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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

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;

Show all 17Show fewer

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.

Show all 20Show fewer

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 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 groups in NCT05516550
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.

Aug 2022Dec 2022

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

All SARS-CoV-2 Infection trials

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 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

412 patients with persistent lung damage and reduced exercise tolerance exertion after COVID-19 pneumonia are planned to be randomized.

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.

Related trials for SARS-CoV-2 Infection

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

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?

On the ClinicalTrials.gov record for NCT05516550.

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.