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Ampligen / rintatolimod for COVID-19
Study Summary
This trial will look at how safe and effective a drug called Ampligen is in treating post-COVID fatigue.
- COVID-19
- Post-COVID Syndrome
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 19 Patients • NCT03403634Trial Design
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Who is running the clinical trial?
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- Group 1: Ampligen / rintatolimod
- Group 2: Placebo / Saline
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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