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

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: CURE Drug Repurposing Collaboratory (CDRC)
• Treatments: Cetirizine; Famotidine

Criteria

Inclusion Criteria:

1. 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

2. 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.

3. Confirmation of negative urine or serum human chorionic gonadotropin (HCG) (pregnancy) test in women of childbearing potential

4. Willing to use appropriate contraceptives for female and male subjects for the duration of the study

5. Has an address (for mailing of study drug) in the state of Georgia

6. Able to swallow capsules

7. 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

8. Available lab work (CBC and CMP) after the onset of long COVID symptoms

9. Willing and able to comply with scheduled visits, treatment plan, and other study procedures including receiving either intervention or placebo

10. Willing to not take any of the study medications while enrolled in the study except for essential needs as prescribed by a healthcare provider

Exclusion Criteria:

1. No post-acute COVID-19 symptoms (PASC) symptoms at the time of enrollment or PASC symptoms present <12 weeks at the time of enrollment

2. Inability to provide own informed consent

3. Currently Hospitalized

4. 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

5. 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

6. 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

7. Other medical conditions occurring after the onset of COVID-19 that can otherwise account for PASC-type symptoms

8. Currently immunocompromised from the following: solid organ transplant, bone marrow transplant (BMT), high dose steroids (>20mg prednisone per day), immune modulators, or chemotherapy

9. Currently taking opioid analgesics, undergoing treatment for opioid addiction, or taking any other prohibited concomitant medication

10. Opioid dependence or withdrawal syndrome

11. Known sensitivity or adverse reaction to H1 or H2 receptor antagonists, or medication components

12. Suspected or confirmed pregnancy or breastfeeding

13. Participants already on H1 or H2 receptor antagonists within three (3) months of randomization

14. Currently receiving other therapies to treat COVID-19 or Long COVID symptoms, e.g., convalescent plasma, remdesivir, Paxlovid