Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia
Condition: SARS-CoV-2 Infection; Fibrosis Lung
MeSH terms: COVID-19; Pneumonia; Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The innovative drug Treamid is planned for use in the rehabilitation of patients after
      COVID-19 pneumonia in a pilot, multicenter, randomized, double-blind, placebo-controlled
      Phase II clinical study to assess the efficacy and safety of Treamid, tablets, 50 mg in
      patients with fibrotic changes in the lungs after COVID-19 pneumonia during a 28-day
      treatment.

      The primary objective of the study is to demonstrate the efficacy of Treamid tablet, 50 mg in
      change in forced vital capacity (FVC) and/or diffusing capacity of lung for carbon monoxide
      (DLCO) at Week 4.

      The secondary objective of the study is to evaluate the safety of Treamid tablet, 50 mg and
      pharmacokinetics (PK).
    

Detailed description: 
      12-15 Russian centers are planned for participation in this pilot study. The study consists
      of three periods: screening (2 weeks), treatment period (4 weeks) and follow-up period (2
      weeks after completion of treatment with Treamid / Placebo). The duration of participation in
      the study for each patient is no more than 8 weeks.

      60 patients with fibrotic changes in the lungs after COVID-19 pneumonia are planned to be
      randomized. All patients will undergo a qualitative determination of coronavirus severe acute
      respiratory syndrome coronavirus 2 (SARS-CoV-2) by polymerase chain reaction (PCR). Patients
      will be evaluated using the Modified British Medical Research Council (mMRC) Dyspnea Scale,
      chest computed tomography (CT), spirometry and body plethysmography with determination of
      DLCO. This examination should be conducted as close as possible to the expected randomization
      date (no earlier than 5 days before). All eligible patients will be randomized into 2 groups
      in a 1:1 ratio: Treamid 50 mg daily (30 patients); Placebo (30 patients).

      During the treatment period (4 weeks), patients will receive 1 tablet Treamid / Placebo once
      a day. Patients will be advised to continue the standard program of medical rehabilitation
      under day inpatient or outpatient conditions (stage 3 according to the Interim Guidelines for
      Medical Rehabilitation after New Coronavirus Infection (COVID-19), 2020.

      Patients will visit the study center once a week. At the Week 1, Week 2 and Week 3 visits,
      Adverse events (AEs) and concomitant therapy, investigational drug registration, body weight,
      vital signs and Oxygen saturation (SpO2) scores, mMRC dyspnea score and spirometry will be
      recorded.

      During the Week 2 visit, physical examination, electrocardiography (ECG), complete blood
      count (CBC) and biochemical blood test, PK study, common urine analysis, bodyplethysmography
      with DLCO will also be conducted. Patients will complete the KBILD questionnaire. Also, the
      patients will undergo a 6-minute walk test to measure the distance the patient walks for 6
      minutes and evaluate using the Borg Scale. At the Week 4 visit (the end of the therapy),
      registration of AEs and concomitant therapy, physical examination, measurement of height,
      body weight, vital signs and SpO2, ECG, CBC and biochemical blood tests, PK study and common
      urine analysis will be conducted. Patients will be evaluated using the mMRC Dyspnea Scale,
      chest CT, spirometry and body plethysmography with determination of DLCO. Patients will
      complete the King's Brief Interstitial Lung Disease Questionnaire (KBILD) followed by a
      6-minute walk test to measure the distance the patient walks for 6 minutes and evaluate using
      the Borg Scale.

      Patient follow-up will continue for another 2 weeks. At the Week 6 visit, registration of AEs
      and concomitant therapy, physical examination, measurement of height, body weight, vital
      signs and SpO2, ECG, mMRC dyspnea score, CBC and biochemical blood tests, and common urine
      analysis will be conducted.
    

Intervention name(s): Treamid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive Treamid 50 mg once a day during 4 weeks; Participants will receive Placebo once a day during 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COVID-19; Coronavirus; Rehabilitation