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.
This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the efficacy and safety of Ampligen® in patients experiencing the Post-COVID Condition of fatigue. Patients will be randomized 1:1 to receive twice weekly IV infusions of Ampligen® or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
100 to 400 mg twice weekly
40 to 160 mL twice weekly
Hope Clinical Research
Canoga Park, California, United States
310 Clinical Research
Inglewood, California, United States
Acclaim Clinical Research
San Diego, California, United States
Alfa Medical Research
Davie, Florida, United States
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.
Time frame: Baseline and Week 13
Change From Baseline to Week 6 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.
Time frame: Baseline to Week 6
Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score), Excluding Response to Item Seven
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. For this endpoint, the last question of "How often did you have enough energy to exercise strenuously" was excluded. Therefore, the lowest possible raw score is 6; the highest possible raw score is 30. 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 33.4; the highest possible T-score is 76.8. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual.
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Zenos Clinical Research
Dallas, Texas, United States
Time frame: Baseline to Week 6 and 13
Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT)
The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance.
Time frame: Baseline to week 6 and week 13
Percentage of Subjects With Minimal Clinically Important Difference (MCID)
Percentage of subjects with increase of at least 54 m from baseline in the Six-Minute Walk Test (6MWT) at the end of 12-week treatment phase presented and summarized descriptively by treatment group.
Time frame: End of 12 week treatment phase
Change From Baseline to Week 6 and 13 in PROMIS Cognitive Function Converted Score (T-Score).
Change in mean cognitive function T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Cognitive Function - Abilities short form 8a that assesses self-perceived cognitive deficits. The lowest possible raw score is 8; the highest possible raw score is 40. 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 23.27; the highest possible T-score is 67.09. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the better the cognitive function of the individual. Scores \>45 are within normal limits, 40-45 mild, 30-40 moderate, and \<30 severe cognitive dysfunction.
Time frame: Baseline to Week 6 and 13
Change From Baseline to Week 6 and 13 in PROMIS Sleep Disturbance Score (T-Score)
Change in mean sleep disturbance T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance - short form 4a that assesses self-perceived sleep quality. The lowest possible raw score is 4; the highest possible raw score is 20. 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 32; the highest possible T-score is 73.3. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the sleep disturbance of the individual. Scores \<55 are within normal limits, 55-60 mild, 61-70 moderate, and \>70 severe fatigue.
Time frame: Baseline to Week 6 and 13