Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions

Inclusion Criteria

• Male or female adult between 18 to 60 (inclusive) years of age at time of enrollment.
• Prior confirmed COVID-19 diagnosis by standard RT-PCR assay or equivalent testing at least 12 weeks prior to baseline.

Note: For subjects with COVID-19 symptoms who were not tested for the presence of SARS-CoV-2, a positive serum antibody test for SARS-CoV-2 will be sufficient in subjects not vaccinated for COVID-19 or it can be shown that the positive antibody cannot be associated with the COVID-19 vaccination.

• Laboratory confirmed negative SARS-CoV-2 (COVID-19) infection by a government approved test / kit at time of enrollment.
• Subject meets the criteria of fatigue per the 1994 CDC Case Definition for Chronic Fatigue Syndrome (CFS): Unexplained persistent or relapsing chronic fatigue that is of new or definite onset (i.e., not lifelong), is not the result of ongoing exertion, is not substantially alleviated by rest, and results in substantial reduction in previous levels of occupational, educational, social, or personal activities. The fatigue must have persisted or recurred during 3 or more consecutive months of illness and must not have preceded the onset of the COVID-19 symptoms.
• PROMIS® Fatigue- Short Form 7a score of ≥21 at screening and baseline.
• Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.

Note: Below are the examples of clinically significant ECG abnormalities:

• Previous documented evidence of myocardial infarction or recent significant change in the resting EKG suggesting infarction or other acute cardiac events.
• Current symptoms of coronary insufficiency (i.e. - angina pectoris and/or ST segment depression on EKG).
• Evidence of uncontrolled atrial or frequent or complex ventricular ectopy, or myocardial conduction defect which would increase the risk of syncope (for example, second degree or higher A-V block).
• Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
• Men and women of childbearing potential and their partner must agree to use two medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or one of the following methods of birth control (intrauterine devices, bilateral tubal occlusion, or vasectomy) or must practice complete sexual abstinence for the duration of the study (excluding women who are not of childbearing potential and men who have been sterilized).
• Females of child-bearing potential must have a negative urine pregnancy test at Screening Visit and prior to receiving the first dose of study drug; and Male participants must agree to use contraception and refrain from donating sperm for at least 90 days after the last dose of study intervention.
• Subject is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures and study restrictions.

Exclusion Criteria

• Inability to provide informed consent or to return to the Investigator's site for scheduled infusions and evaluations.
• Exhibiting signs of moderate or severe pulmonary disease (such as COPD, asthma, or pulmonary fibrosis).
• Ongoing requirement of oxygen therapy.
• Pulse oxygen saturation (SpO2) of 3X ULN or total bilirubin >2X ULN at screening
• Chronic kidney disease stage 4 or requiring dialysis at the time of screening.
• Estimated GFR 115 mm Hg or resting systolic blood pressure > 200 mm Hg.
• Uncontrolled metabolic disease (e.g., diabetes, thyrotoxicosis, or myxedema).
• Concurrent use of any beta blockers and/or bronchodilators which cannot remain at a stable dosage level during baseline and the study.
• History of alcohol or other substance abuse within two (2) years before the onset of acu