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

NCT05592418 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AMP-518
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Post COVID-19 Condition; Long COVID

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score)

  Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. The lowest possible raw score is 7; the highest possible raw score is 35. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 29.4; the highest possible T-score is 83.2. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. Scores \<55 are within normal limits, 55-60 mild, 61-70 moderate, and \>70 severe fatigue.

  Baseline and Week 13

Secondary Outcomes (6)

• Change From Baseline to Week 6 in PROMIS Fatigue Score (T-Score)

  Baseline to Week 6

• Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score), Excluding Response to Item Seven

  Baseline to Week 6 and 13

• Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT)

  Baseline to week 6 and week 13

• Percentage of Subjects With Minimal Clinically Important Difference (MCID)

  End of 12 week treatment phase

• Change From Baseline to Week 6 and 13 in PROMIS Cognitive Function Converted Score (T-Score).

  Baseline to Week 6 and 13

Other Outcomes (8)

• Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase.

  Baseline and the end of treatment phase at week 12

• Change From Baseline in Cognitive Function as Measured by Montreal Cognitive Assessment (MoCA) at Weeks 4, 8, and 13 During the Treatment Phase

  Baseline to weeks 4, 8 and 13 during treatment phase

• Hospitalizations

  During the treatment phase up to 12 weeks

Study Arms (2)

Ampligen / rintatolimod

EXPERIMENTAL

Subjects will receive rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks.

Drug: Rintatolimod

Placebo / Saline

PLACEBO COMPARATOR

Subjects will receive placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks.

Other: Placebo / Normal Saline

Interventions

Rintatolimod DRUG

100 to 400 mg twice weekly

Also known as: Ampligen, poly I : poly C12U, Rintatolimod (poly I : poly C12U)

Ampligen / rintatolimod

Placebo / Normal Saline OTHER

40 to 160 mL twice weekly

Placebo / Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• AIM ImmunoTech Inc.: lead
• Amarex Clinical Research: collaborator

Study Sites (5)

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

310 Clinical Research

Inglewood, California, 90301, United States

Location

Acclaim Clinical Research

San Diego, California, 92120, United States

Location

Alfa Medical Research

Davie, Florida, 33024, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

poly(I).poly(c12,U); Saline Solution

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Study didn't aim to establish statistical significance of Ampligen® over placebo. Sample size of 80 subjects was based on clinical judgement and no statistical power calculation was used. Fatigue itself, along with cognitive function and sleep, is a multidimensional measure and can be influenced by many factors beyond study treatment, such as general health status, physical activity, etc. Placebo effect is a known challenge, particularly when using patient-reported outcomes as study endpoints.

Results Point of Contact

• Title: Diane Young
• Organization: AIM ImmunoTech Inc.

diane.young@aimimmuno.com

352-448-7797

Study Officials

• David R Strayer, MD

  AIM ImmunoTech Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 24, 2022
• Study Start: June 30, 2023
• Primary Completion: November 17, 2023
• Study Completion: November 30, 2023
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)