Cetirizine and Famotidine for COVID-19

NCT ID: NCT04836806

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2022-07-31

Brief Summary

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

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

cetirizine and famotidine

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

Group Type: EXPERIMENTAL

Cetirizine and Famotidine

Intervention Type: DRUG

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).

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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).

Interventions

Cetirizine and Famotidine

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).

Intervention Type: DRUG

Placebo

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).

Intervention Type: DRUG

Other Intervention Names

Zyrtec; Pepcid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Humphrey Lam

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Humphrey Lam, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital at Wesley Woods COVID-19 Testing Facility

Atlanta, Georgia, United States

Emory Healthcare Network Peachtree Immediate Care COVID-19 Testing Centers

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

STUDY00001722

Identifier Type: -

Identifier Source: org_study_id