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Remotely-conducted Trial of Famotidine vs Placebo for Patients at Home With Coronavirus (COVID) of 2019 (COVID-19) (Pepcid4COV19)

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ClinicalTrials.gov Identifier: NCT04565392
Recruitment Status : Not yet recruiting
First Posted : September 25, 2020
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
drpykessupplements.com

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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Famotidine 20 milligram tablet Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel double-blind placebo-controlled interventional trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: study medication is Pepcid AC or matching placebo
Primary Purpose: Treatment
Official Title: Proof-of-concept Randomized Placebo-controlled Trial of Famotidine for Outpatients With COVID-19
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: famotidine
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
Drug: Famotidine 20 milligram tablet
1 tablet every 12 hours and increase to 1 tablet every 8 hours if not improved by the second day of treatment
Other Name: Pepcid

Placebo Comparator: Placebo
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
Drug: Famotidine 20 milligram tablet
1 tablet every 12 hours and increase to 1 tablet every 8 hours if not improved by the second day of treatment
Other Name: Pepcid




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
    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).

  2. 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 ]
    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

  3. 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 ]
    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)

  4. Adverse Events [ Time Frame: 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward ]
    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

  5. Day-60 Follow-up [ Time Frame: 60 days after the start of treatment ]
    Each of the same endpoints as above but evaluated 30 days after the end of treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. - 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
  2. - Subjects must signify that they have contacted a doctor about their current symptoms.
  3. - Subject gives informed consent for study and is willing to take the treatments and complete the scheduled evaluations.
  4. - 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:

  1. - 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].
  2. - Known sensitivity or intolerance to famotidine or another acid-blocking drug.
  3. - Lack of access to the internet at home.
  4. - 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].
  5. - Significant heart or kidney disease in the last 3 months according to subject's primary doctor
  6. - Pregnant women
  7. - 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565392


Contacts
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Contact: Robert Pyke, MD, PhD 2033993490 pykonsult@gmail.com
Contact: Robert Pyke, MD, PhD 2033120257 robertepyke@gmail.com

Locations
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United States, Connecticut
Pykonsult headquarters
New Fairfield, Connecticut, United States, 06812
Contact: Robert Pyke, MD, PhD    203-399-2390    pykonsult@gmail.com   
Sponsors and Collaborators
drpykessupplements.com
Investigators
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Principal Investigator: Robert E Pyke, MD, PhD Pykonsult LLC
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Responsible Party: drpykessupplements.com
ClinicalTrials.gov Identifier: NCT04565392    
Other Study ID Numbers: Pykonsult 201
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by drpykessupplements.com:
famotidine
Internet trial
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs