Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia

NCT04527354 | Completed Phase 2 DMC

• 1 other identifier: COVID-TRE-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 8

Brief 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).

Conditions

SARS-CoV-2 Infection; Fibrosis Lung

Keywords

COVID-19; Coronavirus; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Rate of clinically significant change in FVC and/or DLCO at Week 4 relative to the baseline value

  Clinically significant changes include a relative ≥ 10% increase in FVC or a relative increase in FVC within the range from ≥ 5% to \<10% and a relative ≥ 15% in DLCO

  Day 1- Day 28

Secondary Outcomes (11)

• Change in distance covered for 6 minutes (6MWD) at Weeks 2 and 4 from the baseline value (based on 6-minute walk test)

  Day 1- Day 28

• Change in the score of the Borg scale at Weeks 2 and 4 from the baseline value (based on the 6-minute walk test)

  Day 1- Day 28

• Change in forced expiratory volume for the first second (FEV1) according to spirometry data at Weeks 1, 2, 3 and 4 relative to the baseline values

  Day 1- Day 28

• Change in FVC according to spirometry data at Weeks 1, 2, 3 and 4 relative to the baseline values

  Day 1- Day 28

• Change in FEV1/FVC according to spirometry data at Weeks 1, 2, 3 and 4 relative to the baseline values

  Day 1- Day 28

Other Outcomes (3)

• The rate of adverse events (AEs)

  Day 1- Day 28

• The rate of serious adverse events (SAEs)

  Day 1- Day 28

• Residual concentration Ctrough of the active substance of Treamid

  Day 1- Day 28

Study Arms (2)

Treamid 50 mg

EXPERIMENTAL

1 tablet of Treamid 50 mg once a day during 4 weeks of treatment period.

Drug: Treamid

Placebo

PLACEBO COMPARATOR

1 tablet of Placebo once a day during 4 weeks of treatment period

Drug: Placebo

Interventions

Treamid DRUG

Participants will receive Treamid 50 mg once a day during 4 weeks

Treamid 50 mg

Placebo DRUG

Participants will receive Placebo once a day during 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed patient explanation sheet and informed consent for participation in the study.
• Men and women at the age from 18 through 75 years old.
• Fibrous changes in the lungs after COVID-19 pneumonia:
• COVID-19 diagnosis in the past medical history confirmed by positive qualitative analysis of SARS-CoV-2 RNA by PCR method;
• The first symptoms of COVID-19 appear no earlier than 2 months before the screening visit;
• Fibrous changes in the lungs characteristic for COVID-19 confirmed by the chest CT scan at screening visit.
• Negative COVID-19 screening test (confirmed).
• Severity grade 2 (moderate) or 3 (severe) according to the mMRC Dyspnea Scale at the screening and randomization visits.
• Decreased lung function FVC and/or DLCO \<80% of the predicted value at the screening visit.
• The patient's consent to use adequate contraception methods during the entire study and within 3 months after its completion. The adequate contraception methods include the use of the following:
• oral or transdermal contraceptives;
• condom or diaphragm (barrier method) with spermicide;
• intrauterine device.

You may not qualify if:

• Pregnant or breastfeeding women, or women planning pregnancy during the clinical study; women with childbearing potential (including those who have not been sterilized by surgery and in the postmenopausal period for less than 2 years) who do not use adequate contraception methods.
• The use of invasive artificial lung ventilation (iALV), plasma transfusion (including plasma of convalescents) and other blood components during therapy against COVID-19.
• Chronic airway disease in the past medical history, including idiopathic pulmonary fibrosis (IPF), bronchial asthma, chronic obstructive pulmonary disease (COPD), or pulmonary hypertension, diagnosed before COVID-19.
• Significant cardiovascular diseases at present time or during 6 months prior to the screening, including: chronic heart failure class III or IV (according to the New York Heart Association classification), clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction, heart and coronary surgery, significant heart valves disease, uncontrolled hypertension with systolic blood pressure\> 180 mm Hg and diastolic blood pressure\> 110 mm Hg, thromboembolia of the pulmonary artery or deep vein thrombosis
• Nephrotic syndrome, moderate to severe chronic renal failure, or significant kidney disease with a glomerular filtration rate (GFR) \<60 ml/min at the screening visit.
• Cirrhosis of the liver in the past medical history; increase in alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) by 3 or more times from the upper normal level (UNL) at the screening visit; an increase in the total bilirubin level by 2 or more times from UNL at the screening visit.
• Hemoglobin level \<90 g/L at the screening visit.
• Severe diseases of the central nervous system, including seizures or conditions in the past medical history that can cause their development; stroke or transient ischemic attack within 6 months prior to the screening visit; traumatic brain injury or loss of consciousness within 6 months prior to the screening visit; a brain tumor.
• Signs of severe uncontrolled intercurrent disease, such as disorders of the nervous system, kidney, liver, endocrine system and gastrointestinal tract, which, in the opinion of the Investigator, could interfere with the patient's participation in the study.
• Malignant neoplasms requiring chemotherapy treatment within 6 months prior to the screening visit.
• HIV infection in the past-medical history.
• Prostate cancer or benign prostatic hyperplasia (BPH) with residual urine volume of more than 100 ml in the past medical history of men.
• Hypersensitivity or intolerance to any component of the investigated drug.
• Participation in other clinical studies within 2 months prior to the screening visit.
• Administration of the following medications: bronchodilators, anticholinergics, corticosteroids, cytostatics, colchicine, cyclosporin A, interferon-γ-1b, bosentan, macitentan, etanercept, sildenafil, imatinib, n-acetylcysteine, warfarin, ambrisentan, nintedanib, pirfenidone 1 month prior to the screening visit.

Sponsors & Collaborators

• PHARMENTERPRISES LLC: lead

Study Sites (8)

Federal State-Funded Research Institution "Research Institute of Complex Cardiovascular Diseases"

Kemerovo, 650002, Russia

Location

Federal State Budgetary Institution "N.N. Burdenko Military Clinical Hospital"

Moscow, 105094, Russia

Location

SBEI HPE The First Moscow State Medical University n.a. Sechenov of Ministry of Health of Russian Federation, University Hospital #2, Department of Development of New Medicines

Moscow, 119435, Russia

Location

Moscow State Medical-Dentist University n.a. A.I. Evdokimov on basis of SMHI "City Hospital № 62", branch 5

Moscow, 121552, Russia

Location

State Budgetary Health Institution "Republican Hospital named V.A.Baranov"

Petrozavodsk, 185019, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"

Rostov-on-Don, 344068, Russia

Location

LLC "Medical Center "Reavita Med St. Petersburg"

Saint Petersburg, 194354, Russia

Location

State autonomous healthcare institution of Yaroslavl Region "Сlinical hospital for emergency medical care n. a. N.V. Solovyov"

Yaroslavl, 150003, Russia

Location

Related Publications (1)

• Bazdyrev E, Panova M, Brachs M, Smolyarchuk E, Tsygankova D, Gofman L, Abdyusheva Y, Novikov F. Efficacy and safety of Treamid in the rehabilitation of patients after COVID-19 pneumonia: a phase 2, randomized, double-blind, placebo-controlled trial. J Transl Med. 2022 Nov 3;20(1):506. doi: 10.1186/s12967-022-03660-9.

  PMID: 36329513 DERIVED

MeSH Terms

Conditions

COVID-19; Pulmonary Fibrosis; Coronavirus Infections

Interventions

N,N'-bis(2-(1H-imidazol-2-yl)ethyl)pentanediamide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A blind will be performed by using Placebo equivalent to Treamid tablets without active substance and the corresponding labeling of the study drug.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 26, 2020
• Study Start: September 1, 2020
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-03

Locations

RU (8)