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.
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.
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
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.
Pykonsult headquarters
New Fairfield, Connecticut, United States
Robert E Pyke, MD, PhD, Principal Investigator
Pykonsult LLC