Covid19Phase 4Pepcid4COV19NCT04565392
Remotely-conducted Trial of Famotidine vs Placebo for Patients at Home With Coronavirus (COVID) of 2019 (COVID-19)
A Phase 4 study testing Famotidine 20 milligram tablet in people with Covid19, run by drpykessupplements.com at 1 site in United States.
Trial summary
Kit for reading vital signs (thermometer, wrist blood pressure device, finger oximeter) and with study drug is overnighted to qualified subjects with early symptoms of COVID-19. Subjects take a 20-milligram (mg) tab of famotidine or matching placebo twice a day, increase to 1 tablet every 8 hours if not better the 2nd… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Famotidine 20 milligram tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 31 Jan 2022
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Probable COVID-19 based on presence of at least 5 of the following symptoms of acute onset within the prior 4 days: fever, cough, sore throat, fatigue, episodic chest pain or shortness of breath with exercise, muscle or body aches, headache, loss of smell or taste, stuffy or runny nose, chills or shivering, feeling hot or feverish, nausea, diarrhea
- - Subjects must signify that they have contacted a doctor about their current symptoms.
- - Subject gives informed consent for study and is willing to take the treatments and complete the scheduled evaluations.
- - Subject has acquired a study partner who has agreed to complete the follow-up forms for the subject if the subject unable or has been hospitalized.
Who cannot join
- - Constant rather than episodic trouble breathing, Persistent pain or pressure in the chest, New confusion, Inability to wake or stay awake, Bluish lips or face, or any other severe symptom [symptoms CDC urges immediate medical care for].
- - Known sensitivity or intolerance to famotidine or another acid-blocking drug.
- - Lack of access to the internet at home.
- - Using tizanidine (Zanaflex® , a muscle relaxant), dasatinib (Sprycel®, a drug for leukemia), cefditoren (Pivoxil®, an antibiotic), or fosamprenavir or delavirdine (drugs for HIV) [Drug exclusions are per US label for Pepcid].
- - Significant heart or kidney disease in the last 3 months according to subject's primary doctor
- - Pregnant women
- - Taking any investigational medications to treat COVID-19, famotidine, anti-viral drugs or corticosteroids and not stopping them within 48 hours before starting study treatment.
- NOTE: patients are allowed to take over-the-counter agents for temporary relief of symptoms such as antipyretics and analgesics (aspirin, ibuprofen etc), cough remedies, anti-diarrheals, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pykonsult headquarters
New Fairfield, Connecticut, 06812
About this study
Official title: Proof-of-concept Randomized Placebo-controlled Trial of Famotidine for Outpatients With COVID-19
Kit for reading vital signs (thermometer, wrist blood pressure device, finger oximeter) and with study drug is overnighted to qualified subjects with early symptoms of COVID-19. Subjects take a 20-milligram (mg) tab of famotidine or matching placebo twice a day, increase to 1 tablet every 8 hours if not better the 2nd day, and continue same for 30 days. Vital signs, symptoms, compliance etc are rechecked daily for the 30 days and once again 60 days after starting study drug. Consent, baseline, and follow-up are handled via internet plus calls/texts/virtual visits from study nurse or doctor as needed for clarifications and compliance.
Read the detailed description
If an Over-The-Counter (OTC) medication could prevent worsening and hospitalization for COVID-19, it could stop the devastation wrought by the pandemic, and do so at a low cost. One OTC medication has a pre-clinical and clinical rationale to help: famotidine. For this study, 150 subjects are randomly assigned 50:50 to blinded treatment with 1 (20-milligram) tablet famotidine or matching placebo twice a day and can increase to 1 tablet three times a day. This internet-driven study requires subjects to maintain contact with and follow advice of their local MD, so it does not increase their risks from the disease. Baseline eligibility checklist follows informed consent. Subjects must have at least 5 of the standard symptoms of COVID19, be willing to keep taking study medicine and reporting results daily for 30 days, must start within the first 6 days of symptoms, and must have a study partner to complete their follow-up in case they become unable. The rate of subjects worsening or getting hospitalized is the main outcome measure.
