Sonlicromanol in Post-COVID

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMichele van Vugt

About this trial

The aim of this randomized, double-blind, placebo-controlled, phase II trial, is to study the effect of sonlicromanol on fatigue in patients with post-COVID who experience post-exertional malaise (PEM).

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Sonlicromanol
  • Placebo

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Michele van Vugt

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor institution

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator

Khondrion BV

Collaborator