QuadraMune(TM) for Prevention of COVID-19
キーワード
概要
説明
QuadraMune(TM) is composed of 4 natural ingredients.
Pterostilbene is an analogue of resveratrol, and has been shown to possess antiinflammatory activity. Additionally, this compound suppresses macrophage activation while enhancing NK activity.
Epigallocatechin gallate (EGCG) is one of the active ingredients in green tea and has been shown to act as an activator of T cells, and a suppressor of neutrophil mediated inflammation.
Sulforaphane is derived from broccoli and studies have shown that it protects lungs from inflammatory pathology.
Thymoquinone, which is chemically related to hydroxychloroquine, possessing antiviral effects and increases NK activity.
QuadraMune is a combination of these ingredients and is believed to possess superior in vitro and in vivo therapeutic properties as compared to when the ingredients are administered individually.
The study aims to assess preventative effects of QuadraMune(TM) administration for 12 weeks.
日付
| 最終確認済み: | 05/31/2020 |
| 最初に提出された: | 06/03/2020 |
| 提出された推定登録数: | 06/04/2020 |
| 最初の投稿: | 06/08/2020 |
| 最終更新が送信されました: | 06/04/2020 |
| 最終更新日: | 06/08/2020 |
| 実際の研究開始日: | 06/07/2020 |
| 一次完了予定日: | 10/31/2020 |
| 研究完了予定日: | 11/07/2020 |
状態または病気
介入/治療
Dietary Supplement: Treatment Arm
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Treatment Arm Patients will receive 2 pills of QuadraMune(TM) daily for 12 weeks | Dietary Supplement: Treatment Arm QuadraMune(TM) is a commercially available nutritional supplement |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Informed consent, provided electronically via the EDC, demonstrating the subject understands the procedures required for the study and the purpose of the study Male or female patients 18 years of age or older that are considered to be high-risk individuals. - High-risk individuals are defined as all health care workers in hospitals, clinics, and emergency rooms, and medical facilities. - Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. At least one of these must be a barrier method. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized) Exclusion Criteria: - Refusal to provide informed consent Any previous positive test for COVID-19 by RT-PCR Symptomatic for COVID-19 Diarrhea prior to the start of treatment Type I or II diabetes Atherosclerotic Coronary Artery Disease Any contraindication for treatment with hydroxychloroquine including: Hypoglycemia G6PD deficiency Porphyria Anemia Neutropenia Alcoholism Myasthenia Gravis Skeletal muscle disorder Maculopathy Changes in the visual field Liver disease, with ALT/AST > 2.5 upper limit normal and total bilirubin >2.5 upper limit normal Psoriasis Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject. |
結果
主な結果の測定
1. Prevention of COVID-19 [12 Weeks]
二次的な結果の測定
1. Safety as determined by presence or absence of Adverse Events and Serious Adverse Events [12 Weeks]
