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Cetirizine and Famotidine for COVID-19

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ClinicalTrials.gov Identifier: NCT04836806
Recruitment Status : Withdrawn (Study stopped due to issues with enrollment and lack of funding.)
First Posted : April 8, 2021
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Humphrey Lam, Emory University

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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Cetirizine and Famotidine Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Time to resolution of symptoms [ Time Frame: Day 30 ]
    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.


Secondary Outcome Measures :
  1. Severity of Symptoms [ Time Frame: Day 30 ]
    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.

  2. Time to Resolution of Individual Symptoms [ Time Frame: Day 30 ]
    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.

  3. Incidence of Hospitalization [ Time Frame: Day 30 ]
    Hospitalizations will be compared between study arms.

  4. Incidence of Intensive Care Unit (ICU) Admission [ Time Frame: Day 60 ]
    Admissions to the ICU will be compared between study arms.

  5. Incidence of Death [ Time Frame: Day 60 ]
    The number of deaths will be compared between study arms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04836806


Locations
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United States, Georgia
Emory University Hospital at Wesley Woods COVID-19 Testing Facility
Atlanta, Georgia, United States, 30329
Emory Healthcare Network Peachtree Immediate Care COVID-19 Testing Centers
Atlanta, Georgia, United States, 30339
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Humphrey Lam, MD Emory University
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Responsible Party: Humphrey Lam, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT04836806    
Other Study ID Numbers: STUDY00001722
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cetirizine
Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists