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

Completed · Phase 2 · Has a placebo group

Conditions studied: Post COVID-19 Condition, Long COVID

In brief

The purpose of this study is to assess the efficacy and safety of Ampligen® administered twice weekly by intravenous (IV) infusions in subjects experiencing the Post-COVID Condition of fatigue.

Key facts

Study ID: NCT05592418
Run by: AIM ImmunoTech Inc.
People needed: 80
Starts: 2023-06-30
Expected to finish: 2023-11-30
Last updated by the study team: 2025-01-22

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 <94% on room air at the time of screening.
Thrombocytopenia (platelets <100×109/L), anemia (hemoglobin <9.0 g/dL), or leukopenia (WBC <3×109/L) on screening labs
History of splenectomy.
Known hypercoagulable state or at increased risk of thrombosis (e.g., due to immobility)
Liver cirrhosis or patient showing signs of clinical jaundice at the time of screening.
Transaminase (ALT or AST) >3X ULN or total bilirubin >2X ULN at screening
Chronic kidney disease stage 4 or requiring dialysis at the time of screening.
Estimated GFR <60 mL/min/1.73 m2 at the time of screening
NYHA Class III or IV congestive heart failure (CHF).
Exhibiting signs of uncontrolled hypo-or hyper-thyroidism at the time of Screening.
Diagnosis of autoimmune disease (e.g., SLE, rheumatoid arthritis, psoriasis) at the time of screening
Uncontrolled rheumatologic disorders at the time of screening.
Diagnosis of sleep apnea (central or obstructive) at the time of screening.
History of organ transplantation or are candidates for organ transplantation at the time of screening.
History of Chronic Fatigue Syndrome prior to COVID-19 infection.
History of fibromyalgia prior to COVID-19 infection.
History of major psychiatric disorder including psychotic or melancholic features, bipolar disorders, schizophrenia of any subtype, schizoaffective disorder, major depression delusional disorders of any subtype, dementias of any subtype, anorexia nervosa or bulimia nervosa.
Any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases.
Any other clinically significant serious systemic diseases, chronic or intercurrent active medical disorder and other reasons which would interfere with study conduct or study results interpretation per the Investigator.
Chronic or intercurrent acute medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe per the investigator.
Therapy with interferons, interleukins, or other cytokines or investigational drugs within 6 weeks of beginning study medication. Subjects must give written informed consent prior to discontinuation of investigational drugs.
Treatment with any of the following therapies within the eight (8) weeks immediately preceding the start of study baseline or during baseline: systemic glucocorticoids (i.e., hydrocortisone, prednisone, etc.) or mineralocorticoids (i.e., fludrocortisone (Florinef), etc.), interferons, interleukin-2, systemic antivirals, gamma globulin or investigational drugs or experimental agents not yet approved for use in the United States.

Where it is running

Hope Clinical Research — Canoga Park, California, United States
310 Clinical Research — Inglewood, California, United States
Acclaim Clinical Research — San Diego, California, United States
Alfa Medical Research — Davie, Florida, United States
Zenos Clinical Research — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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