Сlinical Trial of Efficacy and Safety of Prospekta in the Treatment of Post-COVID-19 Asthenia.
Condition: Post-acute COVID-19 Syndrome
MeSH terms: COVID-19; Post-Acute COVID-19 Syndrome; Asthenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.

      The objective of this study is to evaluate the efficacy and safety of Prospekta in the
      treatment of asthenia in patients after the coronavirus infectious disease (COVID-19).
    

Detailed description: 
      Design: the multicenter, double-blind, placebo-controlled, parallel-group, randomized
      clinical trial.

      The study will enroll adult patients of either gender aged 18 to 65 years after new
      coronavirus infection of 2019 (COVID-19) with symptoms of asthenia that appeared during or
      after an acute coronavirus infection (COVID-19) and persisting 4 to 12 weeks from the onset
      of coronavirus infection.

      After the patient signs the patient information sheet and the informed consent form for
      participation in the study, complaints, medical history, physical examination, registration
      of vital signs are collected, the patient fills in the Fatigue Severity Scale (FSS) and
      Hospital Anxiety and Depression Scale (HADS). A six-minute walk test (6MWT) is carried out.
      The physician evaluates the severity of asthenia with FSS scale and records concomitant
      medications, co-morbidities and concurrent conditions.

      If a patient meets all inclusion criteria and does not have any of the exclusion criteria at
      Visit 1 (Day 1), he/she is randomized to one of two groups: Group 1 - patients receive
      Prospekta at a dose of 1 tablet twice daily for 4 weeks; Group 2 - patients receive placebo
      on the study drug regimen.

      The trial will use electronic patient diaries (EPD). The patient should record any possible
      deterioration (if applicable) in the EPD. At Visit 1 (Day 1), the physician will provide
      guidance on how to work with EPD, so that the patient can use it independently in the future.

      At Visit 2 (Week 4 ± 3 days), the physician will collect patient's complaints, record
      physical examination data and vital signs as well as any changes in concurrent diseases and
      conditions. The patient fills out the FSS and HADS scales. A 6MWT is carried out. The
      physician monitors the prescribed treatment and use of concomitant medications, evaluates the
      safety of the study treatment and patient's compliance, filling out the diary.

      The patient stops taking the study drug. At the end of the study treatment period, the
      patient is monitored for 4 weeks (follow-up period).

      At Visit 3 (final visit, Week 8 ± 3 days), the physician collects patient's complaints,
      records physical examination data and vital signs, changes in concomitant diseases and
      conditions. The patient fills in the FSS and HADS scales. A 6MWT is carried out. The
      physician evaluates the safety of the study treatment, checks the completion of the diary.

      During the study the patients are allowed to take medications for their chronic conditions,
      except for medicines listed as "Prohibited concomitant treatment".
    

Intervention name(s): Prospekta; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration.; Oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind, placebo-controlled, parallel-group, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment