COVID-19Phase 2PROFACT-01NCT04621149
An Outpatient Study Investigating Non-prescription Treatments for COVID-19
A Phase 2 study testing chlorine dioxide, zinc acetate and Famotidine in people with COVID-19, run by Profact, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- COVID-19
- What is being tested?
- chlorine dioxide, zinc acetate and Famotidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2020to 31 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Screening Study of Candidate Non-prescription Treatments for COVID-19: A Patient-driven, Randomized, Factorial Study Evaluating Patient-reported Outcomes (PROFACT-01)
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- chlorine dioxide, zinc acetate, Famotidine, placebo, lactoferrin, green tea extract
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorine dioxideOther
chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc.
zinc acetateDietary supplement
zinc acetate lozenges have been suggested to have antiviral properties
FamotidineDrug
Also called Pepcid
famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid
placeboOther
Also called filtered water
filtered water
lactoferrin, green tea extractDietary supplement
lactoferrin and green tea extract are dietary supplements
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 1 liter of filtered water Receives: Other: placebo |
| chlorine dioxide aqueous solution (AS) | Active comparator | 1 liter of filtered water with AS Receives: Other: chlorine dioxide |
| placebo with zinc acetate (ZA) | Active comparator | 1 liter of filtered water with ZA Receives: Dietary Supplement: zinc acetate; Other: placebo |
| AS with ZA | Active comparator | 1 liter of filtered water with AS and ZA Receives: 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 Receives: Drug: Famotidine; Other: placebo; Dietary Supplement: lactoferrin, green tea extract |
| AS with FLG | Active comparator | 1 liter of filtered water with AS and FLG Receives: 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 Receives: 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 Receives: Other: chlorine dioxide; Dietary Supplement: zinc acetate; Drug: Famotidine; Dietary Supplement: lactoferrin, green tea extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Participant Symptoms of COVID-19
Symptoms of COVID-19 will be evaluated daily using a visual analogue scale
Measured: 3 days
Secondary outcomes (4)
Incidence of Treatment-Emergent Adverse Events
Participants will complete a daily assessment for adverse events
Measured: 28 days
Rate of Hospitalization
Admission to Hospital
Measured: 28 days
Change in Oxygen Saturation
Oxygen saturation
Measured: 8 days
Change in Body Temperature
Body temperature
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start15 Nov 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Why it stopped: Unable to recruit participants due to decline in COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profact, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Murphy, MD, MD(H), Principal investigator, Profact, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621149
- Sponsor's protocol ID
- Profact-01
- Acronym
- PROFACT-01
- Status last verified
- Sep 2022
- First submitted
- 5 Nov 2020
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Screening Study of Candidate Non-prescription Treatments for COVID-19: A Patient-driven, Randomized, Factorial Study Evaluating Patient-reported Outcomes (PROFACT-01)
- ClinicalTrials.gov ID
- NCT04621149
- Acronym / sponsor ID
- PROFACT-01 / Profact-01
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit participants due to decline in COVID-19.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Profact, Inc.University, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- 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.
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: placebo1 liter of filtered water |
| chlorine dioxide aqueous solution (AS) | Active comparator | Other: chlorine dioxide1 liter of filtered water with AS |
| placebo with zinc acetate (ZA) | Active comparator | Dietary Supplement: zinc acetate, Other: placebo1 liter of filtered water with ZA |
| AS with ZA | Active comparator | Other: chlorine dioxide, Dietary Supplement: zinc acetate1 liter of filtered water with AS and ZA |
| placebo with famotidine, lactoferrin and green tea extract (FLG) | Active comparator | Drug: Famotidine, Other: placebo, Dietary Supplement: lactoferrin, green tea extract1 liter of filtered water with FLG |
| AS with FLG | Active comparator | Other: chlorine dioxide, Drug: Famotidine, Dietary Supplement: lactoferrin, green tea extract1 liter of filtered water with AS and FLG |
| placebo with ZA and FLG | Active comparator | Dietary Supplement: zinc acetate, Drug: Famotidine, Other: placebo, Dietary Supplement: lactoferrin, green tea extract1 liter of filtered water with ZA and FLG |
| AS with ZA and FLG | Active comparator | Other: chlorine dioxide, Dietary Supplement: zinc acetate, Drug: Famotidine, Dietary Supplement: lactoferrin, green tea extract1 liter of filtered water with AS, ZA, and FLG |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chlorine dioxidechlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc. | Other | AS with FLG, AS with ZA, AS with ZA and FLG, chlorine dioxide aqueous solution (AS) |
| zinc acetatezinc acetate lozenges have been suggested to have antiviral properties | Dietary supplement | AS with ZA, AS with ZA and FLG, placebo with ZA and FLG, placebo with zinc acetate (ZA) |
| FamotidineAlso: Pepcidfamoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid | Drug | AS with FLG, AS with ZA and FLG, placebo with ZA and FLG, placebo with famotidine, lactoferrin and green tea extract (FLG) |
| placeboAlso: filtered waterfiltered water | Other | placebo, placebo with ZA and FLG, placebo with famotidine, lactoferrin and green tea extract (FLG), placebo with zinc acetate (ZA) |
| lactoferrin, green tea extractlactoferrin and green tea extract are dietary supplements | Dietary supplement | AS with FLG, AS with ZA and FLG, placebo with ZA and FLG, placebo with famotidine, lactoferrin and green tea extract (FLG) |
Primary outcome
Reduction in Participant Symptoms of COVID-19
Time frame: 3 days
Symptoms of COVID-19 will be evaluated daily using a visual analogue scale
4 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: 28 days
Rate of Hospitalization
Time frame: 28 days
Change in Oxygen Saturation
Time frame: 8 days
Change in Body Temperature
Time frame: 8 days
Results and safety
The study was stopped early (reason given: Unable to recruit participants due to decline in COVID-19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Derived from this study: PubMed 34473343Kreuzberger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Murphy, MD, MD(H) principal investigator
Profact, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chlorine dioxide, zinc acetate and Famotidine in people with COVID-19, run by Profact, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit participants due to decline in COVID-19.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Participant Symptoms of COVID-19 (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04621149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.