Cetirizine and Famotidine for COVID-19

Emory University

Status and phase: Withdrawn; Phase 4

Conditions: Covid19

Treatments: Drug: Cetirizine and Famotidine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04836806

STUDY00001722

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

cetirizine and famotidine

Experimental group

Description:

Participants testing positive for COVID-19 who are randomized to take cetirizine and famotidine for 10 days.

Treatment:

Drug: Cetirizine and Famotidine

Placebo

Placebo Comparator group

Description:

Participants testing positive for COVID-19 who are randomized to take a placebo to match cetirizine and famotidine for 10 days.

Treatment:

Drug: Placebo