COVID-19Phase 3NCT05946551
Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial
A Phase 3 study testing Cetirizine and Famotidine in people with COVID-19, run by Emory University at 4 sites in United States.
Trial summary
The primary objective of this study is to assess the feasibility and acceptability of methods and procedures to be employed in a larger scale decentralized platform adaptive randomized clinical trial in patients with a history of a Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Polymerase Chain Reaction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Cetirizine and Famotidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Mar 2024to 24 Jun 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age with a history of a SARS-CoV-2 PCR positive test and/or medical records from a healthcare provider that coincides with the diagnosis of long-COVID
- New or worsened symptoms since the onset of COVID-19 that are persistent at the time of enrollment and have lasted for ≥ 12 weeks (including at least one of the following: fatigue, post-exertional malaise (PEM), headache, brain fog, sleep disturbance, dysautonomia.
- Confirmation of negative urine or serum human chorionic gonadotropin (HCG) (pregnancy) test in women of childbearing potential
- Willing to use appropriate contraceptives for female and male subjects for the duration of the study
- Has an address (for mailing of study drug) in the state of Georgia
- Able to swallow capsules
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- Has reliable access to a mobile phone, tablet, laptop, or desktop computer capable of connecting to the internet via Wi-Fi or a data plan
- Available lab work (CBC and CMP) after the onset of long COVID symptoms
- Willing and able to comply with scheduled visits, treatment plan, and other study procedures including receiving either intervention or placebo
- Willing to not take any of the study medications while enrolled in the study except for essential needs as prescribed by a healthcare provider
Who cannot join
- No post-acute COVID-19 symptoms (PASC) symptoms at the time of enrollment or PASC symptoms present <12 weeks at the time of enrollment
- Inability to provide own informed consent
- Currently Hospitalized
- For women of childbearing potential (WOCBP), currently pregnant or plans to become pregnant during the study period; for males with partners of childbearing potential (OCBP), plans to become pregnant during the study period
- Actively enrolled in another Long COVID/PASC interventional trial or participation in another interventional clinical trial in the last 30 days or planned during the trial period
- Unstable medical comorbidities (e.g., decompensated cirrhosis, stage III-IV chronic kidney disease, New York Heart Association (NYHA) class III congestive heart failure), per the patient report, telemedicine physical exam, baseline laboratory values (hematology and extended chemistry panels) and/or medical records
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- Other medical conditions occurring after the onset of COVID-19 that can otherwise account for PASC-type symptoms
- Currently immunocompromised from the following: solid organ transplant, bone marrow transplant (BMT), high dose steroids (>20mg prednisone per day), immune modulators, or chemotherapy
- Currently taking opioid analgesics, undergoing treatment for opioid addiction, or taking any other prohibited concomitant medication
- Opioid dependence or withdrawal syndrome
- Known sensitivity or adverse reaction to H1 or H2 receptor antagonists, or medication components
- Suspected or confirmed pregnancy or breastfeeding
- Participants already on H1 or H2 receptor antagonists within three (3) months of randomization
- Currently receiving other therapies to treat COVID-19 or Long COVID symptoms, e.g., convalescent plasma, remdesivir, Paxlovid
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Grady Health System
Atlanta, Georgia, 30303
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory Hospital
Atlanta, Georgia, 30322
Metro-Atlanta
Atlanta, Georgia, 30340
About this study
Official title: Feasibility Assessment of a Decentralized Platform Adaptive Double-Blind, Randomized Controlled Trial Investigating Repurposed Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC)
The primary objective of this study is to assess the feasibility and acceptability of methods and procedures to be employed in a larger scale decentralized platform adaptive randomized clinical trial in patients with a history of a Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Polymerase Chain Reaction (PCR) positive test and/or medical records from a healthcare provider that coincides with the diagnosis of long-COVID.
Read the detailed description
Fully decentralized single-center, double-blind, randomized, placebo-controlled pilot feasibility trial for patients reporting symptoms consistent with at least one of the following PASC symptoms: Brain fog, Fatigue, Headache, Sleep Disturbance, Post-exertional Malaise (PEM), or Dysautonomia.
Participants' interactions with study staff and the study visits will occur primarily via REDCap and Zoom. Informed consent will be conducted remotely via Zoom and obtained electronically in REDCap. Subjects will complete protocol-required logs, questionnaires, and surveys in REDCap. Dose tolerability assessments will occur via televisit preferably, or phone if necessary.
