Back to resultsRemotely-conducted Trial of Famotidine vs Placebo for Patients at Home With Coronavirus (COVID) of 2019 (COVID-19) (Pepcid4COV19)
Primary Purpose
Covid19
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Famotidine 20 milligram tablet
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring famotidine, Internet trial
Eligibility Criteria
Inclusion Criteria:
- - 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.
Exclusion Criteria:
- - 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.
Sites / Locations
- Pykonsult headquarters
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
famotidine
Placebo
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Serious Adverse Events
Proportion of patients who report a serious adverse event, i.e., one that causes hospitalization or death
Secondary Outcome Measures
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).
SCL18 (self-check list of 18 symptoms of COVID-19)
a) 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
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)
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
Day-60 Follow-up
Each of the same endpoints as above but evaluated 30 days after the end of treatment
Full Information
NCT ID
NCT04565392
First Posted
September 21, 2020
Last Updated
December 4, 2021
Sponsor
drpykessupplements.com
1. Study Identification
Unique Protocol Identification Number
NCT04565392
Brief Title
Remotely-conducted Trial of Famotidine vs Placebo for Patients at Home With Coronavirus (COVID) of 2019 (COVID-19)
Acronym
Pepcid4COV19
Official Title
Proof-of-concept Randomized Placebo-controlled Trial of Famotidine for Outpatients With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
drpykessupplements.com
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
famotidine, Internet trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel double-blind placebo-controlled interventional trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
study medication is Pepcid AC or matching placebo
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
famotidine
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Famotidine 20 milligram tablet
Other Intervention Name(s)
Pepcid
Intervention Description
1 tablet every 12 hours and increase to 1 tablet every 8 hours if not improved by the second day of treatment
Primary Outcome Measure Information:
Title
Clinical Course Binary Outcome
Description
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
Time Frame
30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
Title
Serious Adverse Events
Description
Proportion of patients who report a serious adverse event, i.e., one that causes hospitalization or death
Time Frame
30th (last) day of treatment, or if discontinues treatment early, last observation carried forward]
Secondary Outcome Measure Information:
Title
Time to symptomatic recovery
Description
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).
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
Title
SCL18 (self-check list of 18 symptoms of COVID-19)
Description
a) 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
Time Frame
Change from baseline at 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
Title
Patient's Global Impression of Change
Description
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)
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
Title
Adverse Events
Description
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
Time Frame
30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
Title
Day-60 Follow-up
Description
Each of the same endpoints as above but evaluated 30 days after the end of treatment
Time Frame
60 days after the start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert E Pyke, MD, PhD
Organizational Affiliation
Pykonsult LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pykonsult headquarters
City
New Fairfield
State/Province
Connecticut
ZIP/Postal Code
06812
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Remotely-conducted Trial of Famotidine vs Placebo for Patients at Home With Coronavirus (COVID) of 2019 (COVID-19)
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