Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial

NCT05946551 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: STUDY00005537
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

Brief 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 (PCR) positive test and/or medical records from a healthcare provider that coincides with the diagnosis of long-COVID.

Conditions

COVID-19

Keywords

Long COVID-19

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  End of the Treatment Phase at 12 weeks

Secondary Outcomes (8)

• Proportion of Survey Completion

  End of the Treatment Phase at 12 weeks

• Proportion of Study Drug Adherence

  End of the Treatment Phase at 12 weeks

• Proportion of Lost to Follow Up (LFUP)

  End of the Treatment Phase at 12 weeks

• Proportion of Voluntary Termination

  End of the Treatment Phase at 12 weeks

• Adverse Events (AEs) Incidence

  End of the Treatment Phase at 12 weeks

Study Arms (2)

HRA Treatment Arm

EXPERIMENTAL

Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily.

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.

Drug: Cetirizine Placebo; Drug: Famotidine Placebo

Interventions

Cetirizine DRUG

Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime.

HRA Treatment Arm

Famotidine DRUG

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.

Also known as: HRA

HRA Treatment Arm

Cetirizine Placebo DRUG

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.

Placebo Arm

Famotidine Placebo DRUG

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.

Placebo Arm

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Emory University: lead
• CURE Drug Repurposing Collaboratory (CDRC): collaborator

Study Sites (4)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

Metro-Atlanta

Atlanta, Georgia, 30340, United States

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

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; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Tiffany Walker, MD Assistant Professor
• Organization: Emory University

tiffany.austin.walker@emory.edu

404-778-1621

Study Officials

• Tiffany Walker, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 14, 2023
• Study Start: March 8, 2024
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Datasets may be available following final analyses and publication.
• Access Criteria: Proposals should be directed to tiffany.austin.walker@emory.edu.

Locations

US (4)