| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05592418 | Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions | PHASE2 | COMPLETED | 80 | — | — | Jun 30, 2023 | Nov 30, 2023 | Jan 22, 2025 | 5 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Ampligen / rintatolimod | EXPERIMENTAL | Subjects will receive rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. |
| Placebo / Saline | PLACEBO_COMPARATOR | Subjects will receive placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Rintatolimod | DRUG | 100 to 400 mg twice weekly |
| Placebo / Normal Saline | OTHER | 40 to 160 mL twice weekly |
Inclusion Criteria: 1. Male or female adult between 18 to 60 (inclusive) years of age at time of enrollment. 2. 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 fo...