Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19

NCT04724720 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20-1155
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to evaluate the clinical efficacy of oral famotidine in symptomatic non-hospitalized patients with confirmed COVID-19. This study is expected to enroll up to 84 patients with mild to moderate symptoms divided into each of the two study arms. Clinical outcomes of the two treatment arms will be compared. This study will be conducted virtually/remotely.

Conditions

Covid-19

Keywords

Covid-19; Coronavirus; Famotidine; Outpatient; Non-Hospitalized

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of symptom resolution

  Measured by the cumulative incidence of symptom resolution using the "COVID-19 Symptom Score" derived from the answers to a questionnaire based on the NIH endorsed guidelines and the recent FDA guidelines for studying COVID-19 in an outpatient setting. A shorter version has been utilized as a scoring system in the case series of famotidine use in non-hospitalized patients with COVID-19.

  Day 28

Secondary Outcomes (11)

• Rate of symptom resolution

  Day 28

• Cumulative incidence of symptom resolution

  Day 60

• Relative change of symptoms

  Day 7

• Assessment of Serious Adverse Events

  Day 60

• Clinical improvement

  Day 28

Study Arms (2)

Famotidine

ACTIVE COMPARATOR

Participants in this study arm will receive standard of care and prescribed famotidine at 80mg TID for a maximum of 14 days, or until hospital admission.

Drug: Famotidine

Placebo

PLACEBO COMPARATOR

Participants in this study arm will receive standard of care and placebo for a maximum of 14 days.

Drug: Placebo

Interventions

Famotidine DRUG

Standard or care treatment plus prescribed famotidine

Famotidine

Placebo DRUG

Standard of care treatment plus placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
• Understands and agrees to comply with planned study procedures.
• Adult ≥18 years of age at time of enrollment.
• Subject consents to randomization.
• Subject has confirmed COVID-19 disease \< 72 hours prior to randomization.
• Subject has been experiencing symptoms for \>1 day but ≤7 days.
• Able to use an electronic tablet and Bluetooth devices.
• Subject has mild to moderate COVID-19 which is defined as (equivalent to 1, 2 on the WHO scale):
• Patient does not require immediate admission to the hospital within 24 hrs of initial assessment
• Patient does not require supplemental oxygen due to COVID-19
• Patient has a score of 2 ("moderate") in at least 3 of the symptoms in the COVID- 19 symptom score

You may not qualify if:

• Any exposure to investigational medications targeting COVID-19 during the present disease. These include recently approves antibodies (passive immunization) for treatment of COVID-19.
• Use of famotidine within the last 30 days for any indication, e.g. medicating gastric ulcer or recent off label use for COVID-19.
• Severe COVID-19 disease at time of enrollment requiring admission to hospital.
• History of Stage 3 severe chronic kidney disease, i.e. eGFR of \< 60ml/min.
• Allergy to famotidine or non-medical ingredients of the study tablet.
• Known to be immunocompromised by treatment for existing disease due to the immunomodulatory effects of famotidine and therefore possible effects on the pre- existing disease or the immunosuppressive therapy.
• Patients currently using tizanidine.
• Documented deficiency of any of the following minerals: Al, Cu, Mn, Fe and Zn.
• Inability to perform the tasks required for the patient reported outcome measure recordings, including but not restricted to limited language proficiency.
• Have symptoms of dysphagia or inability to swallow size #000 capsules.

Sponsors & Collaborators

• Northwell Health: lead
• Cold Spring Harbor Laboratory: collaborator

Study Sites (1)

Northwell Health

Lake Success, New York, 11042, United States

Location

Related Publications (12)

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  PMID: 32091533 BACKGROUND

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• Wang Y, Zhang D, Du G, Du R, Zhao J, Jin Y, Fu S, Gao L, Cheng Z, Lu Q, Hu Y, Luo G, Wang K, Lu Y, Li H, Wang S, Ruan S, Yang C, Mei C, Wang Y, Ding D, Wu F, Tang X, Ye X, Ye Y, Liu B, Yang J, Yin W, Wang A, Fan G, Zhou F, Liu Z, Gu X, Xu J, Shang L, Zhang Y, Cao L, Guo T, Wan Y, Qin H, Jiang Y, Jaki T, Hayden FG, Horby PW, Cao B, Wang C. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2020 May 16;395(10236):1569-1578. doi: 10.1016/S0140-6736(20)31022-9. Epub 2020 Apr 29.

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  PMID: 32379955 BACKGROUND

• RECOVERY Collaborative Group; Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, Staplin N, Brightling C, Ustianowski A, Elmahi E, Prudon B, Green C, Felton T, Chadwick D, Rege K, Fegan C, Chappell LC, Faust SN, Jaki T, Jeffery K, Montgomery A, Rowan K, Juszczak E, Baillie JK, Haynes R, Landray MJ. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med. 2021 Feb 25;384(8):693-704. doi: 10.1056/NEJMoa2021436. Epub 2020 Jul 17.

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• Tenforde MW, Kim SS, Lindsell CJ, Billig Rose E, Shapiro NI, Files DC, Gibbs KW, Erickson HL, Steingrub JS, Smithline HA, Gong MN, Aboodi MS, Exline MC, Henning DJ, Wilson JG, Khan A, Qadir N, Brown SM, Peltan ID, Rice TW, Hager DN, Ginde AA, Stubblefield WB, Patel MM, Self WH, Feldstein LR; IVY Network Investigators; CDC COVID-19 Response Team; IVY Network Investigators. Symptom Duration and Risk Factors for Delayed Return to Usual Health Among Outpatients with COVID-19 in a Multistate Health Care Systems Network - United States, March-June 2020. MMWR Morb Mortal Wkly Rep. 2020 Jul 31;69(30):993-998. doi: 10.15585/mmwr.mm6930e1.

  PMID: 32730238 BACKGROUND

• Food and Drug Agency Information Sheet on Famotidine, Reference ID: 4280861. 1986. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019462s039lbl.pdf.

  BACKGROUND

• Janowitz T, Gablenz E, Pattinson D, Wang TC, Conigliaro J, Tracey K, Tuveson D. Famotidine use and quantitative symptom tracking for COVID-19 in non-hospitalised patients: a case series. Gut. 2020 Sep;69(9):1592-1597. doi: 10.1136/gutjnl-2020-321852. Epub 2020 Jun 4.

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• Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987 Dec 24;317(26):1625-9. doi: 10.1056/NEJM198712243172603.

  PMID: 3317057 BACKGROUND

• Food and Drug Administration. Assessing COVID-19- Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment. (2020).

  BACKGROUND

• Schulkey CE, Litwin TR, Ellsworth G, Sansbury H, Ahmedani BK, Choi KW, Cronin RM, Kloth Y, Ashbeck AW, Sutherland S, Mapes BM, Begale M, Bhat G, King P, Marginean K, Wolfe KA, Kouame A, Raquel C, Ratsimbazafy F, Bornemeier Z, Neumeier K, Baskir R, Gebo KA, Denny J, Smoller JW, Garriock HA. Design and Implementation of the All of Us Research Program COVID-19 Participant Experience (COPE) Survey. Am J Epidemiol. 2023 Jun 2;192(6):972-986. doi: 10.1093/aje/kwad035.

  PMID: 36799620 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Famotidine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; 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

• Tobias Janowitz, MD, PhD

  Cold Spring Harbor Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Model Details: Randomized, Double-Blind Comparative Placebo Controlled Trial

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 26, 2021
• Study Start: January 19, 2021
• Primary Completion: May 3, 2021
• Study Completion: June 1, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

US (1)