- Conditions
- Covid19
- Being tested
- Famotidine 20 milligram tablet
- Keywords
- famotidine, Internet trial
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Famotidine 20 milligram tabletDrug
Also called Pepcid
1 tablet every 12 hours and increase to 1 tablet every 8 hours if not improved by the second day of treatment
| Study group | Role | What they receive |
|---|---|---|
| famotidine | Experimental | A 20-milligram tablet of Pepcid in the morning and evening the first day, to be increased thereafter to one tablet every 8 hours if not improving Receives: Drug: Famotidine 20 milligram tablet |
| Placebo | Placebo comparator | A placebo tablet to match a 20-milligram (mg) tablet of Pepcid in the morning and evening the first day, to be increased thereafter to one tablet every 8 hours if not improving Receives: Drug: Famotidine 20 milligram tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Course Binary Outcome
Proportion of patients who self-rate as 6 on Patients Global Impression or are hospitalized for COVID-19 or similar symptoms or seek medical help for worsening symptoms, or get short of breath and have oxygen saturation below 90%, or die of COVID-19
Measured: 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
Serious Adverse Events
Proportion of patients who report a serious adverse event, i.e., one that causes hospitalization or death
Measured: 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward]
Secondary outcomes (5)
Time to symptomatic recovery
Proportion who answer the daily Global Recovery Question affirmatively: "Have you returned to your usual health (before your COVID-19 illness)? yes/no" if verified on the same day's evaluation by at least one category of improvement in each of the symptoms endorsed at baseline on the SCL18 (see Outcome 4).
Measured: There is no baseline rating. Outcome is rated on the 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
SCL18 (self-check list of 18 symptoms of COVID-19)
- mean change in total (18-item) score since baseline; b) proportion self-rating each item (symptom) at a lower or 0 intensity value than at baseline; c) subtotal on: Major Acute Physical Symptoms (SCL18 #2, Pains in heart or chest, #4 Nausea, vomiting or upset stomach, #6 Sore throat, #7 Cough, #9 Chills or shivering, #11 Diarrhea, or #13, Trouble getting your breath), d) physical symptoms (first 13 items of SCL18), f) cognitive symptoms (last 5 items of SCL18). Each item is rated as (0) not at all, (1) a little bit (2) moderately, (3) quite a bit, or (4) extremely
Measured: Change from baseline at 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
Patient's Global Impression of Change
Proportions rating Patient's Global Impression of Change: as 1-4; as 1-3; as 1-2; as 6 (answer set: 1, very much improved, 2/much improved, 3/moderately improved, 4/minimally improved, 5/about the same, 6/worse)
Measured: There is no rating at baseline. Outcome is for the 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
Adverse Events
Proportions of patients reporting new or worsening symptoms: a) any adverse event; b) the expected adverse events for famotidine (headache, dizziness, constipation, diarrhea); c) other adverse events, grouped by type
Measured: 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
Day-60 Follow-up
Each of the same endpoints as above but evaluated 30 days after the end of treatment
Measured: 60 days after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 May 2021 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel double-blind placebo-controlled interventional trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- drpykessupplements.com
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert E Pyke, MD, PhD, Principal investigator, Pykonsult LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565392
- Sponsor's protocol ID
- Pykonsult 201
- Acronym
- Pepcid4COV19
- Status last verified
- Dec 2021
- First submitted
- 21 Sep 2020
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept Randomized Placebo-controlled Trial of Famotidine for Outpatients With COVID-19
- ClinicalTrials.gov ID
- NCT04565392
- Acronym / sponsor ID
- Pepcid4COV19 / Pykonsult 201
- Conditions
- Covid19
- Keywords
- famotidine, Internet trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- drpykessupplements.comIndustry (pharma, biotech, devices)
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 25 Sep 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.
Kit for reading vital signs (thermometer, wrist blood pressure device, finger oximeter) and with study drug is overnighted to qualified subjects with early symptoms of COVID-19. Subjects take a 20-milligram (mg) tab of famotidine or matching placebo twice a day, increase to 1 tablet every 8 hours if not better the 2nd day, and continue same for 30 days. Vital signs, symptoms, compliance etc are rechecked daily for the 30 days and once again 60 days after starting study drug. Consent, baseline, and follow-up are handled via internet plus calls/texts/virtual visits from study nurse or doctor as needed for clarifications and compliance.
