Ampligen in Chronic Fatigue Syndrome

Inclusion Criteria:

1. Diagnosis of Chronic Fatigue Syndrome (>= 12 months) as defined by the 1988 Centersfor Disease Control and Prevention CDC case definition for CFS or as defined only bythe 1994 CDC case definition of CFS (Fukuda et al., Ann Intern Med. 1994; 121:953-959) (other clinical conditions which could present with similar symptomsmust be excluded.).

2. Age Range: >= 18 years old, <= 70 years old.

3. Males or non-pregnant, non-lactating females: Females must be of non-child bearingpotential (either post-menopausal for two years or surgically sterile includingtubal ligation) or using an effective means of contraception (birth control pills,intrauterine device, diaphragm). Alternatively, female patients with a male partnerhaving a successful vasectomy (considered successful if a volunteer reports that amale partner has either documentation of azoospermia by microscopy or a vasectomymore than 2 years ago with no resultant pregnancy despite sexual activitypost-vasectomy).Females who are less than two (2) years post-menopausal, those withtubal ligations and those using contraception must have a negative serum pregnancytest at baseline within the four (4) weeks prior to the first study medicationinfusion. Every four weeks, and at study termination a pregnancy test should beperformed, either serum or urine stick test. However, if the urine result ispositive, a serum pregnancy test will be performed. Females of child bearingpotential agree to use an effective means of contraception from four (4) weeks priorto the baseline pregnancy test until four (4) weeks after the last study medicationinfusion. All male patients agree not to be a sperm donor and to use an effectivemeans of contraception while on study medication and until 90 days after the laststudy medication infusion.

4. A reduced quality of life as determined by a Karnofsky performance score (KPS) of >= 20 and <= 60. The KPS must be rounded in increments of ten (10).

5. Ability to provide written informed consent indicating awareness of theinvestigational nature of this study.

6. Documentation (during baseline or historically following the onset of CFS) of anegative ANA or a negative anti-ds (double-stranded) DNA, a negative RheumatoidFactor, and an erythrocyte sedimentation rate (ESR). Documentation during baselineof a normal T4 (or other laboratory evidence that subject is euthyroid) is alsorequired.

7. Laboratory confirmed negative SARS-CoV-2 (COVID-19) infection by a governmentapproved test / kit within 2 weeks prior to starting study drug dosing.

8. Patients with post-COVID-19 chronic fatigue (PCCF) must meet the 1988 or 1994 CFSCDC Definition for Chronic Fatigue Syndrome except for the duration of the fatiguingillness which must have continued for at least 3 months and must not have precededthe onset of the COVID-19 symptoms. The patient must also have at least one of thefollowing "Long Hauler" symptoms which must have persisted or recurred during 3 ormore consecutive months of illness and must not have preceded the onset of theCOVID-19 symptoms (fever or chills, cough, shortness of breath or difficultybreathing, new loss of taste or smell or chest pain). Since many patients with mildor no COVID-19 symptoms were not tested for the presence of SARS-CoV-2, manypatients with post-COVID-19 chronic fatigue (PCCF) also called "Long Haulers", willnot have a history of a positive SARS-CoV-2 test result. A positive serum antibodytest for SARS-CoV-2 will be sufficient in these cases.

Exclusion Criteria:

1. Inability to return for scheduled treatment and assessments.

2. Chronic or intercurrent acute medical disorder or disease making implementation orinterpretation of the protocol or results difficult or unsafe.

3. Pregnant or lactating females.

4. Therapy with interferons, interleukins, or other cytokines or investigational drugswithin 6 weeks of beginning study medication. Subjects must give written informedconsent prior to discontinuation of investigational drugs.