Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
cetirizine and famotidine
Participants testing positive for COVID-19 who are randomized to take cetirizine and famotidine for 10 days.
  • Drug: 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).
    Other names:
    • Zyrtec
    • Pepcid
Placebo Comparator
Placebo
Participants testing positive for COVID-19 who are randomized to take a placebo to match cetirizine and famotidine for 10 days.
  • 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).

Recruiting Locations

More Details

NCT ID
NCT04836806
Status
Withdrawn
Sponsor
Emory University

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.