Not provided
Not provided
Not provided
Not provided
Not provided
Study stopped due to issues with enrollment and lack of funding.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cetirizine and famotidine | Experimental | Participants testing positive for COVID-19 who are randomized to take cetirizine and famotidine for 10 days. |
|
| Placebo | Placebo Comparator | Participants testing positive for COVID-19 who are randomized to take a placebo to match cetirizine and famotidine for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Humphrey Lam, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital at Wesley Woods COVID-19 Testing Facility | Atlanta | Georgia | 30329 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D017332 | Cetirizine |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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). |
|
| 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 |
| Incidence of Hospitalization | Hospitalizations will be compared between study arms. | Day 30 |
| Incidence of Intensive Care Unit (ICU) Admission | Admissions to the ICU will be compared between study arms. | Day 60 |
| Incidence of Death | The number of deaths will be compared between study arms. | Day 60 |
| Emory Healthcare Network Peachtree Immediate Care COVID-19 Testing Centers |
| Atlanta |
| Georgia |
| 30339 |
| United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |