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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT05946551

Run by

Emory University

People needed

5

Starts

2024-03-08

Expected to finish

2024-06-24

Last updated by the study team

2025-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Grady Health System — Atlanta, Georgia, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Emory Hospital — Atlanta, Georgia, United States
• Metro-Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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