A Study to Evaluate Ampion in Patients With Prolonged Respiratory Symptoms Due to COVID-19 (Long COVID)
Condition: Covid19
MeSH terms: COVID-19; Post-Acute COVID-19 Syndrome; Signs and Symptoms, Respiratory
Intervention: Ampion; Placebo
Intervention description: Inhaled Ampion; Inhaled Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase I study to evaluate the safety and efficacy of inhaled Ampion on patients
      with prolonged respiratory symptoms due to COVID-19 (Long COVID).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female adults: ≥ 18 years.

          2. Must have a clinical diagnosis of COVID-19 at least 4 weeks prior to the screening
             date, with at least one of clinical symptoms (e.g., fever ≥ 38°C, fatigue, cough) and
             a positive result by the reverse-transcription polymerase chain reaction (RT-PCR)
             testing or equivalent.

          3. Experiencing at least two COVID-19 respiratory symptoms with a score of two or higher
             using the FDA Assessment of 14 Common COVID-19-Related Symptoms questionnaire for at
             least 4 weeks (28 days) after initial positive COVID-19 diagnosis: cough, sore throat,
             runny/stuffy nose, shortness of breath (difficulties breathing), tightness of chest,
             low exercise tolerance.

          4. Able to bear weight and ambulate a minimum of 10 meters distance.

          5. Women of childbearing potential and their partner must agree to use at least one
             highly effective method of contraception (e.g., hormonal contraceptives [implants,
             injectables, combination oral contraceptives, transdermal patches, or contraceptive
             rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the
             duration of the study.

          6. Informed consent obtained from the patient or the patient's legal representative.

        Exclusion Criteria:

          1. Subjects who require hospitalization.

          2. Patient has severe chronic obstructive or restrictive pulmonary disease (COPD) as
             defined by prior pulmonary function tests, chronic renal failure, or significant liver
             abnormality (e.g., cirrhosis, transplant, etc.).

          3. History of Chronic Fatigue Syndrome prior to COVID-19 infection.

          4. Patient is on chronic immunosuppressive medication.

          5. Patient requires surgery that could be life-threatening within the study window.

          6. A history of allergic reactions to human albumin (reaction to non-human albumin such
             as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin
             (N-acetyl tryptophan, sodium caprylate).

          7. Patient has known pregnancy or is currently breastfeeding.

          8. Participation in a trial such that enrollment in this study would fall within the time
             frame of the half-life of the other investigational product(s).

          9. Clinically significant findings via electrocardiogram (ECG), including acute
             myocardial infarction, acute ischemic changes, atrial fibrillation, atrial flutter,
             paced rhythms in individuals who have undergone permanent pacemaker placement,
             evidence of prior infarction, unchanged stable conduction abnormalities e.g., right
             bundle branch block, or any other finding which does not significantly impact
             mortality.

         10. Pre-existing co-morbid condition(s) preventing outcome assessments, e.g. disease or
             condition that would prevent ability to transfer and walk for 6 minutes, prior to
             confirmed COVID-19 diagnosis (assisted walking devices are acceptable)

         11. As a result of the medical review and screening investigation, the Principal
             Investigator considers the patient unfit for the study.