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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

Summary

This trial tests if Ampligen®, given through an IV, can help reduce fatigue in patients who still feel tired after recovering from COVID-19 by adjusting their immune response. Ampligen® has been studied for its potential to modulate the immune system and has been investigated in various conditions, including chronic fatigue syndrome.

Eligible Conditions
  • COVID-19
  • Post-COVID Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 6 and 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 6 and 13 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
6-minute walk test
PROMIS® Cognitive Function Score (T-Score)
PROMIS® Fatigue Score (T-Score)
+1 more
Other study objectives
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%
Pleural Effusion
7%
Dehydration
7%
Dyspnoea
7%
Productive cough
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
~34 spots leftby Nov 2025
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