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Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions

NCT05592418 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-01-22

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Rintatolimod

100 to 400 mg twice weekly

OTHER

Placebo / Normal Saline

40 to 160 mL twice weekly

Sponsors & Collaborators

Principal Investigators

  • David R Strayer, MD · AIM ImmunoTech Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2023-11-17
Completion
2023-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05592418 on ClinicalTrials.gov