A Phase 2/3 interventional study of Treamid and Treamid twice a day in SARS-CoV-2 Infection and Lung Fibrosis, sponsored by PHARMENTERPRISES LLC. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-08-25.
Sponsored by PHARMENTERPRISES LLC · Phase 2/3, Interventional, and Treatment
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.
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 412 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →PHARMENTERPRISES LLC is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
History of acute coronavirus infection:
Severity of exercise tolerance impairment at screening and randomization based on the 6-minute Walk Test:
The patient's consent to use adequate methods during the entire study and within 3 weeks after its completion. The adequate contraception methods include the use of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Treamid
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.
Drug: Treamid twice a day
2 tablets of Treamid 25 mg in the morning and 2 tablets of Placebo in the evening daily during 4 weeks of treatment period.
Drug: Treamid once a day
2 tablets of Placebo in the morning and 2 tablets of Placebo in the evening daily during 4 weeks of treatment period.
Drug: Placebo
Participants will receive Treamid 25 mg once a day daily during 4 weeks
Participants will receive Treamid 25 mg in the morning and in the evening daily during 4 weeks
Participants will receive Treamid 50 mg in the morning daily during 4 weeks
Participants will receive Placebo in the morning and in the evening daily during 4 weeks
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.
Time frame: Day 1- Day 29
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
Rate of clinically significant recovery of exercise tolerance (based on the 6MWD) in female patients from baseline values compared to Placebo.
Time frame: Day 1- Day 29
Change in DLCO according to bodyplethysmography at Week 4 relative to baseline values.
Time frame: Day 1- Day 29
Change in Total Lung Capacity (TLC) according to bodyplethysmography at Week 4 relative to baseline.
Time frame: Day 1- Day 29
The rate of reduction in the lung damage degree based on the computed tomography (CT) at Week 4 relative to the baseline value.
Time frame: Day 1- Day 29
Mean Change in Lung Lesion (Expressed as % of Total Lung Area) by CT at Week 4 relative to the baseline value.
Time frame: Day 1- Day 29
The rate of clinically significant increase in distance (54 or more meters) traveled within 6 minutes at Visit 3, Visit 4 and Visit 5 relative to the baseline value.
Time frame: Day 1- Day 56
Mean change in distance traveled over 6 minutes at Visit 3, Visit 4 and Visit 5 (based on the 6MWD) relative to the baseline value.
Time frame: Day 1- Day 56
Rate of clinically significant reduction in post-exercise dyspnea using the Borg scale score at Visit 3, Visit 4 and Visit 5 (based on the 6MWD) relative to the baseline value.
Time frame: Day 1- Day 56
Mean change in post-exercise dyspnea using the Borg scale score at Visit 3, Visit 4 and Visit 5 (based on the 6MWD) relative to the baseline value.
Time frame: Day 1- Day 56
Mean change in post-exercise fatigue using the Borg scale score at Visit 3, Visit 4 and Visit 5 (based on the 6MWD) relative to the baseline value.
Time frame: Day 1- Day 56
Mean change in mMRC dyspnea severity at Visit 4 and Visit 5 relative to the baseline value.
Time frame: Day 1- Day 56
Mean change in Anxiety and Depression score assessed by HADS at Visit 4 and Visit 5 relative to the baseline value.
Time frame: Day 1- Day 56
Mean change from baseline in standardized health-related quality of life score assessed on the EQ-5D-3L scale at Visit 4 and Visit 5 relative to the baseline value.
Time frame: Day 1- Day 56
Mean Change from Baseline in Total KBILD Score at Visit 3, Visit 4, and Visit 5 relative to the baseline value.
Time frame: Day 1- Day 56
The rate of adverse events (AEs)
Time frame: Day 1- Day 70
The rate of serious adverse events (SAEs)
Time frame: Day 1- Day 70
Total number and proportion of patients with one or more AEs
Time frame: Day 1- Day 70
Total number and proportion of patients who discontinued treatment due to AEs
Time frame: Day 1- Day 70
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Studies of the drug tested here: Treamid
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