COVID-19
Conditions
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.
Interventions
OTHERchlorine dioxide
chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc.
DIETARY_SUPPLEMENTzinc acetate
zinc acetate lozenges have been suggested to have antiviral properties
DRUGFamotidine
famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid
OTHERplacebo
filtered water
DIETARY_SUPPLEMENTlactoferrin, green tea extract
lactoferrin and green tea extract are dietary supplements
Sponsors
Profact, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Participant Symptoms of COVID-19 | 3 days | Symptoms of COVID-19 will be evaluated daily using a visual analogue scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 28 days | Participants will complete a daily assessment for adverse events |
| Rate of Hospitalization | 28 days | Admission to Hospital |
| Change in Oxygen Saturation | 8 days | Oxygen saturation |
| Change in Body Temperature | 8 days | Body temperature |
Countries
United States
Outcome results
None listed