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 :
Withdrawn
(lack of funding)
First Posted : September 25, 2020
Last Update Posted : December 20, 2021
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Sponsor:
drpykessupplements.com
Information provided by (Responsible Party):
drpykessupplements.com
Tracking Information | |||||
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First Submitted Date ICMJE | September 21, 2020 | ||||
First Posted Date ICMJE | September 25, 2020 | ||||
Last Update Posted Date | December 20, 2021 | ||||
Estimated Study Start Date ICMJE | May 1, 2021 | ||||
Estimated Primary Completion Date | November 1, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Negative outcome [ Time Frame: "Since you started taking CDF..." (requested duration: 14 days) ] "Did you feel worse?" (yes or no) and "Did you get hospitalized?" (yes or no)
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Remotely-conducted Trial of Famotidine vs Placebo for Patients at Home With Coronavirus (COVID) of 2019 (COVID-19) | ||||
Official Title ICMJE | Proof-of-concept Randomized Placebo-controlled Trial of Famotidine for Outpatients With COVID-19 | ||||
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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | 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
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Condition ICMJE | Covid19 | ||||
Intervention ICMJE | 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
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Withdrawn | ||||
Actual Enrollment ICMJE |
0 | ||||
Original Estimated Enrollment ICMJE |
216 | ||||
Estimated Study Completion Date ICMJE | January 31, 2022 | ||||
Estimated Primary Completion Date | November 1, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04565392 | ||||
Other Study ID Numbers ICMJE | Pykonsult 201 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | drpykessupplements.com | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | drpykessupplements.com | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | drpykessupplements.com | ||||
Verification Date | December 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |