NCT05967052: POSTCOVID

Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation

Recruiting now Phase 2 Last updated 14 November 2023

What this trial tests

Phase 2 trial testing Pregabalin in Chronic Fatigue Syndrome in 132 participants. Currently enrolling.

Timeline

24 October 2023

Primary endpoint
1 March 2028

1 March 2028

Quick facts

Lead sponsor	National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	132
Start date	24 October 2023
Primary completion	1 March 2028
Estimated completion	1 March 2028
Sites	1 location across Poland

Drugs / interventions tested

• Pregabalin (Pregabalin) — full drug profile →
• Independent walking training
• Placebo
• Gradual movement therapy in the ward
• Telerehabilitation
• Psychotherapy

Conditions studied

• Chronic Fatigue Syndrome — all drugs for Chronic Fatigue Syndrome →
• COVID-19, Long Haul — all drugs for COVID-19, Long Haul →

Sponsor

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Who can join

Adults 18 to 65, any sex, with Chronic Fatigue Syndrome or COVID-19, Long Haul. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive rehabilitation phase II clinical trial to determine the usefulness of pregabalin in a new indication (post-COVID chronic fatigue syndrome).

Patients will be randomized in a 1:1:1:1 ratio to pregabalin (75-300 mg daily in two divided doses), comprehensive rehabilitation with a placebo drug, comprehensive rehabilitation with pregabalin (75-300 mg in two divided doses), or placebo (two divided doses) for 6 months (177-187 days).

There will be 4 outpatient visits to the research center and 12 telephone consultations.

The procedures and assessments performed as part of the study are listed in the study schedule.

It is planned to include 132 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 120 patients (30 in each arm).

Patients will be recruited during an outpatient medical consultation with a general practitioner or neurologist, psychiatrist, psychologist or other specialists, as well as with the use of information materials in the form of leaflets and advertisements on the Internet.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.