NCT05592418Phase 2Completed

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

Study sponsor: AIM ImmunoTech Inc. · AIM

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-11-17Actual

Enrollment · participants80Actual

Source updated2025-01-22Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Post COVID-19 Condition; Long COVID

Treatments or interventions studied

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

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score); description: 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.; timeFrame: Baseline and Week 13

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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