Following informed consent, subjects will enter a 4-week screening period during which medical records will be obtained and reviewed. At baseline (Day -28) subjects will complete a battery of tests consisting of the World Health Organization Disability Assessment Schedule (WHODAS) 2.0, Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a, Insomnia Severity Scale, PROMIS Cognitive Function 6A, DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM) Short Form, Headache Diary, COMPASS 31, and Self-reported persistent symptoms questionnaire. The headache diary requires daily tracking for 7 days (i.e., Day -28- Day -22).
Subjects who complete the screening phase will proceed to randomization where they will be randomized 2:1 to either histamine receptor antagonists (cetirizine and famotidine) or matching placebos. Emory University's Investigational Drug Services (IDS) will conduct the randomization and will overnight via national courier the assigned medication to the study subject. The treatment phase of 12 weeks starts upon ingestion of the first dose.
Cetirizine and famotidine will be supplied as 10mg capsules and 20mg capsules respectively. Dosing for the entire treatment period is one 10mg capsule cetirizine or placebo once daily, preferably at bedtime, and one 20mg capsule famotidine or placebo twice daily, as near as possible to the same time every day. Dose tolerability will be assessed on Day 14 via televisit or phone call. If the dose of either IP is not tolerated, subjects will be removed from the study. If the doses are tolerated, subjects will be resupplied and tolerability assessed per protocol.
Throughout the treatment phase subjects in all arms will complete the symptom questionnaire, adverse event, study drug adherence, and concomitant medication logs weekly. All subjects will complete the full battery of tests on Days 42, 63, and 84 (Weeks 6, 9, and 12). Subjects will have a +/- 3-day window in which to complete the battery. However, the headache diary requires daily tracking for the 7 days preceding Days 43, 63, and 84. On Day 84 all subjects will complete an end-of-study survey assessing their thoughts and feelings about the study methods and procedures.
- Conditions
- COVID-19
- Being tested
- Cetirizine, Famotidine, Cetirizine Placebo, Famotidine Placebo
- Keywords
- Long COVID-19
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetirizineDrug
Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime.
FamotidineDrug
Also called HRA
Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.
Cetirizine PlaceboDrug
The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine.
Famotidine PlaceboDrug
The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
| Study group | Role | What they receive |
|---|---|---|
| HRA Treatment Arm | Experimental | Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Receives: Drug: Cetirizine; Drug: Famotidine |
| Placebo Arm | Placebo comparator | The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Receives: Drug: Cetirizine Placebo; Drug: Famotidine Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Had Any Confusion Over How to Take the Study Drug, Including Which Pill to Take, When to Take it, or How Many to Take
The number of participants that had any confusion over how to take the study drug, including which pill to take, when to take it, or how many to take will be recorded as part of the end-of-study survey.
Measured: End of the Treatment Phase at 12 weeks
Number of Participants That Had Trouble Adhering to the Study Drug Schedule
The number of participants that had trouble adhering to the study drug schedule will be recorded as part of the end-of-study survey.
Measured: End of the Treatment Phase at 12 weeks
Number of Participants That Had Any Difficulty Using the REDCap Interface.
The number of participants that had any difficulty using the REDCap interface will be recorded as part of the end-of-study survey.
Measured: End of the Treatment Phase at 12 weeks
Number of Participants That Prefer Participating in This Virtual Study
The number of participants that prefer participating in this virtual study compared to participating in an in-person study hosted at a medical center will be recorded as part of the end-of-study survey.
Measured: End of the Treatment Phase at 12 weeks
Number of Participants Satisfied With Their Opportunities to Interact With Study Staff
The number of participants satisfied with their opportunities to interact with study staff will be recorded as part of the end-of-study survey.
Measured: End of the Treatment Phase at 12 weeks
Number of Participants That Felt They Could Reach Study Staff if Needed
The number of participants that felt they could reach study staff if needed will be recorded as part of the end-of-study survey.
Measured: End of the Treatment Phase at 12 weeks
Number of Participants That Felt That Study Staff Was Available and Easy to Contact to Report Any Adverse Effects
The number of participants that felt that study staff was available and easy to contact to report any adverse effects that they experienced from the medication will be recorded as part of the end-of-study survey.
