COVID-19

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About the EPIC Study

The EPIC study is a clinical trial to test a potential nasal spray COVID-19 treatment.

EPIC (Efficacy and Safety of T-COVID in the Prevention of Clinical Worsening in COVID-19) is a Phase 1/2 clinical trial studying the effectiveness and safety of an investigational COVID-19 treatment, called T-COVIDTM. This treatment potentially prevents the progression of COVID-19 and the need for hospitalization in those with early symptoms. T-COVID is being studied as a single dose therapeutic that is delivered via a nasal spray, not an injection. This trial is for outpatients (not in the hospital) showing early symptoms of COVID-19.

EPIC is being sponsored by Altimmune – a publicly-traded, clinical-stage biopharmaceutical company focused on developing intranasal vaccines, immune-modulating therapies, and treatments for liver disease.

                                       

What to Expect Upon Arrival

  1. Verification of a positive COVID-19 test (if you have not received a positive test result, a rapid COVID-19 test will be administered at the study site)

  2. Signing of the consent form to confirm willingness to participate

  3. Determination of your eligibility 

  4. Administering of 1 nasal spray dose (you will only need to visit the study site once for screening and the single dose)

  5. Receipt of a tablet with easy-to-use health measurement tools allowing participants to stay at home for the duration of the study, enabling real time data collection

  6. You can head home! Real-time data will be collected for up to approximately 4 weeks (28 days)

  • 18 years of age and older

  • One or more of the following symptoms within the last 72 hours: Fever greater than or equal to 100.4⁰F, cough, and/or shortness of breath. 

  • Positive COVID-19 test.

  • Able and willing to provide informed consent.

Enrolling in the Study

Participation Criteria

​To enroll in the Epic Clinical Study, please call or visit the Study Site center nearest you to discuss your potential eligibility. We appreciate your interest in participating.

Exclusion Criteria

Individuals with the following conditions or symptoms are not eligible.

  • Pregnant, lactating, or plan to conceive a child during the next 3 months

  • Chronic pulmonary disease, including chronic obstructive pulmonary disease and asthma, or other respiratory diseases that could exacerbate independent of COVID-19

  • Severe obesity (defined as body mass index ≥ 40 kg/m2)

  • History of:

    • Severe cardiovascular disease, including but not limited to congestive heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, or pulmonary hypertension

    • Diabetes mellitus

    • Chronic or current vaping or cigarette smoking

    • Chronic kidney disease requiring dialysis

    • Chronic liver disease, including but not limited to chronic viral hepatitis, non-alcoholic steatohepatitis, or cirrhosis of any cause

    • Hemoglobin disorder, including sickle cell disease and thalassemia

    • Bell’s Palsy

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