Cetirizine and Famotidine for COVID-19

NCT04836806 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: STUDY00001722
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Severity of Symptoms

  Day 30

• Time to Resolution of Individual Symptoms

  Day 30

• Incidence of Hospitalization

  Day 30

• Incidence of Intensive Care Unit (ICU) Admission

  Day 60

• Incidence of Death

  Day 60

Study Arms (2)

cetirizine and famotidine

EXPERIMENTAL

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

Drug: Cetirizine and Famotidine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Cetirizine and Famotidine 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).

Also known as: Zyrtec, Pepcid

cetirizine and famotidine

Placebo 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).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old and above
• positive COVID-19 test (antigen or PCR)
• symptomatic from COVID-19
• symptoms less than or equal to 7 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University Hospital at Wesley Woods COVID-19 Testing Facility

Atlanta, Georgia, 30329, United States

Location

Emory Healthcare Network Peachtree Immediate Care COVID-19 Testing Centers

Atlanta, Georgia, 30339, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Cetirizine; Famotidine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Officials

• Humphrey Lam, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: August 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)