Ampligen in Chronic Fatigue Syndrome

Inclusion Criteria:

1. Diagnosis of Chronic Fatigue Syndrome (>= 12 months) as defined by the 1988 Centers
for Disease Control and Prevention CDC case definition for CFS or as defined only by
the 1994 CDC case definition of CFS (Fukuda et al., Ann Intern Med. 1994;
121:953-959) (other clinical conditions which could present with similar symptoms
must 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 bearing
potential (either post-menopausal for two years or surgically sterile including
tubal ligation) or using an effective means of contraception (birth control pills,
intrauterine device, diaphragm). Alternatively, female patients with a male partner
having a successful vasectomy (considered successful if a volunteer reports that a
male partner has either documentation of azoospermia by microscopy or a vasectomy
more than 2 years ago with no resultant pregnancy despite sexual activity
post-vasectomy).Females who are less than two (2) years post-menopausal, those with
tubal ligations and those using contraception must have a negative serum pregnancy
test at baseline within the four (4) weeks prior to the first study medication
infusion. Every four weeks, and at study termination a pregnancy test should be
performed, either serum or urine stick test. However, if the urine result is
positive, a serum pregnancy test will be performed. Females of child bearing
potential agree to use an effective means of contraception from four (4) weeks prior
to the baseline pregnancy test until four (4) weeks after the last study medication
infusion. All male patients agree not to be a sperm donor and to use an effective
means of contraception while on study medication and until 90 days after the last
study 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 the
investigational nature of this study.

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

7. Laboratory confirmed negative SARS-CoV-2 (COVID-19) infection by a government
approved 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 CFS
CDC Definition for Chronic Fatigue Syndrome except for the duration of the fatiguing
illness which must have continued for at least 3 months and must not have preceded
the onset of the COVID-19 symptoms. The patient must also have at least one of the
following "Long Hauler" symptoms which 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 (fever or chills, cough, shortness of breath or difficulty
breathing, new loss of taste or smell or chest pain). Since many patients with mild
or no COVID-19 symptoms were not tested for the presence of SARS-CoV-2, many
patients with post-COVID-19 chronic fatigue (PCCF) also called "Long Haulers", will
not have a history of a positive SARS-CoV-2 test result. A positive serum antibody
test 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 or
interpretation of the protocol or results difficult or unsafe.

3. Pregnant or lactating females.

4. 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.