Clinical trial NCT04565392: Remotely-conducted Trial of Famotidine vs Placebo for Patients at Home With Coronavirus (COVID) of 2019 (COVID-19)
Official title: Proof-of-concept Randomized Placebo-controlled Trial of Famotidine for Outpatients With COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Covid19
Keywords: famotidine
Internet trial
Lead sponsor: drpykessupplements.com
Sponsor class: INDUSTRY
First posted: 2020-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel double-blind placebo-controlled interventional trial
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Clinical Course Binary Outcome
timeFrame: 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
measure: Serious Adverse Events
timeFrame: 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward]
Secondary outcomes:
measure: Time to symptomatic recovery
timeFrame: There is no baseline rating. Outcome is rated on the 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
measure: SCL18 (self-check list of 18 symptoms of COVID-19)
timeFrame: Change from baseline at 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
measure: Patient's Global Impression of Change
timeFrame: There is no rating at baseline. Outcome is for the 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
measure: Adverse Events
timeFrame: 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward
measure: Day-60 Follow-up
timeFrame: 60 days after the start of treatment
Other outcomes:
Locations:
city: New Fairfield
country: United States
facility: Pykonsult headquarters
state: Connecticut
Study officials:
affiliation: Pykonsult LLC
name: Robert E Pyke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: