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Rintatolimod

Phase 2

Post COVID-19 Condition | Small molecule | Infectious Disease |AIM ImmunoTech Inc.|Last Updated: Feb 12, 2026

Target and mechanism

Molecular targetTLR3
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL2107862

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Rintatolimod · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT05592418Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID ConditionsPost COVID-19 Condition
COMPLETED80 Analytics
PHASE2COMPLETED
Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions
Post COVID-19 Condition
NCT0559241880
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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.

Objective Response Rate (ORR)
At 13 weeks

The proportion of subjects with the best response of complete response (CR), or partial response (PR) per Response Evaluation Criteria for Solid Tumors (RECIST 1.1). Per RECIST 1.1 , CR is defined as all target lesions gone; PR is defined as a \> 30% decrease in size of lesion from baseline.

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.
cisplatin + rintatolimod + pembrolizumabEXPERIMENTALIntraperitoneal (IP) cisplatin 50mg/m\^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution.

Interventions

NameTypeDescription
RintatolimodDRUG100 to 400 mg twice weekly
Placebo / Normal SalineOTHER40 to 160 mL twice weekly
PembrolizumabDRUG200 mg will be administered as a 30 minute IV infusion
CisplatinDRUG50mg/m\^2 solution
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about Rintatolimod

What is Rintatolimod used for?

Rintatolimod is an investigational small molecule being studied for recurrent ovarian cancer and post COVID-19 condition, also known as long COVID. It is being developed by AIM ImmunoTech Inc. (AIM) and is currently in clinical trials, including a Phase 1 study for recurrent ovarian cancer and a Phase 2 study for post COVID-19 condition.

What does Rintatolimod target?

Rintatolimod is a small molecule that works as a toll-like receptor 3 (TLR3) agonist. It is designed to stimulate the immune system by activating TLR3, which is involved in the body's antiviral and antitumor responses. This mechanism is being investigated for its potential in treating recurrent ovarian cancer and post COVID-19 condition.

Who makes Rintatolimod?

Rintatolimod is developed by AIM ImmunoTech Inc., a biopharmaceutical company traded under the ticker symbol AIM. The company is conducting clinical trials to evaluate the drug's safety and efficacy in recurrent ovarian cancer and post COVID-19 condition.

What phase is Rintatolimod in?

Rintatolimod is in clinical development. It is being studied in a Phase 1 trial for recurrent ovarian cancer and a Phase 2 trial for post COVID-19 condition. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is Rintatolimod in?

Rintatolimod is being evaluated in two clinical trials. NCT03734692 is a Phase 1 study of systemic immune checkpoint blockade and intraperitoneal chemo-immunotherapy in recurrent ovarian cancer, with 24 participants. NCT05592418 is a Phase 2 study of Ampligen in patients with post COVID-19 conditions, with 80 participants. Both trials are based in the United States.

Is Rintatolimod the same as Ampligen?

Yes, Rintatolimod is also known as Ampligen. In clinical trials, the drug is referred to by both names. For example, NCT05592418, a Phase 2 study for post COVID-19 condition, is titled 'Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions,' and it evaluates Rintatolimod.