QuadraMune(TM) for Prevention of COVID-19

NCT04421391 | Unknown

• 1 other identifier: QuadraMune002
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

QuadraMune(TM) is a nutritional supplement which has previously been demonstrated to possess antiinflammatory and immune modulatory activity based on in vitro and pilot in vivo studies. The current clinical trial aims to assess in a 500 volunteer trial the efficacy of QuadraMune(TM) in reducing infection in individuals at high risk of COVID-19.

Conditions

Covid19; Coronavirus; SARS-CoV 2

Keywords

Immunology; Innate Immune System

Outcome Measures

Primary Outcomes (1)

• Prevention of COVID-19

  Prevention of COVID-19 symptoms as recorded in a daily diary

  12 Weeks

Secondary Outcomes (1)

• Safety as determined by presence or absence of Adverse Events and Serious Adverse Events

  12 Weeks

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Patients will receive 2 pills of QuadraMune(TM) daily for 12 weeks

Dietary Supplement: QuadraMune(TM)

Interventions

QuadraMune(TM) DIETARY_SUPPLEMENT

QuadraMune(TM) is a commercially available nutritional supplement

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Therapeutic Solutions International: lead

Study Sites (1)

Therapeutic Solutions International

Oceanside, California, 92056, United States

RECRUITING

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• James Veltmeyer, MD

  Therapeutic Solutions International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas E Ichim, Ph.D

CONTACT

18583534303; thomas.ichim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: June 8, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 8, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

US (1)