QuadraMune(TM) for Prevention of COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04421391|
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Coronavirus SARS-CoV 2||Dietary Supplement: QuadraMune(TM)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of QuadraMune(TM) for Prevention of COVID-19 in High Risk Populations|
|Estimated Study Start Date :||June 8, 2020|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||November 8, 2020|
Experimental: Treatment Arm
Patients will receive 2 pills of QuadraMune(TM) daily for 12 weeks
Dietary Supplement: QuadraMune(TM)
QuadraMune(TM) is a commercially available nutritional supplement
- Prevention of COVID-19 [ Time Frame: 12 Weeks ]Prevention of COVID-19 symptoms as recorded in a daily diary
- Safety as determined by presence or absence of Adverse Events and Serious Adverse Events [ Time Frame: 12 Weeks ]Assessment of adverse events and serious adverse events will be performed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421391
|Contact: Thomas E Ichim, Ph.Demail@example.com|
|United States, California|
|Therapeutic Solutions International||Recruiting|
|Oceanside, California, United States, 92056|
|Contact: Thomas E Ichim 858-353-4303 firstname.lastname@example.org|
|Principal Investigator:||James Veltmeyer, MD||Therapeutic Solutions International|