Detailed description
If an Over-The-Counter (OTC) medication could prevent worsening and hospitalization for COVID-19, it could stop the devastation wrought by the pandemic, and do so at a low cost. One OTC medication has a pre-clinical and clinical rationale to help: famotidine. For this study, 150 subjects are randomly assigned 50:50 to blinded treatment with 1 (20-milligram) tablet famotidine or matching placebo twice a day and can increase to 1 tablet three times a day. This internet-driven study requires subjects to maintain contact with and follow advice of their local MD, so it does not increase their risks from the disease. Baseline eligibility checklist follows informed consent. Subjects must have at least 5 of the standard symptoms of COVID19, be willing to keep taking study medicine and reporting results daily for 30 days, must start within the first 6 days of symptoms, and must have a study partner to complete their follow-up in case they become unable. The rate of subjects worsening or getting hospitalized is the main outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel double-blind placebo-controlled interventional trial
| Arm | Type | Receives |
|---|---|---|
| famotidine | Experimental | Drug: Famotidine 20 milligram tabletA 20-milligram tablet of Pepcid in the morning and evening the first day, to be increased thereafter to one tablet every 8 hours if not improving |
| Placebo | Placebo comparator | Drug: Famotidine 20 milligram tabletA placebo tablet to match a 20-milligram (mg) tablet of Pepcid in the morning and evening the first day, to be increased thereafter to one tablet every 8 hours if not improving |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Probable COVID-19 based on presence of at least 5 of the following symptoms of acute onset within the prior 4 days: fever, cough, sore throat, fatigue, episodic chest pain or shortness of breath with exercise, muscle or body aches, headache, loss of smell or taste, stuffy or runny nose, chills or shivering, feeling hot or feverish, nausea, diarrhea
- - Subjects must signify that they have contacted a doctor about their current symptoms.
- - Subject gives informed consent for study and is willing to take the treatments and complete the scheduled evaluations.
- - Subject has acquired a study partner who has agreed to complete the follow-up forms for the subject if the subject unable or has been hospitalized.
Key exclusion criteria (8 listed)
- - Constant rather than episodic trouble breathing, Persistent pain or pressure in the chest, New confusion, Inability to wake or stay awake, Bluish lips or face, or any other severe symptom [symptoms CDC urges immediate medical care for].
- - Known sensitivity or intolerance to famotidine or another acid-blocking drug.
- - Lack of access to the internet at home.
- - Using tizanidine (Zanaflex® , a muscle relaxant), dasatinib (Sprycel®, a drug for leukemia), cefditoren (Pivoxil®, an antibiotic), or fosamprenavir or delavirdine (drugs for HIV) [Drug exclusions are per US label for Pepcid].
- - Significant heart or kidney disease in the last 3 months according to subject's primary doctor
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 |
|---|---|---|
| Famotidine 20 milligram tabletAlso: Pepcid1 tablet every 12 hours and increase to 1 tablet every 8 hours if not improved by the second day of treatment | Drug | Placebo, famotidine |
Primary outcome
Clinical Course Binary Outcome
Time frame: 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
Proportion of patients who self-rate as 6 on Patients Global Impression or are hospitalized for COVID-19 or similar symptoms or seek medical help for worsening symptoms, or get short of breath and have oxygen saturation below 90%, or die of COVID-19
Serious Adverse Events
Time frame: 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward]
Proportion of patients who report a serious adverse event, i.e., one that causes hospitalization or death
5 secondary outcomes
Time to symptomatic recovery
Time frame: There is no baseline rating. Outcome is rated on the 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
SCL18 (self-check list of 18 symptoms of COVID-19)
Time frame: Change from baseline at 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
Patient's Global Impression of Change
Time frame: There is no rating at baseline. Outcome is for the 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
Adverse Events
Time frame: 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
Day-60 Follow-up
Time frame: 60 days after the start of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
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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.
Robert E Pyke, MD, PhD principal investigator
Pykonsult LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Famotidine 20 milligram tablet in people with Covid19, run by drpykessupplements.com 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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 20 Dec 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 withdrawn before enrolling participants, so there are no results.
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?
Clinical Course Binary Outcome (time frame: 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2021.