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

NCT04565392 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: Pykonsult 201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

famotidine; Internet trial

Outcome Measures

Primary Outcomes (2)

• 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

  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

  30th (last) day of treatment, or if discontinues treatment early, last observation carried forward]

Secondary Outcomes (5)

• Time to symptomatic recovery

  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)

  Change from baseline at 30th (last) day of treatment, or if discontinues treatment early, last observation carried forward

• Patient's Global Impression of Change

  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

  30th (last) day of treatment, or if discontinues treatment early, last observation carried forward

• Day-60 Follow-up

  60 days after the start of treatment

Study Arms (2)

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

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

Drug: Famotidine 20 milligram tablet

Interventions

Famotidine 20 milligram tablet DRUG

1 tablet every 12 hours and increase to 1 tablet every 8 hours if not improved by the second day of treatment

Also known as: Pepcid

Placebo; famotidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.
• \- 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.

Sponsors & Collaborators

• drpykessupplements.com: lead

Study Sites (1)

Pykonsult headquarters

New Fairfield, Connecticut, 06812, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Famotidine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Robert E Pyke, MD, PhD

  Pykonsult LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: study medication is Pepcid AC or matching placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel double-blind placebo-controlled interventional trial

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: May 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: January 31, 2022
• Last Updated: December 20, 2021

Record last verified: 2021-12

Locations

US (1)