An Outpatient Study Investigating Non-prescription Treatments for COVID-19

NCT04621149 | Terminated Phase 2 FDA Drug

• 1 other identifier: Profact-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a platform study to investigate the effectiveness of a variety of non-prescription approaches for the treatment of non-hospitalized adults recently tested positive for COVID-19.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Reduction in Participant Symptoms of COVID-19

  Symptoms of COVID-19 will be evaluated daily using a visual analogue scale

  3 days

Secondary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events

  28 days

• Rate of Hospitalization

  28 days

• Change in Oxygen Saturation

  8 days

• Change in Body Temperature

  8 days

Study Arms (8)

placebo

PLACEBO COMPARATOR

1 liter of filtered water

Other: placebo

chlorine dioxide aqueous solution (AS)

ACTIVE COMPARATOR

1 liter of filtered water with AS

Other: chlorine dioxide

placebo with zinc acetate (ZA)

ACTIVE COMPARATOR

1 liter of filtered water with ZA

Dietary Supplement: zinc acetate; Other: placebo

AS with ZA

ACTIVE COMPARATOR

1 liter of filtered water with AS and ZA

Other: chlorine dioxide; Dietary Supplement: zinc acetate

placebo with famotidine, lactoferrin and green tea extract (FLG)

ACTIVE COMPARATOR

1 liter of filtered water with FLG

Drug: Famotidine; Other: placebo; Dietary Supplement: lactoferrin, green tea extract

AS with FLG

ACTIVE COMPARATOR

1 liter of filtered water with AS and FLG

Other: chlorine dioxide; Drug: Famotidine; Dietary Supplement: lactoferrin, green tea extract

placebo with ZA and FLG

ACTIVE COMPARATOR

1 liter of filtered water with ZA and FLG

Dietary Supplement: zinc acetate; Drug: Famotidine; Other: placebo; Dietary Supplement: lactoferrin, green tea extract

AS with ZA and FLG

ACTIVE COMPARATOR

1 liter of filtered water with AS, ZA, and FLG

Other: chlorine dioxide; Dietary Supplement: zinc acetate; Drug: Famotidine; Dietary Supplement: lactoferrin, green tea extract

Interventions

chlorine dioxide OTHER

chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc.

AS with FLG; AS with ZA; AS with ZA and FLG; chlorine dioxide aqueous solution (AS)

zinc acetate DIETARY_SUPPLEMENT

zinc acetate lozenges have been suggested to have antiviral properties

AS with ZA; AS with ZA and FLG; placebo with ZA and FLG; placebo with zinc acetate (ZA)

Famotidine DRUG

famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid

Also known as: Pepcid

AS with FLG; AS with ZA and FLG; placebo with ZA and FLG; placebo with famotidine, lactoferrin and green tea extract (FLG)

placebo OTHER

filtered water

Also known as: filtered water

placebo; placebo with ZA and FLG; placebo with famotidine, lactoferrin and green tea extract (FLG); placebo with zinc acetate (ZA)

lactoferrin, green tea extract DIETARY_SUPPLEMENT

lactoferrin and green tea extract are dietary supplements

AS with FLG; AS with ZA and FLG; placebo with ZA and FLG; placebo with famotidine, lactoferrin and green tea extract (FLG)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 20-70
• Confirmed diagnosis of COVID-19 by positive COVID-19 test. Symptoms of a mild degree such that hospitalization is not required. Within 7 days of symptom onset.
• Ability to drink at least 1 liter of water daily and be willing to adhere to the study regimen

You may not qualify if:

• COVID-19 symptoms of a severe enough nature that requires hospitalization
• Pregnancy or lactation
• Diagnosis of diabetes mellitus
• currently taking paroxetine or digoxin
• Individuals with diabetes mellitus

Sponsors & Collaborators

• Profact, Inc.: lead

Study Sites (1)

AZ Good Health Center

Tempe, Arizona, 85282, United States

Location

Related Publications (1)

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

chlorine dioxide; Zinc Acetate; Famotidine; Lactoferrin; Tea

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jonathan Murphy, MD, MD(H)

  Profact, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a randomized, blinded placebo-controlled study with respect to the active treatment vs placebo, and randomized open-label with respect to non-prescription medicine and supplements.

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 9, 2020
• Study Start: November 15, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)