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NCT05592418 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions
A Phase 2 study, sponsored by AIM ImmunoTech.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT05592418: Completed Phase 2 study, sponsored by AIM ImmunoTech.
NCT05592418 is a Phase 2 study that has completed, run by AIM ImmunoTech. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05592418, a Phase 2 study, has completed, sponsored by AIM ImmunoTech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Rintatolimod
- OTHER Placebo / Normal Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2023-06-30 |
| Est. Completion | 2023-11-30 |
| Phase | Phase 2 |
What the finished NCT05592418 record still lists
NCT05592418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Rintatolimod is the first listed.
NCT05592418 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05592418 about?
NCT05592418 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions". 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.
What is the current status of trial NCT05592418?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2023-06-30. Estimated completion is 2023-11-30.
What interventions are being tested in trial NCT05592418?
The interventions under investigation include: Rintatolimod (DRUG), Placebo / Normal Saline (OTHER).
Who is sponsoring clinical trial NCT05592418?
This trial is sponsored by AIM ImmunoTech, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05592418's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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