SARS-CoV-2 InfectionPhase 2NCT04527354
Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia
A Phase 2 study testing Treamid in people with SARS-CoV-2 Infection and Fibrosis Lung, run by PHARMENTERPRISES LLC at 8 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SARS-CoV-2 Infection, Fibrosis Lung
- What is being tested?
- Treamid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 8 sitesRussia
- Study dates
- 1 Sep 2020to 10 Feb 2021
- Phase
- Phase 2
- 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.
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Inability to read or write; unwillingness to understand and follow the procedures of the study protocol; noncompliance with the drugs administration or procedures schedule, which according to the researchers may affect the study results or the patient safety and prevent the further participation of the patient in the study; any other associated medical or serious mental conditions that make the patient inadequate for participation in the clinical study and restrict the validity of informed consent or may affect the patient's ability to participate in the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Russia8 sites
Federal State-Funded Research Institution "Research Institute of Complex Cardiovascular Diseases"
Kemerovo, 650002
Federal State Budgetary Institution "N.N. Burdenko Military Clinical Hospital"
Moscow, 105094
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
Moscow State Medical-Dentist University n.a. A.I. Evdokimov on basis of SMHI "City Hospital № 62", branch 5
Moscow, 121552
State Budgetary Health Institution "Republican Hospital named V.A.Baranov"
Petrozavodsk, 185019
Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"
Rostov-on-Don, 344068
LLC "Medical Center "Reavita Med St. Petersburg"
Saint Petersburg, 194354
State autonomous healthcare institution of Yaroslavl Region "Сlinical hospital for emergency medical care n. a. N.V. Solovyov"
Yaroslavl, 150003
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Pilot Study of Treamid Efficacy and Safety in the Rehabilitation of Patients After COVID-19 Pneumonia
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).
Read the detailed description
12-15 Russian centers are planned for participation in this pilot study. The study consists of three periods: screening (2 weeks), treatment period (4 weeks) and follow-up period (2 weeks after completion of treatment with Treamid / Placebo). The duration of participation in the study for each patient is no more than 8 weeks.
60 patients with fibrotic changes in the lungs after COVID-19 pneumonia are planned to be randomized. All patients will undergo a qualitative determination of coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by polymerase chain reaction (PCR). Patients will be evaluated using the Modified British Medical Research Council (mMRC) Dyspnea Scale, chest computed tomography (CT), spirometry and body plethysmography with determination of DLCO. This examination should be conducted as close as possible to the expected randomization date (no earlier than 5 days before). All eligible patients will be randomized into 2 groups in a 1:1 ratio: Treamid 50 mg daily (30 patients); Placebo (30 patients).
During the treatment period (4 weeks), patients will receive 1 tablet Treamid / Placebo once a day. Patients will be advised to continue the standard program of medical rehabilitation under day inpatient or outpatient conditions (stage 3 according to the Interim Guidelines for Medical Rehabilitation after New Coronavirus Infection (COVID-19), 2020.
Patients will visit the study center once a week. At the Week 1, Week 2 and Week 3 visits, Adverse events (AEs) and concomitant therapy, investigational drug registration, body weight, vital signs and Oxygen saturation (SpO2) scores, mMRC dyspnea score and spirometry will be recorded.
During the Week 2 visit, physical examination, electrocardiography (ECG), complete blood count (CBC) and biochemical blood test, PK study, common urine analysis, bodyplethysmography with DLCO will also be conducted. Patients will complete the KBILD questionnaire. Also, the patients will undergo a 6-minute walk test to measure the distance the patient walks for 6 minutes and evaluate using the Borg Scale. At the Week 4 visit (the end of the therapy), registration of AEs and concomitant therapy, physical examination, measurement of height, body weight, vital signs and SpO2, ECG, CBC and biochemical blood tests, PK study and common urine analysis will be conducted. Patients will be evaluated using the mMRC Dyspnea Scale, chest CT, spirometry and body plethysmography with determination of DLCO. Patients will complete the King's Brief Interstitial Lung Disease Questionnaire (KBILD) followed by a 6-minute walk test to measure the distance the patient walks for 6 minutes and evaluate using the Borg Scale.
Patient follow-up will continue for another 2 weeks. At the Week 6 visit, registration of AEs and concomitant therapy, physical examination, measurement of height, body weight, vital signs and SpO2, ECG, mMRC dyspnea score, CBC and biochemical blood tests, and common urine analysis will be conducted.
- Conditions
- SARS-CoV-2 Infection, Fibrosis Lung
- Being tested
- Treamid, Placebo
- Keywords
- COVID-19, Coronavirus, Rehabilitation
- Medical subject headings
- COVID-19, Pulmonary Fibrosis, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreamidDrug
Participants will receive Treamid 50 mg once a day during 4 weeks
PlaceboDrug
Participants will receive Placebo once a day during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treamid 50 mg | Experimental | 1 tablet of Treamid 50 mg once a day during 4 weeks of treatment period. Receives: Drug: Treamid |
| Placebo | Placebo comparator | 1 tablet of Placebo once a day 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 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: Day 1- Day 28
Change in FVC according to spirometry data at Weeks 1, 2, 3 and 4 relative to the baseline values
Measured: Day 1- Day 28
Change in FEV1/FVC according to spirometry data at Weeks 1, 2, 3 and 4 relative to the baseline values
Measured: Day 1- Day 28
Change in DLCO according to bodyplethysmography at Week 2 and Week 4 relative to baseline values
Measured: Day 1- Day 28
Change in Total Lung Capacity (TLC) according to bodyplethysmography at Week 2 and Week 4 relative to baseline values
Measured: Day 1- Day 28
Change in Functional Residual Capacity (FRC) according to bodyplethysmography at Week 2 and Week 4 relative to baseline values
Measured: Day 1- Day 28
The rate of reduction in the lung damage degree based on the computed tomography (CT) at Week 4 relative to the baseline value
Classification of lung damage includes the following stages: CT-0 (norm), CT-1 (< 25% of lung damage), CT-2 (25-50% of lung damage), CT-3 (50-75% of lung damage), CT-4 (> 75% of lung damage)
Measured: Day 1- Day 28
Change in mMRC Dyspnea Score in Week 1, Week 2, Week 3, and Week 4 from the baseline value
Measured: Day 1- Day 28
Change in the overall score of the KBILD Questionnaire at Week 2 and Week 4 relative to the baseline value
Measured: Day 1- Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start1 Sep 2020
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- PHARMENTERPRISES LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527354
- Sponsor's protocol ID
- COVID-TRE-03
- Status last verified
- Mar 2021
- First submitted
- 24 Aug 2020
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36329513
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled Pilot Study of Treamid Efficacy and Safety in the Rehabilitation of Patients After COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04527354
- Acronym / sponsor ID
- COVID-TRE-03
- Conditions
- SARS-CoV-2 Infection, Fibrosis Lung
- Keywords
- COVID-19, Coronavirus, Rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PHARMENTERPRISES LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 26 Aug 2020 (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 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).
Detailed description
12-15 Russian centers are planned for participation in this pilot study. The study consists of three periods: screening (2 weeks), treatment period (4 weeks) and follow-up period (2 weeks after completion of treatment with Treamid / Placebo). The duration of participation in the study for each patient is no more than 8 weeks.
60 patients with fibrotic changes in the lungs after COVID-19 pneumonia are planned to be randomized. All patients will undergo a qualitative determination of coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by polymerase chain reaction (PCR). Patients will be evaluated using the Modified British Medical Research Council (mMRC) Dyspnea Scale, chest computed tomography (CT), spirometry and body plethysmography with determination of DLCO. This examination should be conducted as close as possible to the expected randomization date (no earlier than 5 days before). All eligible patients will be randomized into 2 groups in a 1:1 ratio: Treamid 50 mg daily (30 patients); Placebo (30 patients).
