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

Phase 2

Terminated

• Conditions: COVID-19
• Interventions: Other: placebo; Other: chlorine dioxide; Dietary Supplement: zinc acetate; Dietary Supplement: lactoferrin, green tea extract; Drug: Famotidine

• Registration Number: NCT04621149
• Lead Sponsor: Profact, Inc.

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-09
• Study Start: 2020-11-15
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	1 liter of filtered water
chlorine dioxide aqueous solution (AS)	chlorine dioxide	1 liter of filtered water with AS
placebo with zinc acetate (ZA)	zinc acetate	1 liter of filtered water with ZA
placebo with zinc acetate (ZA)	placebo	1 liter of filtered water with ZA
AS with ZA	chlorine dioxide	1 liter of filtered water with AS and ZA
AS with ZA	zinc acetate	1 liter of filtered water with AS and ZA
placebo with famotidine, lactoferrin and green tea extract (FLG)	placebo	1 liter of filtered water with FLG
placebo with famotidine, lactoferrin and green tea extract (FLG)	lactoferrin, green tea extract	1 liter of filtered water with FLG
AS with FLG	chlorine dioxide	1 liter of filtered water with AS and FLG
AS with FLG	lactoferrin, green tea extract	1 liter of filtered water with AS and FLG
placebo with ZA and FLG	zinc acetate	1 liter of filtered water with ZA and FLG
placebo with ZA and FLG	placebo	1 liter of filtered water with ZA and FLG
AS with ZA and FLG	lactoferrin, green tea extract	1 liter of filtered water with AS, ZA, and FLG
placebo with ZA and FLG	lactoferrin, green tea extract	1 liter of filtered water with ZA and FLG
AS with ZA and FLG	chlorine dioxide	1 liter of filtered water with AS, ZA, and FLG
AS with ZA and FLG	zinc acetate	1 liter of filtered water with AS, ZA, and FLG
AS with ZA and FLG	Famotidine	1 liter of filtered water with AS, ZA, and FLG
placebo with famotidine, lactoferrin and green tea extract (FLG)	Famotidine	1 liter of filtered water with FLG
placebo with ZA and FLG	Famotidine	1 liter of filtered water with ZA and FLG
AS with FLG	Famotidine	1 liter of filtered water with AS and FLG

Primary Outcome Measures

Name	Time	Method
Reduction in Participant Symptoms of COVID-19	3 days	Symptoms of COVID-19 will be evaluated daily using a visual analogue scale

Secondary Outcome Measures

Name	Time	Method
Change in Body Temperature	8 days	Body temperature
Change in Oxygen Saturation	8 days	Oxygen saturation
Rate of Hospitalization	28 days	Admission to Hospital
Incidence of Treatment-Emergent Adverse Events	28 days	Participants will complete a daily assessment for adverse events

Trial Locations

Locations (1)

AZ Good Health Center; 🇺🇸 Tempe, Arizona, United States