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Immunomodulator

Ampligen / rintatolimod for COVID-19

Phase 2
Waitlist Available
Research Sponsored by AIM ImmunoTech Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the treatment phase
Awards & highlights

Study Summary

This trial will look at how safe and effective a drug called Ampligen is in treating post-COVID fatigue.

Eligible Conditions
  • COVID-19
  • Post-COVID Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and during course of the treatment phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and during course of the treatment phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
6-minute walk test
PROMIS® Cognitive Function Score (T-Score)
PROMIS® Fatigue Score (T-Score)
+1 more
Other outcome measures
COVID-19-related symptoms
Duration of Hospitalizations
Hospitalizations
+3 more

Side effects data

From 2021 Phase 2 trial • 19 Patients • NCT03403634
73%
Fatigue
73%
Chills
40%
Hot flush
33%
Pyrexia
33%
Decreased appetite
27%
Nausea
20%
Gastrointestinal disorders **Any AE - Maximum Grade Seen Diarrhoea
20%
Headache
13%
Blood alkaline phosphatase increased
13%
Weight decreased
13%
Myalgia
13%
Vomiting
7%
Dehydration
7%
Dyspnoea
7%
Productive cough
7%
Pleural Effusion
7%
Insomnia
7%
Dizziness
7%
Hyperbilirubinemia
7%
Neoplasm (NOS)
7%
Death
7%
Asthenia
7%
Influenza like illness
7%
Mucosal infection
7%
Sinus congestion
7%
Hypotension
7%
Hyperhidrosis
7%
Dyspepsia
7%
Platelet count decreased
7%
Musculoskeletal pain
7%
Infusion related reaction
7%
Aspartate aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ampligen / rintatolimodExperimental Treatment1 Intervention
Subjects will receive rintatolimod (intravenous [IV]), up to 400 mg twice weekly for 12 weeks.
Group II: Placebo / SalinePlacebo Group1 Intervention
Subjects will receive placebo / normal saline (intravenous [IV]), up to 160 mL twice weekly for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rintatolimod
2019
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

AIM ImmunoTech Inc.Lead Sponsor
14 Previous Clinical Trials
628 Total Patients Enrolled
Amarex Clinical ResearchOTHER
26 Previous Clinical Trials
1,602 Total Patients Enrolled
5 Trials studying COVID-19
161 Patients Enrolled for COVID-19
David R Strayer, MDStudy DirectorAIM ImmunoTech Inc.
6 Previous Clinical Trials
452 Total Patients Enrolled

Media Library

Rintatolimod (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT05592418 — Phase 2
COVID-19 Research Study Groups: Ampligen / rintatolimod, Placebo / Saline
COVID-19 Clinical Trial 2023: Rintatolimod Highlights & Side Effects. Trial Name: NCT05592418 — Phase 2
Rintatolimod (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05592418 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process open for this medical trial?

"According to the clinicaltrials.gov data, this trial is currently recruiting participants. The study was initially published on June 1st 2023 and recently updated on 28th of that same month."

Answered by AI

Does this research require participants to be of a certain age or can any adult join?

"This trial is restricted to patients between 18 and 60 years of age. Meanwhile, 318 other trials are available for minors, while 1048 clinical studies exist that cater to those over the age of 65."

Answered by AI

Has the FDA issued a permit for Ampligen / rintatolimod?

"Ampligen / rintatolimod received a score of 2 on our internal safety scale since there is only limited evidence to suggest its efficacy and some data indicating that it may be safe."

Answered by AI

Who has the aptitude to participate in this clinical study?

"This clinical trial is seeking 80 participants, aged 18-60 years old, who have had a previously confirmed positive COVID-19 diagnosis at least 12 weeks earlier. Additionally, individuals must display evidence of fatigue per the 1994 CDC Case Definition for Chronic fatigue syndrome (CFS), score ≥12 on PROMIS® Fatigue- Short Form 4a test and receive an Electrocardiogram with no clinically significant findings as assessed by the Investigator. Those presenting symptoms of coronary insufficiency or any other type of cardiac event may not be eligible to participate in this study."

Answered by AI

How many participants are eligible for inclusion in this trial?

"Affirmative, the information on clinicaltrials.gov attests that this investigation is actively looking for participants. This endeavour was first published on June 1st 2023 and its last update occurred in late June of the same year. It requires 80 individuals to be recruited across two sites."

Answered by AI
~46 spots leftby Apr 2025