QuadraMune(TM) for Prevention of COVID-19
Schlüsselwörter
Abstrakt
Beschreibung
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.
Termine
| Zuletzt überprüft: | 05/31/2020 |
| Zuerst eingereicht: | 06/03/2020 |
| Geschätzte Einschreibung eingereicht: | 06/04/2020 |
| Zuerst veröffentlicht: | 06/08/2020 |
| Letztes eingereichtes Update: | 06/04/2020 |
| Letztes Update veröffentlicht: | 06/08/2020 |
| Tatsächliches Startdatum der Studie: | 06/07/2020 |
| Geschätztes primäres Abschlussdatum: | 10/31/2020 |
| Voraussichtliches Abschlussdatum der Studie: | 11/07/2020 |
Zustand oder Krankheit
Intervention / Behandlung
Dietary Supplement: Treatment Arm
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| 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 |
Zulassungskriterien
| Altersberechtigt für das Studium | 18 Years Zu 18 Years |
| Studienberechtigte Geschlechter | All |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | 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. |
Ergebnis
Primäre Ergebnismaße
1. Prevention of COVID-19 [12 Weeks]
Sekundäre Ergebnismaße
1. Safety as determined by presence or absence of Adverse Events and Serious Adverse Events [12 Weeks]
