Convalescent Plasma Therapy - Zurich Protocol (CPT-ZHP)
A Phase i, Open-label, Single-centre Clinical Study to Evaluate Safety and Efficacy of Passive Immunization of High-risk SARS-CoV-2 Positive Patients With Convalescent Plasma Therapy
調査の概要
詳細な説明
The outbreak of a new highly contagious and life-threatening infective disease was first reported in China in December 2019. Regardless of the undertaken containing measures, its spreading could not be effectively stopped and currently we are confronting the pandemic diffusion of a newly identified Coronavirus (SARS-CoV-2) (1). This causes a systemic disease, known as (Coronavirus Disease-19) COVID-19, characterised by a broad spectrum of clinical manifestations, including ineffective hyper-inflammation and severe pneumonia, with provisional epidemiologic data indicating a mortality rate of 0.1-15% (2). Do to the lack of vaccination, specific anti-virus sera or monoclonal antibodies, the therapeutic efforts to limit COVID-19 mostly rely on the empirical use of anti-viral drugs. Therefore, being the option of an active immunisation not available and because of the controversial efficacy of the available anti-viral therapies (3), we suggest the option of a passive immunisation for those patients who are infected with the new coronavirus and present dyspnea or a poor prognosis. The use of convalescent plasma, i.e. plasma obtained from donors who were tested positive for SARS-CoV-2 and fully recovered from the infection, could provide a rapid protection, limiting the observed evolution of COVID-19 towards life-threating manifestations (7-9).
When carried on according to standardised measures, the transfusion of plasma is highly safe (10-11) and we assume that products containing anti- SARS-CoV- 2 antibodies will provide the recipients a passive immunity through different mechanisms, including viral neutralisation, antibody-dependent cellular cytotoxicity and/or phagocytosis.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
-
Zürich、スイス、8091
- University Hospital Zurich
-
-
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:
A) Proven Sars-CoV-2 by PCR and hospitalization for COVID-19 in combination with either (1) or (2):
Age ≥50
AND (at least one):
- Pre-existing cardiovascular disease
- Diabetic disease
- Immunodeficiency/immunosuppression
- Neoplastic disease
- COPD or chronic liver disease or chronic renal failure
- Age ≥18
AND (at least one):
- SpO2 ≤ 94% on room air or requiring supplemental oxygen at screening
- Typical changes on chest x-ray and/or lung-CT scan
- Immunosuppression or neoplastic disease
B) Informed Consent as documented by signature (Appendix Informed Consent Form) of the patient or, in case of inability, of the next relative/care-taking person. In the latter case, an independent doctor will also be involved and her/his signature will be required in order to enrol the patient.
Exclusion Criteria:
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product (FFP)
- Known IgA deficiency
- Cytokine Release Syndrome grade ≥3 (see score)*
- ARDS
- Patients already hospitalized in intensive care unit and/or already receiving mechanical ventilation
- Known or suspected non-compliance, drug or alcohol abuse
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential
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: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)
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 |
|---|---|---|
|
Safety of CPT applied to COVID-19 patients
時間枠:clinical observation up to 48 hours after the last dose of plasma
|
Absence of clinical signs of Transfusion Related Lung Inflammation (TRALI) and/or allergic reactions and/or Transfusion Associated Circulatory Overload (TACO)
|
clinical observation up to 48 hours after the last dose of plasma
|
|
Safety of CPT applied to COVID-19 patients
時間枠:1 week (laboratory monitoring up to 7 days after the last administration of plasma)
|
Absence of laboratory signs of haemolytic reactions
|
1 week (laboratory monitoring up to 7 days after the last administration of plasma)
|
|
Improvement of respiratory frequency
時間枠:3 weeks after the last administration of plasma
|
Respiratory frequency will be measured at each study visit
|
3 weeks after the last administration of plasma