Measured: End of the Treatment Phase at 12 weeks
Number of Participants That Felt That the Amount of Information Collected in Each Series of Surveys Was Acceptable
The number of participants that felt that the amount of information collected in each series of surveys was acceptable will be recorded as part of the end-of-study survey.
Measured: End of the Treatment Phase at 12 weeks
Number of Participants That Felt That the Frequency in Which the Information Was Collected Was Acceptable
The number of participants that felt that the frequency in which the information was collected was acceptable will be recorded as part of the end-of-study survey.
Measured: End of the Treatment Phase at 12 weeks
Improvement Rating
Participants will be asked how much they feel they improved from this treatment over the last 12 week using a scale from 1 to 5, with 5 being complete improvement (better outcome) and 1 being no improvement.
Measured: End of the Treatment Phase at 12 weeks
Quality of Life (QoL) Score Rating
Participants will be asked how much their quality of life was impacted by changes to their health during the study. On a scale of 1 to 5 with 5 being the most impacted (better outcome) and 1 being not at all impacted by changes to their health.
Measured: End of the Treatment Phase at 12 weeks
Interest Score
Participants will be asked how interested they are in continuing treatment with the study medication after the study. On a scale of 1 to 5, with 5 being completely interested (better outcome) and 1 being completely uninterested.
Measured: End of the Treatment Phase at 12 weeks
Secondary outcomes (8)
Proportion of Survey Completion
Percentage of participants who complete 70% of surveys will be assessed
Measured: End of the Treatment Phase at 12 weeks
Proportion of Study Drug Adherence
Percentage of participants who complete 70% of doses will be assessed
Measured: End of the Treatment Phase at 12 weeks
Proportion of Lost to Follow Up (LFUP)
Percentage of participants Lost to Follow Up (LFUP) will be assessed
Measured: End of the Treatment Phase at 12 weeks
Proportion of Voluntary Termination
Percentage of participants that voluntarily terminate participation will be assessed
Measured: End of the Treatment Phase at 12 weeks
Adverse Events (AEs) Incidence
The mean number of adverse events in the treatment arms will be compared to those in the placebo arm.
Measured: End of the Treatment Phase at 12 weeks
Serious, Unexpected Suspected Adverse Reactions (SUSAR) Incidence
The number of SUSARs in the treatment arms versus the placebo arm will be recorded.
Measured: End of the Treatment Phase at 12 weeks
Study-wide Serious Adverse Events (SAEs) Incidence
The total number of SAEs in the treatment arms versus the placebo arm will be recorded.
Measured: End of the Treatment Phase at 12 weeks
Number of Discontinuations or Temporary Suspensions of IP
The total number of participants who discontinue any of the treatment arms versus the placebo arm will be recorded.
Measured: End of the Treatment Phase at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start8 Mar 2024
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Why it stopped: Study was terminated due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- CURE Drug Repurposing Collaboratory (CDRC)
- Responsible party
- Principal investigator, Tiffany A Walker, Emory University
- Investigators
- Tiffany Walker, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946551
- Sponsor's protocol ID
- STUDY00005537
- Status last verified
- Jun 2025
- First submitted
- 12 Jul 2023
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified datasets may be available to external researchers following final analyses. Requests will be evaluated on a case-by-case basis by PI. No data will be released without proof of Institutional Review Board (IRB) approval or determination. Agreements as required by local policies will be completed when necessary.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Assessment of a Decentralized Platform Adaptive Double-Blind, Randomized Controlled Trial Investigating Repurposed Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC)
- ClinicalTrials.gov ID
- NCT05946551
- Acronym / sponsor ID
- STUDY00005537
- Conditions
- COVID-19
- Keywords
- Long COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to lack of funding.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- CURE Drug Repurposing Collaboratory (CDRC)
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Posted 17 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the feasibility and acceptability of methods and procedures to be employed in a larger scale decentralized platform adaptive randomized clinical trial in patients with a history of a Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Polymerase Chain Reaction (PCR) positive test and/or medical records from a healthcare provider that coincides with the diagnosis of long-COVID.
