department
- Age >18 years
- Hospitalized <48 hours
- Positive COVID-19 test/diagnosis during the hospitalization
- Signs informed consent
Exclusion Criteria:
- If the patient uses > 5 LO2/min at time of recruitment
- Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinolinderivates
- Pregnancy
- Breastfeeding
- Neurogenic hearing loss
- Psoriasis
- Retinopathy
- Maculopathy
- Changes in vision field
- Severe liver disease other than amoebiases
- Severe gastrointestinal, neurological or haematological disorders
- eGFR < 45 ml/min/1.73m2
- Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval
- Myasthenia Gravis
- Uses Digoxin
- Glucose-6-phosphate dehydrogenase deficiency
- Porphyria
- Hypoglycemia at any time since hospitalization
- Severe mental illness which significantly impedes cooperation
- Severe linguistic problems that significantly impedes cooperation
- Treatment with sickle alkaloids
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：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Control
This arm will receive standard care and placebo in 15 days. Azithromycin placebo: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 Hydroxychloroquine placebo: Day 1-15: 200 mg x 2 |
Placebo Azithromycin
Placebo Hydroxychloroquine
|
|
アクティブコンパレータ：Intervention
This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 Hydroxychloroquine: Day 1-15: 200 mg x 2 |
ヒドロキシクロロキン
アジスロマイシン
|
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 |
時間枠 |
|---|---|
|
Number of Days Alive and Discharged From Hospital Within 14 Days
時間枠：14 days
|
14 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
死亡
時間枠：30日
|
30日
|
|
|
死亡
時間枠：90日
|
90日
|
|
|
死亡
時間枠：365日
|
365日
|
|
|
Categorization of Hospitalization Status
時間枠：14 days
|
The patient will be categorized into one of the following 8 categories depending on status of their hospitalization:
Only one category can be "yes". |
14 days
|
|
Length of Stay in ICU
時間枠：14 days
|
Length of stay in intensive care unit.
|
14 days
|
|
Number of Participants on Non-invasive Ventilation (NIV) During Hospitalization
時間枠：14 days
|
14 days
|
|
|
Length of Hospitalization
時間枠：14 days
|
14 days
|
|
|
Days Alive and Discharged From Hospital
時間枠：30 days
|
30 days
|
|
|
Number of Readmissions (All Causes)
時間枠：30 days
|
30 days
|
|
|
Number of Days Using Non-invasive Ventilation (NIV)
時間枠：14 days
|
Number of days using non-invasive ventilation (NIV) if on NIV during hospitalization.
|
14 days
|
|
Change in Patient's Oxygen Partial Pressure
時間枠：4 days
|
PaO2 measured in arterial puncture at baseline and 4 days.
|
4 days
|
|
Change in Patient's Carbondioxide Partial Pressure
時間枠：4 days
|
PaCO2 measured in arterial puncture at baseline and 4 days.
|
4 days
|
|
Change of pH in Blood
時間枠：4 days
|
pH measured in arterial puncture at baseline and 4 days.
|
4 days
|
|
Time for no Oxygen Supplement (or Regular Oxygen Supplement "LTOT")
時間枠：14 days
|
Time for no oxygen supplement (or regular oxygen supplement "LTOT") if on oxygen during admission.
|
14 days
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Sivapalan P, Ulrik CS, Lappere TS, Eklof JV, Shaker SB, Bodtger UCS, Browatzki A, Meyer CN, Weinreich UM, Laursen CB, Biering-Sorensen T, Knop FK, Lundgren JD, Jensen JS. Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan. Trials. 2020 Oct 20;21(1):867. doi: 10.1186/s13063-020-04795-0.
- Sivapalan P, Ulrik CS, Bojesen RD, Lapperre TS, Eklof JV, Hakansson KEJ, Browatzki A, Tidemansen C, Wilcke JT, Janner J, Gottlieb V, Meteran H, Porsbjerg C, Madsen BL, Moberg M, Pedersen L, Benfield TL, Lundgren JD, Knop FK, Biering-Sorensen T, Ghanizada M, Sonne TP, Bodtger UCS, Jensen SG, Rasmussen DB, Brondum E, Tupper OD, Sorensen SW, Alstrup G, Laursen CB, Moller UW, Sverrild A, Jensen JS. Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 10;21(1):513. doi: 10.1186/s13063-020-04409-9.
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
- KronLungesyg_COVID_19_protokol
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
米国で製造され、米国から輸出された製品。
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