Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19
A Randomized, Double-blind, Two Arm, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19.
調査の概要
状態
詳細な説明
Approximately eligible 4000 subjects who are at risk of getting infected with COVID-19 (i.e. person living in same household as COVID-19 patients / healthcare workers providing direct care to COVID-19 patients) will be enrolled in to the study after due consent and based on the eligibility criteria.
Initially, 400 subjects at risk of getting infected with COVID-19 will be enrolled in the study and randomized in 1:1 ratio to receive either Mw (n=200) or placebo (n=200). After the interim analysis from the data of these 400 subjects for safety and efficacy and based on review and recommendations from DSMB / MC, modification in study design, objective or sample size will be considered.
Study duration for each subject will be of 8 weeks.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Chandigarh、インド、160012.
- 募集
- Post Graduate Institute of Medical Education and Research
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コンタクト：
- Inderpaul Singh Sehgal, DM (Pulmonary Medicine)
- 電話番号：01722756823
- メール：inderpgi@outlook.com
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主任研究者：
- Inderpaul Singh Sehgal, DM (Pulmonary Medicine)
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Delhi、インド、110029
- 募集
- All lndia Institute of Medical Science, Delhi
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コンタクト：
- Sushma Bhatnagar, MD (Anaesthesiology)
- 電話番号：919811326453
- メール：sushmabhatnagar1@gmail.com
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主任研究者：
- Sushma Bhatnagar, MD (Anaesthesiology)
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Madhya Pradesh
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Bhopal、Madhya Pradesh、インド、462024
- 募集
- All India Institute of Medical Sciences, Bhopal
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コンタクト：
- Sarman Singh, MD
- 電話番号：917552672317
- メール：director@aiimsbhopal.edu.in
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主任研究者：
- Sarman Singh, MD
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-
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:
- Healthy subjects of either gender, age ≥ 18 years, with recent history of close contact with COVID-19 patients.
- Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit.
- Female subject who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least months post-dosing.
- The subject must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.
Exclusion Criteria:
- Any febrile illness with oral temperature > 100°F within 3 days prior to randomization.
- Subject with past history of COVID-19 infection.
- Pregnant and / or lactating female subjects.
- Presence of any illness requiring hospital referral.
- Any confirmed or suspected immune-deficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency or Individuals on immunosuppressant's as Azathioprine, Cyclosporine, Mycophenolate etc.
- History of allergic reactions or anaphylaxis to Mw or its component.
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：防止
- 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 |
|---|---|
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実験的：Suspension of Mw
Intradermal suspension of Mw will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal Mw in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal Mw administered. |
Subjects randomized to Test arm will receive intraderma Mw in divided doses at least 2 cm away from first injection site in the deltoid region.
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プラセボコンパレーター：Placebo
Placebo will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal placebo in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal placebo. |
Subjects randomized to placebo arm will receive intraderma Placebo in divided doses at least 2 cm away from first injection site in the deltoid region.
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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 |
|---|---|---|
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Number of subject acquiring COVID-19 infection
時間枠：From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing..
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To compare proportion of subjects acquiring COVID-19 infection between two arms over the time till 8 weeks from administration of 1st dose
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From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing..
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)
時間枠：Till 8 weeks
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Any AE / SAE observed during the study.
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Till 8 weeks
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Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms
時間枠：From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing.
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Whether administration of Mw prevents development of Upper Respiratory Tract Infection (URTI) symptoms in close contacts of COVID-19 patients.
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From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing.
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Number of subject developing severe COVID-19 infection based on ordinal scale
時間枠：From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing
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Whether administration of Mw prevents development of severe COVID-19 infection.
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From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Anil Avhad, MBBS、Cadila Pharmaceuticals Limited
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
- CRSC20005
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
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