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

Summary

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.

Conditions

• Chronic Fatigue Syndrome
• COVID-19, Long Haul

Interventions

DRUG

Pregabalin

Pregabalin pharmacotherapy

BEHAVIORAL

Independent walking training

Independent walking training

DRUG

Placebo

Placebo

BEHAVIORAL

Gradual movement therapy in the ward

Gradual movement therapy in the ward

BEHAVIORAL

Telerehabilitation

Telerehabilitation

BEHAVIORAL

Psychotherapy

Psychotherapy

Sponsors & Collaborators

• Medical Research Agency, Poland

  collaborator OTHER_GOV

• National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

  lead NETWORK

Principal Investigators

• Beata Tarnacka, Prof, Md, PhD · National Institute of Geriatrics, Rheumatology and Rehabilitation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-24

Primary Completion

2028-03-01

Completion

2028-03-01

Countries

• Poland

Study Locations