Detailed description
Fully decentralized single-center, double-blind, randomized, placebo-controlled pilot feasibility trial for patients reporting symptoms consistent with at least one of the following PASC symptoms: Brain fog, Fatigue, Headache, Sleep Disturbance, Post-exertional Malaise (PEM), or Dysautonomia.
Participants' interactions with study staff and the study visits will occur primarily via REDCap and Zoom. Informed consent will be conducted remotely via Zoom and obtained electronically in REDCap. Subjects will complete protocol-required logs, questionnaires, and surveys in REDCap. Dose tolerability assessments will occur via televisit preferably, or phone if necessary.
Following informed consent, subjects will enter a 4-week screening period during which medical records will be obtained and reviewed. At baseline (Day -28) subjects will complete a battery of tests consisting of the World Health Organization Disability Assessment Schedule (WHODAS) 2.0, Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a, Insomnia Severity Scale, PROMIS Cognitive Function 6A, DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM) Short Form, Headache Diary, COMPASS 31, and Self-reported persistent symptoms questionnaire. The headache diary requires daily tracking for 7 days (i.e., Day -28- Day -22).
Subjects who complete the screening phase will proceed to randomization where they will be randomized 2:1 to either histamine receptor antagonists (cetirizine and famotidine) or matching placebos. Emory University's Investigational Drug Services (IDS) will conduct the randomization and will overnight via national courier the assigned medication to the study subject. The treatment phase of 12 weeks starts upon ingestion of the first dose.
Cetirizine and famotidine will be supplied as 10mg capsules and 20mg capsules respectively. Dosing for the entire treatment period is one 10mg capsule cetirizine or placebo once daily, preferably at bedtime, and one 20mg capsule famotidine or placebo twice daily, as near as possible to the same time every day. Dose tolerability will be assessed on Day 14 via televisit or phone call. If the dose of either IP is not tolerated, subjects will be removed from the study. If the doses are tolerated, subjects will be resupplied and tolerability assessed per protocol.
Throughout the treatment phase subjects in all arms will complete the symptom questionnaire, adverse event, study drug adherence, and concomitant medication logs weekly. All subjects will complete the full battery of tests on Days 42, 63, and 84 (Weeks 6, 9, and 12). Subjects will have a +/- 3-day window in which to complete the battery. However, the headache diary requires daily tracking for the 7 days preceding Days 43, 63, and 84. On Day 84 all subjects will complete an end-of-study survey assessing their thoughts and feelings about the study methods and procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRA Treatment Arm | Experimental | Drug: Cetirizine, Drug: FamotidineParticipants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. |
| Placebo Arm | Placebo comparator | Drug: Cetirizine Placebo, Drug: Famotidine PlaceboThe compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults ≥18 years of age with a history of a SARS-CoV-2 PCR positive test and/or medical records from a healthcare provider that coincides with the diagnosis of long-COVID
- New or worsened symptoms since the onset of COVID-19 that are persistent at the time of enrollment and have lasted for ≥ 12 weeks (including at least one of the following: fatigue, post-exertional malaise (PEM), headache, brain fog, sleep disturbance, dysautonomia.
- Confirmation of negative urine or serum human chorionic gonadotropin (HCG) (pregnancy) test in women of childbearing potential
- Willing to use appropriate contraceptives for female and male subjects for the duration of the study
- Has an address (for mailing of study drug) in the state of Georgia
Key exclusion criteria (14 listed)
- No post-acute COVID-19 symptoms (PASC) symptoms at the time of enrollment or PASC symptoms present <12 weeks at the time of enrollment
- Inability to provide own informed consent
- Currently Hospitalized
- For women of childbearing potential (WOCBP), currently pregnant or plans to become pregnant during the study period; for males with partners of childbearing potential (OCBP), plans to become pregnant during the study period
- Actively enrolled in another Long COVID/PASC interventional trial or participation in another interventional clinical trial in the last 30 days or planned during the trial period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetirizineCetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. | Drug | HRA Treatment Arm |
| FamotidineAlso: HRAFamotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible. | Drug | HRA Treatment Arm |
| Cetirizine PlaceboThe cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. | Drug | Placebo Arm |
| Famotidine PlaceboThe famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine. | Drug | Placebo Arm |
Primary outcome
Number of Participants That Had Any Confusion Over How to Take the Study Drug, Including Which Pill to Take, When to Take it, or How Many to Take
Time frame: End of the Treatment Phase at 12 weeks
The number of participants that had any confusion over how to take the study drug, including which pill to take, when to take it, or how many to take will be recorded as part of the end-of-study survey.
