Cetirizine and Famotidine for COVID-19

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04836806
• Other study ID #: STUDY00001722
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 2021
• Est. completion date: July 2022

Study information

• Verified date: August 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Emory Healthcare Network Peachtree Immediate Care COVID-19 Testing Centers	Atlanta	Georgia
United States	Emory University Hospital at Wesley Woods COVID-19 Testing Facility	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Severity of Symptoms	Participants will record their severity 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 on a four-point scale (where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe) twice daily for up to 14 days.	Day 30
Secondary	Time to Resolution of Individual 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 individual symptoms of COVID-19 will be compared between study arms.	Day 30
Secondary	Incidence of Hospitalization	Hospitalizations will be compared between study arms.	Day 30
Secondary	Incidence of Intensive Care Unit (ICU) Admission	Admissions to the ICU will be compared between study arms.	Day 60
Secondary	Incidence of Death	The number of deaths will be compared between study arms.	Day 60