Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19
NCT ID: NCT04724720
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
56 participants
INTERVENTIONAL
2021-01-19
2022-06-30
Brief Summary
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Detailed Description
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Famotidine is a histamine-2 receptor antagonist, widely available over-the-counter and at low cost, does not interact with other medications and is safely used for suppression of gastric acid production. This makes it a candidate medication for an ambulatory setting to alleviate the symptoms and shorten the symptomatic period in this population. In a case series of 10 patients with COVID-19 who self-medicated with oral famotidine, significant improvement of symptoms was associated with famotidine use after 24-48 hours. These effects were noted in patients who mostly took doses of 80mg three times daily suggesting that famotidine's action is either through its main known high affinity target, the histamine type 2 receptor or through combined inhibition of histamine receptors. Famotidine may work through reduction of H2R signaling on monocytes with a resulting reduction of cytokine release.
The working hypothesis is that famotidine will be superior to placebo in reducing disease related symptoms in non-hospitalized COVID-19 patients with mild or moderate disease. Patients will be monitored for the duration of the study, as well as be asked to record the severity of their symptoms through a daily questionnaire. Current standard of care (SOC) for patients with mild to moderate COVID-19 in the outpatient setting is to assess risk for severe disease and determine the need for an in-person visit, thromboprophylaxis and adjustment of home medication regimen. If the SOC for COVID-19 patients in the outpatient setting changes during the course of the study, a request will be submitted to modify sections of the protocol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Famotidine
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.
Famotidine
Standard or care treatment plus prescribed famotidine
Placebo
Participants in this study arm will receive standard of care and placebo for a maximum of 14 days.
Placebo
Standard of care treatment plus placebo
Interventions
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Famotidine
Standard or care treatment plus prescribed famotidine
Placebo
Standard of care treatment plus placebo
Eligibility Criteria
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Inclusion Criteria
2. Understands and agrees to comply with planned study procedures.
3. Adult ≥18 years of age at time of enrollment.
4. Subject consents to randomization.
5. Subject has confirmed COVID-19 disease \< 72 hours prior to randomization.
6. Subject has been experiencing symptoms for \>1 day but ≤7 days.
7. Able to use an electronic tablet and Bluetooth devices.
8. Subject has mild to moderate COVID-19 which is defined as (equivalent to 1, 2 on the WHO scale):
1. Patient does not require immediate admission to the hospital within 24 hrs of initial assessment
2. Patient does not require supplemental oxygen due to COVID-19
3. Patient has a score of 2 ("moderate") in at least 3 of the symptoms in the COVID- 19 symptom score
Exclusion Criteria
2. Use of famotidine within the last 30 days for any indication, e.g. medicating gastric ulcer or recent off label use for COVID-19.
3. Severe COVID-19 disease at time of enrollment requiring admission to hospital.
4. History of Stage 3 severe chronic kidney disease, i.e. eGFR of \< 60ml/min.
5. Allergy to famotidine or non-medical ingredients of the study tablet.
6. 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.
7. Patients currently using tizanidine.
8. Documented deficiency of any of the following minerals: Al, Cu, Mn, Fe and Zn.
9. Inability to perform the tasks required for the patient reported outcome measure recordings, including but not restricted to limited language proficiency.
10. Have symptoms of dysphagia or inability to swallow size #000 capsules.
18 Years
ALL
No
Sponsors
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Cold Spring Harbor Laboratory
OTHER
Northwell Health
OTHER
Responsible Party
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Tobias Janowitz
Study Principal Investigator
Principal Investigators
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Tobias Janowitz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Cold Spring Harbor Laboratory
Locations
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Northwell Health
Lake Success, New York, United States
Countries
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References
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To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
Catanzaro M, Fagiani F, Racchi M, Corsini E, Govoni S, Lanni C. Immune response in COVID-19: addressing a pharmacological challenge by targeting pathways triggered by SARS-CoV-2. Signal Transduct Target Ther. 2020 May 29;5(1):84. doi: 10.1038/s41392-020-0191-1.
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.
Geleris J, Sun Y, Platt J, Zucker J, Baldwin M, Hripcsak G, Labella A, Manson DK, Kubin C, Barr RG, Sobieszczyk ME, Schluger NW. Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19. N Engl J Med. 2020 Jun 18;382(25):2411-2418. doi: 10.1056/NEJMoa2012410. Epub 2020 May 7.
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.
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.
Food and Drug Agency Information Sheet on Famotidine, Reference ID: 4280861. 1986. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019462s039lbl.pdf.
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.
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.
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).
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.
Other Identifiers
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20-1155
Identifier Type: -
Identifier Source: org_study_id
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