An Outpatient Study Investigating Non-prescription Treatments for COVID-19 (PROFACT-01)

Profact, Inc.

Status and phase: Terminated; Phase 2

Conditions: COVID-19

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04621149

Profact-01

Details and patient eligibility

About

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.

Full description

This study will screen for the activity of a variety of non-prescription approaches for the treatment of non-hospitalized adults recently diagnosed with COVID-19. This will be a randomized, blinded placebo-controlled study with respect to the active treatment (chlorine dioxide) vs placebo, and randomized open-label with respect to a non-prescription medication (famotidine) and supplements including zinc, EGCG and lactoferrin. Treatment will last for 7 days.

Enrollment: 10 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 20-70
4. 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.
5. Ability to drink at least 1 liter of water daily and be willing to adhere to the study regimen

Exclusion criteria

1. COVID-19 symptoms of a severe enough nature that requires hospitalization
2. Pregnancy or lactation
3. Diagnosis of diabetes mellitus
4. currently taking paroxetine or digoxin
5. Individuals with diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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10 participants in 8 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

1 liter of filtered water

Treatment:

Other: placebo

chlorine dioxide aqueous solution (AS)

Active Comparator group

Description:

1 liter of filtered water with AS

Treatment:

Other: chlorine dioxide

placebo with zinc acetate (ZA)

Active Comparator group

Description:

1 liter of filtered water with ZA

Treatment:

Dietary Supplement: zinc acetate

Other: placebo

AS with ZA

Active Comparator group

Description:

1 liter of filtered water with AS and ZA

Treatment:

Other: chlorine dioxide

Dietary Supplement: zinc acetate

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

Active Comparator group

Description:

1 liter of filtered water with FLG

Treatment:

Dietary Supplement: lactoferrin, green tea extract

Drug: Famotidine

Other: placebo

AS with FLG

Active Comparator group

Description:

1 liter of filtered water with AS and FLG

Treatment:

Other: chlorine dioxide

Dietary Supplement: lactoferrin, green tea extract

Drug: Famotidine

placebo with ZA and FLG

Active Comparator group

Description:

1 liter of filtered water with ZA and FLG

Treatment:

Dietary Supplement: zinc acetate

Dietary Supplement: lactoferrin, green tea extract

Drug: Famotidine

Other: placebo

AS with ZA and FLG

Active Comparator group

Description:

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

Treatment:

Other: chlorine dioxide

Dietary Supplement: zinc acetate

Dietary Supplement: lactoferrin, green tea extract

Drug: Famotidine