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The innovative drug Treamid is planned for use in the treatment of patients with persistent lung damage and reduced exercise tolerance exertion after COVID-19 pneumonia in a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III clinical study to assess the efficacy and safety of Treamid during a 28-day treatment.
The primary objective of the study is to prove that in the Treamid group, the proportion of patients achieving clinically significant load tolerance is statistically significantly higher than in the placebo group.
The secondary objective of the study is to evaluate the safety of Treamid and achievement of clinically significant improvements in indicators for various questionnaires and spirometry data.
Full description
14-18 Russian centers are planned for participation in this study. The study consists of three periods: screening (2 weeks), treatment period (4 weeks) and follow-up period (4 weeks after completion of treatment with Treamid / Placebo).
412 patients with persistent lung damage and reduced exercise tolerance exertion after COVID-19 pneumonia are planned to be randomized.
Patients will be evaluated using the Modified British Medical Research Council (mMRC), six-minute walk test (6-MWT), Borg scale for dyspnea and fatigue, Dyspnea scale Index (BDI and TDI), KBILD questionnaire, EQ-5D-3L questionnaire, Hospital Anxiety and Depression Scale (HADS), Modified Fatigue Impact Scale (MFIS), Clinical Global Impression rating scales (CGI-I and CGI-S), chest computed tomography (CT), spirometry and body plethysmography with determination of DLCO.
All eligible patients will be randomized into 4 groups of 103 patients each in a 1:1:1:1 ratio: Treamid 25 mg in the morning and Placebo in the evening daily, Treamid 25 mg in the morning and Treamid 25 mg in the evening daily, Treamid 50 mg in the morning and Placebo in the evening daily, Placebo in the morning and Placebo in the evening daily. Patients will visit the study center at the Week 1, Week 2, Week 4 of treatment period and at the end of the follow up period. During all visits will be evaluated Adverse events (AEs), concomitant therapy, investigational drug registration, body weight, vital signs and Oxygen saturation (SpO2) scores. 6-MWT, Borg scale for dyspnea and fatigue, Dyspnea scale Index (TDI), KBILD questionnaire and MFIS will be also evaluated.
Enrollment
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Inclusion criteria
Signed patient explanation sheet and informed consent for participation in the study.
Men and women at the age from 18 through 75 years old.
History of acute coronavirus infection:
Severity of mMRC dyspnea ≥2 at screening and randomization.
Severity of exercise tolerance impairment at screening and randomization based on the 6-minute Walk Test:
The presence of foci of lung tissue seals such as "frosted glass" and/or interlobular septum seals, and/or areas of reticular changes in lung tissue, and/or the presence of areas (linear, focal) of lung tissue seals characteristic of COVID-19 confirmed by chest CT at screening. The percentage of lung tissue damage is ≥10%, but < 75% of the total lung volume.
The pulmonary diffusivity parameter is less than 80%, but more than 40% of predicted at the time of screening.
The patient's consent to use adequate contraception methods during the entire study and within 3 weeks after its completion. The adequate contraception methods include the use of the following:
Exclusion criteria
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Interventional model
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412 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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