SARS-CoV-2 InfectionPhase 2/3NCT05516550
Study to Assess Efficacy and Safety of Treamid for Patients With Reduced Exercise Tolerance After COVID-19
A Phase 2/3 study testing Treamid, Treamid twice a day and Treamid once a day in people with SARS-CoV-2 Infection and Lung Fibrosis, run by PHARMENTERPRISES LLC.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SARS-CoV-2 Infection, Lung Fibrosis
- What is being tested?
- Treamid, Treamid twice a day and Treamid once a day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 412 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- The patient has a history of confirmed diagnosis of COVID-19 pneumonia, which resolved more than 2 weeks before screening;
- History of COVID-19 is confirmed by positive qualitative analysis of SARS-CoV-2 by polymerase chain reaction (PCR) or detection of SARS-CoV-2 antigens;
- Negative rapid test for SARS-CoV-2 antigen at screening and randomization;
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- Onset of first symptoms of COVID-19 from 42 to 120 days prior to randomization.
- 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:
- reduction of the distance traveled below the normal limit (< 80% of predicted) at the level of shortness of breath ≥2 units according to the Borg scale;
- severity of shortness of breath > 2 units according to the Borg scale, regardless of the presence of violations in the distance traveled.
- 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:
- oral or transdermal contraceptives;
- condom or diaphragm (barrier method) with spermicide;
- intrauterine device.
Who cannot join
- Hypersensitivity to Treamid (active pharmaceutical substance XC268BG) and/or other components of the study drug.
- History of invasive mechanical ventilation and high-flow oxygenation in the last 45 days or need for oxygen support at screening and randomization.
- Chronic respiratory diseases diagnosed before COVID-19, including idiopathic pulmonary fibrosis and other interstitial lung diseases, moderate to severe bronchial asthma, moderate to severe chronic obstructive pulmonary disease, tuberculosis (including suspected tuberculosis based on CT examination at screening) or pulmonary hypertension.
- Severe anemia (Haemoglobin < 70 g/L at screening).
- Inability to perform a CT procedure (for example, a gypsum bandage or metal structures in the study area).
- Severe cardiovascular disease at present or within 6 months prior to screening, including: Class III or IV chronic heart failure (New York Heart Association classification), clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction, heart and coronary vessel surgery, significant heart valve disease, uncontrolled hypertension with systolic blood pressure > 180 mmHg and diastolic blood pressure > 110 mmHg, pulmonary embolism arteries or deep vein thrombosis.
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- Chronic kidney disease or other significant kidney disease with glomerular filtration rate (GFR) < 60 mL/min (Cockcroft-Gault formula) at screening. Hemodialysis requirement at patient screening.
- Stage II chronic liver failure (decompensated) and above; History of liver cirrhosis; alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevations of 3 or more times the upper limit of normal (ULN) at screening; increase in total bilirubin 2 or more times from ULN at screening (exception - Gilbert's syndrome in the history).
- Severe diseases of the central nervous system, including a history of seizures or conditions that may lead to their development; stroke or transient ischemic attack within 6 months prior to screening; traumatic brain injury or loss of consciousness within 6 months prior to screening; brain tumor.
- Malignancies requiring chemotherapy treatment within 5 years prior to screening or currently suspected cancer.
- Participation in other clinical trials within 1.5 months prior to screening.
- Requirement for or administration of the following drugs for 1 month prior to screening: erythropoietin, cytostatics, colchicine, cyclosporin A, interferon- γ -1b, bosentan, macitentan, etanercept, sildenafil, imatinib, warfarin, ambrisentan, nintedanib, pirfenidone, hyaluronidase asoxime 1 month prior to screening; glucocorticosteroids and N-acetylcysteine (requirement or 7 days prior to screening)
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
- Signs of a marked uncontrolled concomitant disease, such as disorders of the nervous system, kidney, liver, endocrine system and gastrointestinal tract, which, in the opinion of the Investigator, could prevent the patient from participating in the study.
- Positive test for human immunodeficiency virus (HIV), hepatitis B and/or C.
- Alcohol or drug addiction, history of mental illness.
- Severe, decompensated or unstable somatic diseases (any diseases or conditions that threaten the patient's life or impair the patient's prognosis, and make it impossible for him to participate in a clinical trial).
- Patient's unwillingness or inability to comply with Protocol procedures (in the opinion of the study physician).
- Pregnancy or breastfeeding period.
- Other conditions that, in the opinion of the study physician, prevent the patient from entering the study.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Treamid in the Treatment of Patients With Persistent Lung Damage and Reduced Exercise Tolerance Following Acute Coronavirus Infection
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.
Read the detailed 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.
- Conditions
- SARS-CoV-2 Infection, Lung Fibrosis
- Being tested
- Treamid, Treamid twice a day, Treamid once a day, Placebo
- Keywords
- COVID-19, Tolerance to physical activity
- Medical subject headings
- COVID-19, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreamidDrug
Participants will receive Treamid 25 mg once a day daily during 4 weeks
Treamid twice a dayDrug
Participants will receive Treamid 25 mg in the morning and in the evening daily during 4 weeks
Treamid once a dayDrug
Participants will receive Treamid 50 mg in the morning daily during 4 weeks
PlaceboDrug
Participants will receive Placebo in the morning and in the evening daily during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treamid 25 mg | Experimental | 1 tablet of Treamid 25 mg + 1 tablet of Placebo in the morning and 2 tablets of Placebo in the evening daily during 4 weeks of treatment period. Receives: Drug: Treamid |
| Treamid 50 mg twice a day | Experimental | 1 tablet of Treamid 25 mg + 1 tablet of Placebo in the morning and 1 tablet of Treamid 25 mg + 1 tablet of Placebo in the evening daily during 4 weeks of treatment period. Receives: Drug: Treamid twice a day |
| Treamid 50 mg once a day | Experimental | 2 tablets of Treamid 25 mg in the morning and 2 tablets of Placebo in the evening daily during 4 weeks of treatment period. Receives: Drug: Treamid once a day |
| Placebo | Placebo comparator | 2 tablets of Placebo in the morning and 2 tablets of Placebo in the evening daily during 4 weeks of treatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinically significant recovery of exercise tolerance (based on the 6MWD) from baseline values compared to Placebo.
Clinically significant recovery of exercise tolerance is considered for patients with no significant abnormalities (Distance ≥ lower limit of normal), clinically significant decrease in the Borg dyspnea score (≥1 points), in the absence of a decrease in the distance traveled from the baseline values; for patients with severe abnormalities (Distance < lower limit of normal distance), clinically significant increase in the distance traveled by 54 or more meters with a decrease in the Borg dyspnea score (≥ 0.5 points) from the baseline values.
Measured: Day 1- Day 29
Secondary outcomes (7)
Frequency of clinically significant change in lung diffusion capacity adjusted for hemoglobin (% of predicted) from baseline values compared to Placebo.
Measured: Day 1- Day 29
Rate of clinically significant recovery of exercise tolerance improvement using the Borg scale score at Visit 3, Visit 4, and Visit 5 from baseline values compared to Placebo.
Measured: Day 1- Day 56
Rate of clinically significant reduction in dyspnea by BDI/TDI scales at Visit 4 and Visit 5 from baseline values compared to Placebo.
Measured: Day 1- Day 56
Rate of clinically significant fatigue reduction assessed by change in MFIS fatigue score at Visit 4 and Visit 5 from baseline values compared to Placebo.
Measured: Day 1- Day 56
Rate of clinically significant reductions in Anxiety and Depression score assessed by HADS at Visit 4 and Visit 5 from baseline values compared to Placebo.
Measured: Day 1- Day 56
Rate of clinically significant increase in total KBILD score at Visit 4 and Visit 5 from baseline values compared to Placebo.
Measured: Day 1- Day 56
Rate of Clinically Significant Change in Patient Status on the Overall Clinical Impression Scale (CGI-S/CGI-I) at Visit 4 and Visit 5 from baseline values compared to Placebo.
