Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19
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|ClinicalTrials.gov Identifier: NCT04724720|
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : February 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid-19||Drug: Famotidine Drug: Placebo||Phase 2|
The outbreak of coronavirus disease 2019 (COVID 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was first reported in Wuhan, China, in 31 December 2019 and was declared as a global health emergency on 30 January 2020. Currently, there are no definitive vaccine, therapeutic antibody, or antiviral drug countermeasures currently authorized by the FDA for prevention or treatment of mild to moderate COVID-19 disease.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, Double-Blind Comparative Placebo Controlled Trial|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blind, Comparative Trial of the Safety and Efficacy of Famotidine vs Placebo for the Treatment of Non-Hospitalized Symptomatic Adults With COVID-19|
|Actual Study Start Date :||January 19, 2021|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: 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.
Standard or care treatment plus prescribed famotidine
Placebo Comparator: Placebo
Participants in this study arm will receive standard of care and placebo for a maximum of 14 days.
Standard of care treatment plus placebo
- Cumulative incidence of symptom resolution [ Time Frame: Day 28 ]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.
- Cumulative incidence of symptom resolution [ Time Frame: Day 60 ]Assessed using the "COVID-19 Symptom Score"
- Relative change of symptoms [ Time Frame: Day 7 ]Assessed using the "COVID-19 Symptom Score"
- Assessment of Serious Adverse Events [ Time Frame: Day 60 ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
- Clinical improvement [ Time Frame: Day 28 ]Assessed using the 9-point ordinal scale recommended by the WHO for trials enrolling patients with COVID-19.
- Improvement in peripheral oxygen saturation [ Time Frame: Day 7 ]Measured by pulse oximetry in % oxygen saturation.
- Mortality [ Time Frame: Day 28 ]
- Comparative proportions of hospitalized patients [ Time Frame: Day 0-28 ]Measured by the proportions of patients having been hospitalized by Day 28.
- Change in systemic inflammation [ Time Frame: Day 7, 14, and 28. ]Measured by CRP [mg/L]
- Change in systemic inflammation [ Time Frame: Day 7, 14, and 28. ]procalcitonin [microg/L]
- Change in systemic inflammation [ Time Frame: Day 7, 14, and 28. ]ferritin [microg/L]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04724720
|Contact: Tobias Janowitz, MD, PhDemail@example.com|
|Contact: Christina Brennan, MDfirstname.lastname@example.org|
|United States, New York|
|Lake Success, New York, United States, 11042|
|Contact: Christina Brennan, MD 516-881-7067 email@example.com|
|Principal Investigator: Tobias Janowitz, Ph.D|
|Sub-Investigator: Christina Brennan, MD|
|Sub-Investigator: Sandeep Nadella, MD|
|Sub-Investigator: Joseph Conigliaro, MD|
|Principal Investigator:||Tobias Janowitz, MD, PhD||Cold Spring Harbor Laboratory|