Number of Participants That Had Trouble Adhering to the Study Drug Schedule
Time frame: End of the Treatment Phase at 12 weeks
The number of participants that had trouble adhering to the study drug schedule will be recorded as part of the end-of-study survey.
Number of Participants That Had Any Difficulty Using the REDCap Interface.
Time frame: End of the Treatment Phase at 12 weeks
The number of participants that had any difficulty using the REDCap interface will be recorded as part of the end-of-study survey.
Number of Participants That Prefer Participating in This Virtual Study
Time frame: End of the Treatment Phase at 12 weeks
The number of participants that prefer participating in this virtual study compared to participating in an in-person study hosted at a medical center will be recorded as part of the end-of-study survey.
Number of Participants Satisfied With Their Opportunities to Interact With Study Staff
Time frame: End of the Treatment Phase at 12 weeks
The number of participants satisfied with their opportunities to interact with study staff will be recorded as part of the end-of-study survey.
Number of Participants That Felt They Could Reach Study Staff if Needed
Time frame: End of the Treatment Phase at 12 weeks
The number of participants that felt they could reach study staff if needed will be recorded as part of the end-of-study survey.
Number of Participants That Felt That Study Staff Was Available and Easy to Contact to Report Any Adverse Effects
Time frame: End of the Treatment Phase at 12 weeks
The number of participants that felt that study staff was available and easy to contact to report any adverse effects that they experienced from the medication will be recorded as part of the end-of-study survey.
Number of Participants That Felt That the Amount of Information Collected in Each Series of Surveys Was Acceptable
Time frame: End of the Treatment Phase at 12 weeks
The number of participants that felt that the amount of information collected in each series of surveys was acceptable will be recorded as part of the end-of-study survey.
Number of Participants That Felt That the Frequency in Which the Information Was Collected Was Acceptable
Time frame: End of the Treatment Phase at 12 weeks
The number of participants that felt that the frequency in which the information was collected was acceptable will be recorded as part of the end-of-study survey.
Improvement Rating
Time frame: End of the Treatment Phase at 12 weeks
Participants will be asked how much they feel they improved from this treatment over the last 12 week using a scale from 1 to 5, with 5 being complete improvement (better outcome) and 1 being no improvement.
Quality of Life (QoL) Score Rating
Time frame: End of the Treatment Phase at 12 weeks
Participants will be asked how much their quality of life was impacted by changes to their health during the study. On a scale of 1 to 5 with 5 being the most impacted (better outcome) and 1 being not at all impacted by changes to their health.
Interest Score
Time frame: End of the Treatment Phase at 12 weeks
Participants will be asked how interested they are in continuing treatment with the study medication after the study. On a scale of 1 to 5, with 5 being completely interested (better outcome) and 1 being completely uninterested.
8 secondary outcomes
Proportion of Survey Completion
Time frame: End of the Treatment Phase at 12 weeks
Proportion of Study Drug Adherence
Time frame: End of the Treatment Phase at 12 weeks
Proportion of Lost to Follow Up (LFUP)
Time frame: End of the Treatment Phase at 12 weeks
Proportion of Voluntary Termination
Time frame: End of the Treatment Phase at 12 weeks
Adverse Events (AEs) Incidence
Time frame: End of the Treatment Phase at 12 weeks
Serious, Unexpected Suspected Adverse Reactions (SUSAR) Incidence
Time frame: End of the Treatment Phase at 12 weeks
Study-wide Serious Adverse Events (SAEs) Incidence
Time frame: End of the Treatment Phase at 12 weeks
Number of Discontinuations or Temporary Suspensions of IP
Time frame: End of the Treatment Phase at 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified datasets may be available to external researchers following final analyses. Requests will be evaluated on a case-by-case basis by PI. No data will be released without proof of Institutional Review Board (IRB) approval or determination. Agreements as required by local policies will be completed when necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Walker, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetirizine and Famotidine in people with COVID-19, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Had Any Confusion Over How to Take the Study Drug, Including Which Pill to Take, When to Take it, or How Many to Take (time frame: End of the Treatment Phase at 12 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.