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Rintatolimod

Phase 2

Post COVID-19 Condition | Small molecule | Infectious Disease |AIM ImmunoTech Inc.|Last Updated: Jan 22, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05592418Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID ConditionsPHASE2 COMPLETED 80Jun 30, 2023Nov 30, 2023Jan 22, 20255 United States
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Study Endpoints
Primary Endpoints
Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score)
Baseline and Week 13

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.

Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ampligen / rintatolimodEXPERIMENTALSubjects will receive rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks.
Placebo / SalinePLACEBO_COMPARATORSubjects will receive placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks.
Interventions
NameTypeDescription
RintatolimodDRUG100 to 400 mg twice weekly
Placebo / Normal SalineOTHER40 to 160 mL twice weekly
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites5

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...

Countries:United States
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