Clinical trial NCT04836806: Cetirizine and Famotidine for COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Covid19
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to resolution of symptoms
timeFrame: Day 30
Secondary outcomes:
measure: Severity of Symptoms
timeFrame: Day 30
measure: Time to Resolution of Individual Symptoms
timeFrame: Day 30
measure: Incidence of Hospitalization
timeFrame: Day 30
measure: Incidence of Intensive Care Unit (ICU) Admission
timeFrame: Day 60
measure: Incidence of Death
timeFrame: Day 60
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital at Wesley Woods COVID-19 Testing Facility
state: Georgia
city: Atlanta
country: United States
facility: Emory Healthcare Network Peachtree Immediate Care COVID-19 Testing Centers
state: Georgia
Study officials:
affiliation: Emory University
name: Humphrey Lam, MD
role: PRINCIPAL_INVESTIGATOR
References: