Cetirizine and Famotidine for COVID-19

Study Overview
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Brief Summary
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This study is a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of cetirizine and famotidine in reducing the duration of symptoms in patients with COVID-19. Secondary aims are to determine if cetirizine and famotidine decrease severity and duration of symptoms, incidence of hospitalizations, ICU admissions, and death.

Detailed Description
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COVID-19 is a disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Patients with COVID-19 may present with a myriad of symptoms ranging from fever and cough to more severe symptoms such as shortness of breath. Cetirizine and famotidine are commonly administered medications that can be found over-the-counter. They are well tolerated and have low potential for drug-drug interaction. With it's anti-inflammatory properties via modulation of proinflammatory cytokines, cetirizine may be an effective symptomatic therapeutic for COVID-19. With possible antiviral properties, famotidine may have a role in therapy as well. After a positive COVID test has been confirmed, participants with be randomized to take cetirizine and famotidine or a placebo for 10 days and the study medication will be shipped to them. Participants will record their symptoms for 30 days and any serious adverse events will be followed for up to 60 days.

Official Title
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Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Cetirizine and Famotidine in Reducing the Duration of Symptoms in Patients With COVID-19: A Pilot Study

Conditions
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Covid19

Intervention / Treatment
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* Drug: Cetirizine and Famotidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old and above positive COVID-19 test (antigen or PCR) symptomatic from COVID-19 symptoms less than or equal to 7 days Exclusion Criteria: already enrolled in another COVID-19 drug study chronically taking a H1-receptor antagonist or H2-receptor antagonist have taken H1-receptor antagonist or H2-receptor antagonist less than 72 hours from expressed interest in the study. history of an adverse reaction to H1 or H2-receptor antagonists severe liver disease severe renal disease taking steroids taking hydroxychloroquine and/or azithromycin already participating in a COVID-19 vaccine trial already received a COVID-19 vaccine symptoms greater than 7 days have had COVID-19 more than once

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cetirizine and famotidine<br>Participants testing positive for COVID-19 who are randomized to take cetirizine and famotidine for 10 days. | Drug: Cetirizine and Famotidine<br>* Participants will take 10 milligrams (mg) of cetirizine once a day and 20 mg of famotidine twice a day for 10 days (two pills in the morning and one in the evening).<br>* Other names: Pepcid;|
| Placebo Comparator: Placebo<br>Participants testing positive for COVID-19 who are randomized to take a placebo to match cetirizine and famotidine for 10 days. | Drug: Placebo<br>* Participants will take placebos to match 10 mg of cetirizine once a day and 20 mg of famotidine twice a day for 10 days (two pills in the morning and one in the evening).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of symptoms | Participants will record their oral temperature and the presence of COVID-19 symptoms of cough, shortness of breath/difficulty breathing, fatigue, myalgias, headache, loss of taste, loss of smell, sore throat, rhinorrhea, congestion, nausea/vomiting, diarrhea, and feverishness/chills, twice daily for up to 14 days. The number of days until resolution of overall symptoms of COVID-19 will be compared between study arms. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Symptoms | Participants will record their severity of COVID-19 symptoms of cough, shortness of breath/difficulty breathing, fatigue, myalgias, headache, loss of taste, loss of smell, sore throat, rhinorrhea, congestion, nausea/vomiting, diarrhea, and feverishness/chills on a four-point scale (where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe) twice daily for up to 14 days. | Day 30 | 
| Time to Resolution of Individual Symptoms | Participants will record their oral temperature and the presence of COVID-19 symptoms of cough, shortness of breath/difficulty breathing, fatigue, myalgias, headache, loss of taste, loss of smell, sore throat, rhinorrhea, congestion, nausea/vomiting, diarrhea, and feverishness/chills, twice daily for up to 14 days. The number of days until resolution of individual symptoms of COVID-19 will be compared between study arms. | Day 30 | 
| Incidence of Hospitalization | Hospitalizations will be compared between study arms. | Day 30 | 
| Incidence of Intensive Care Unit (ICU) Admission | Admissions to the ICU will be compared between study arms. | Day 60 | 
| Incidence of Death | The number of deaths will be compared between study arms. | Day 60 |