Measured: Day 1- Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study startAug 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PHARMENTERPRISES LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516550
- Sponsor's protocol ID
- COVID-TRE-04
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Treamid in the Treatment of Patients With Persistent Lung Damage and Reduced Exercise Tolerance Following Acute Coronavirus Infection
- ClinicalTrials.gov ID
- NCT05516550
- Acronym / sponsor ID
- COVID-TRE-04
- Conditions
- SARS-CoV-2 Infection, Lung Fibrosis
- Keywords
- COVID-19, Tolerance to physical activity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- PHARMENTERPRISES LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treamid 25 mg | Experimental | Drug: Treamid1 tablet of Treamid 25 mg + 1 tablet of Placebo in the morning and 2 tablets of Placebo in the evening daily during 4 weeks of treatment period. |
| Treamid 50 mg twice a day | Experimental | Drug: Treamid twice a day1 tablet of Treamid 25 mg + 1 tablet of Placebo in the morning and 1 tablet of Treamid 25 mg + 1 tablet of Placebo in the evening daily during 4 weeks of treatment period. |
| Treamid 50 mg once a day | Experimental | Drug: Treamid once a day2 tablets of Treamid 25 mg in the morning and 2 tablets of Placebo in the evening daily during 4 weeks of treatment period. |
| Placebo | Placebo comparator | Drug: Placebo2 tablets of Placebo in the morning and 2 tablets of Placebo in the evening daily during 4 weeks of treatment period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (20 listed)
- Hypersensitivity to Treamid (active pharmaceutical substance XC268BG) and/or other components of the study drug.
- History of invasive mechanical ventilation and high-flow oxygenation in the last 45 days or need for oxygen support at screening and randomization.
- Chronic respiratory diseases diagnosed before COVID-19, including idiopathic pulmonary fibrosis and other interstitial lung diseases, moderate to severe bronchial asthma, moderate to severe chronic obstructive pulmonary disease, tuberculosis (including suspected tuberculosis based on CT examination at screening) or pulmonary hypertension.
- Severe anemia (Haemoglobin < 70 g/L at screening).
- Inability to perform a CT procedure (for example, a gypsum bandage or metal structures in the study area).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreamidParticipants will receive Treamid 25 mg once a day daily during 4 weeks | Drug | Treamid 25 mg |
| Treamid twice a dayParticipants will receive Treamid 25 mg in the morning and in the evening daily during 4 weeks | Drug | Treamid 50 mg twice a day |
| Treamid once a dayParticipants will receive Treamid 50 mg in the morning daily during 4 weeks | Drug | Treamid 50 mg once a day |
| PlaceboParticipants will receive Placebo in the morning and in the evening daily during 4 weeks | Drug | Placebo |
Primary outcome
Rate of clinically significant recovery of exercise tolerance (based on the 6MWD) from baseline values compared to Placebo.
Time frame: Day 1- Day 29
Clinically significant recovery of exercise tolerance is considered for patients with no significant abnormalities (Distance ≥ lower limit of normal), clinically significant decrease in the Borg dyspnea score (≥1 points), in the absence of a decrease in the distance traveled from the baseline values; for patients with severe abnormalities (Distance < lower limit of normal distance), clinically significant increase in the distance traveled by 54 or more meters with a decrease in the Borg dyspnea score (≥ 0.5 points) from the baseline values.
7 secondary outcomes
Frequency of clinically significant change in lung diffusion capacity adjusted for hemoglobin (% of predicted) from baseline values compared to Placebo.
Time frame: Day 1- Day 29
Rate of clinically significant recovery of exercise tolerance improvement using the Borg scale score at Visit 3, Visit 4, and Visit 5 from baseline values compared to Placebo.
Time frame: Day 1- Day 56
Rate of clinically significant reduction in dyspnea by BDI/TDI scales at Visit 4 and Visit 5 from baseline values compared to Placebo.
Time frame: Day 1- Day 56
Rate of clinically significant fatigue reduction assessed by change in MFIS fatigue score at Visit 4 and Visit 5 from baseline values compared to Placebo.
Time frame: Day 1- Day 56
Rate of clinically significant reductions in Anxiety and Depression score assessed by HADS at Visit 4 and Visit 5 from baseline values compared to Placebo.
Time frame: Day 1- Day 56
Rate of clinically significant increase in total KBILD score at Visit 4 and Visit 5 from baseline values compared to Placebo.
Time frame: Day 1- Day 56
Rate of Clinically Significant Change in Patient Status on the Overall Clinical Impression Scale (CGI-S/CGI-I) at Visit 4 and Visit 5 from baseline values compared to Placebo.
Time frame: Day 1- Day 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Treamid, Treamid twice a day and Treamid once a day in people with SARS-CoV-2 Infection and Lung Fibrosis, run by PHARMENTERPRISES LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinically significant recovery of exercise tolerance (based on the 6MWD) from baseline values compared to Placebo. (time frame: Day 1- Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.