|
|
Improvement of O2-saturation
時間枠:3 weeks after the last administration of plasma
|
O2-Saturation will be measured at each study visit
|
3 weeks after the last administration of plasma
|
|
Improvement of Inflammatory markers (C Reactive Protein, CRP)
時間枠:3 weeks after the last administration of plasma
|
CRP will be measured at each study visit
|
3 weeks after the last administration of plasma
|
|
Improvement of Inflammatory markers (Ferritin)
時間枠:3 weeks after the last administration of plasma
|
Ferritin will be measured at each study visit
|
3 weeks after the last administration of plasma
|
|
Improvement of Inflammatory markers (IL-6)
時間枠:3 weeks after the last administration of plasma
|
IL-6 will be measured at each study visit
|
3 weeks after the last administration of plasma
|
|
Improvement of coagulation-markers (D-dimer)
時間枠:3 weeks after the last administration of plasma
|
D-Dimer will be measured at each study visit
|
3 weeks after the last administration of plasma
|
|
Improvement of coagulation-markers (Fibrinogen)
時間枠:3 weeks after the last administration of plasma
|
Fibrinogen will be measured at each study visit
|
3 weeks after the last administration of plasma
|
|
Improvement of coagulation-markers (LDH)
時間枠:3 weeks after the last administration of plasma
|
LDH will be measured at each study visit
|
3 weeks after the last administration of plasma
|
|
Prevention of ICU-admission
時間枠:3 weeks after the last administration of plasma
|
clinical conditions will be assessed throughout the study
|
3 weeks after the last administration of plasma
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Characterisation of virus reaction to plasma Therapy
時間枠:10 Weeks
|
Measurement of viral load after plasma therapy
|
10 Weeks
|
|
Characterisation of the dynamic of humoral response after therapy
時間枠:10 Weeks
|
Measurement of antibody-titres after plasma therapy
|
10 Weeks
|
|
Better characterize the the in-vivo anti-virus humoral response against SARS-CoV-2.
時間枠:10 Weeks
|
Performance of neutralisation assay after administration of plasma
|
10 Weeks
|
協力者と研究者
スポンサー
捜査官
- スタディチェア:Markus Manz, Professor、University of Zurich
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
その他の研究ID番号
- 2020-00787
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
米国で製造され、米国から輸出された製品。
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。
COVID-19(新型コロナウイルス感染症)の臨床試験
-
Pfizer積極的、募集していないCOVID-19(新型コロナウイルス感染症) | コロナウイルス病 2019 (COVID-19) | COVID-19 感染 | COVID-19 ワクチン | SARS-CoV-2 感染、COVID19 | COVID-19 ワクチン接種 | SARS-CoV-2 感染、COVID-19 | COVID-19 (コロナウイルス病 2019) | COVID-19 SARS-CoV-2 感染症アメリカ
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Pfizer募集気道疾患 | COVID-19(新型コロナウイルス感染症) | 肺炎 | 肺疾患 | コロナウイルス 病気 2019年 | コロナウイルス病 2019 (COVID-19) | COVID-19 感染 | 上気道感染症 | 気道感染症 | COVID-19 (コロナウイルス病 2019) | COVID-19 SARS-CoV-2 感染症ベルギー
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ModeX Therapeutics, An OPKO Health Company募集
-
Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)完了
-
Eggensberger OHGBavarian Health and Food Safety Authority (LGL)募集COVID-19 後の状態 | COVID-19 後 | COVID-19 後症候群 | 長い COVID-19 症候群 | COVID-19 後の状態 (PCC)ドイツ
-
Indonesia University募集COVID-19後症候群 | 長い COVID | COVID-19 後の状態 | COVID後症候群 | 長い COVID-19インドネシア
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, Indonesia募集COVID-19 パンデミック | COVID-19 ワクチン | COVID-19 ウイルス病インドネシア
-
University of Missouri, Kansas CityNational Institute on Minority Health and Health Disparities (NIMHD)積極的、募集していない
-
Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and Development; Post Covid Netwerk...募集
Convalescent plasmaの臨床試験
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Istituto Oncologico Veneto IRCCS積極的、募集していない
-
Womack Army Medical CenterUniformed Services University of the Health Sciences; The Geneva Foundation完了
-
Zimmer BiometBiomet Spain Orthopaedics S.L.終了しました
-
RDC Clinical Pty LtdKirin Holdings Company, Limited完了
-
RDC Clinical Pty LtdKirin Holdings Company, Limited完了
-
Belfast Health and Social Care TrustQueen's University, Belfast; NHS Blood and Transplant; Northern Ireland Clinical Trials Unit積極的、募集していない
-
The University of QueenslandBaxter Healthcare Corporation; Health Research Council, New Zealand; Australian Government Department...完了