Phase 2: testing Sonlicromanol for Post COVID Condition
The aim of this randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, phase II trial, is to study the effect of sonlicromanol on fatigue in patients with post-COVID who experience post-exertional malaise (PEM).
Official registry: https://clinicaltrials.gov/study/NCT07298005 · Michele van Vugt · enrollment listed as 80
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Sonlicromanol, or Placebo. The registry lists allocation as randomized. The aim of this randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, phase II trial, is to study the effect of sonlicromanol on fatigue in patients with post-COVID who experience post-exertional malaise (PEM).
They plan to enroll about 80 people at Amsterdam. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
SON4PEM Study: Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial
Interventions: Sonlicromanol, Placebo
Primary outcome (registry wording): Fatigue
Who it is for (from inclusion criteria)
- Ages 18 Years to 65 Years
- Post COVID according to WHO criteria and verified by post COVID physician
- Post-exertional malaise (PEM) according to DSQ-PEM questionnaire
- Bell's disability score 20-70%
- Mild initial SARS-CoV-2 infection (no hospitalisation)
- WHO performance score of 0 before initial SARS-CoV-2 infection
Who the registry excludes
- Patients at risk for cardiac conduction disorders
- History of clinical significant gastro-intestinal surgery or dysmotility that impairs the adsorption of the IMP
- Clinically significant respiratory or cardiovascular disease
- Unstable neurological disease
- Clinically significant active psychiatric disorder that requires treatment
- History of substance abuse
- Active malignancy within the past 5 years
Contact
No central phone on the registry card. Use the official listing to reach a site.
Sites listed on ClinicalTrials.gov
1 listed- Amsterdam University Medical Center, Location Academic Medical Center (AMC) — Amsterdam, North Holland, Netherlands (recruiting)
FAQ about this NCT record
Is NCT07298005 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07298005?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07298005?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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