During the treatment period (4 weeks), patients will receive 1 tablet Treamid / Placebo once a day. Patients will be advised to continue the standard program of medical rehabilitation under day inpatient or outpatient conditions (stage 3 according to the Interim Guidelines for Medical Rehabilitation after New Coronavirus Infection (COVID-19), 2020.
Patients will visit the study center once a week. At the Week 1, Week 2 and Week 3 visits, Adverse events (AEs) and concomitant therapy, investigational drug registration, body weight, vital signs and Oxygen saturation (SpO2) scores, mMRC dyspnea score and spirometry will be recorded.
During the Week 2 visit, physical examination, electrocardiography (ECG), complete blood count (CBC) and biochemical blood test, PK study, common urine analysis, bodyplethysmography with DLCO will also be conducted. Patients will complete the KBILD questionnaire. Also, the patients will undergo a 6-minute walk test to measure the distance the patient walks for 6 minutes and evaluate using the Borg Scale. At the Week 4 visit (the end of the therapy), registration of AEs and concomitant therapy, physical examination, measurement of height, body weight, vital signs and SpO2, ECG, CBC and biochemical blood tests, PK study and common urine analysis will be conducted. Patients will be evaluated using the mMRC Dyspnea Scale, chest CT, spirometry and body plethysmography with determination of DLCO. Patients will complete the King's Brief Interstitial Lung Disease Questionnaire (KBILD) followed by a 6-minute walk test to measure the distance the patient walks for 6 minutes and evaluate using the Borg Scale.
Patient follow-up will continue for another 2 weeks. At the Week 6 visit, registration of AEs and concomitant therapy, physical examination, measurement of height, body weight, vital signs and SpO2, ECG, mMRC dyspnea score, CBC and biochemical blood tests, and common urine analysis will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treamid 50 mg | Experimental | Drug: Treamid1 tablet of Treamid 50 mg once a day during 4 weeks of treatment period. |
| Placebo | Placebo comparator | Drug: Placebo1 tablet of Placebo once a day 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 (13 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.
- Fibrous changes in the lungs after COVID-19 pneumonia:
- 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.
Key exclusion criteria (16 listed)
- 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.
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 50 mg once a day during 4 weeks | Drug | Treamid 50 mg |
| PlaceboParticipants will receive Placebo once a day during 4 weeks | Drug | Placebo |
Primary outcome
Rate of clinically significant change in FVC and/or DLCO at Week 4 relative to the baseline value
Time frame: Day 1- Day 28
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
11 secondary outcomes
Change in distance covered for 6 minutes (6MWD) at Weeks 2 and 4 from the baseline value (based on 6-minute walk test)
Time frame: 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)
Time frame: 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
Time frame: Day 1- Day 28
Change in FVC according to spirometry data at Weeks 1, 2, 3 and 4 relative to the baseline values
Time frame: Day 1- Day 28
Change in FEV1/FVC according to spirometry data at Weeks 1, 2, 3 and 4 relative to the baseline values
Time frame: Day 1- Day 28
Change in DLCO according to bodyplethysmography at Week 2 and Week 4 relative to baseline values
Time frame: Day 1- Day 28
Change in Total Lung Capacity (TLC) according to bodyplethysmography at Week 2 and Week 4 relative to baseline values
Time frame: Day 1- Day 28
Change in Functional Residual Capacity (FRC) according to bodyplethysmography at Week 2 and Week 4 relative to baseline values
Time frame: Day 1- Day 28
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 28
Change in mMRC Dyspnea Score in Week 1, Week 2, Week 3, and Week 4 from the baseline value
Time frame: Day 1- Day 28
Change in the overall score of the KBILD Questionnaire at Week 2 and Week 4 relative to the baseline value
Time frame: Day 1- Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Derived from this study: PubMed 36329513Bazdyrev 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.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treamid in people with SARS-CoV-2 Infection and Fibrosis Lung, run by PHARMENTERPRISES LLC at 8 sites in Russia.
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 13 inclusion and 16 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: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 change in FVC and/or DLCO at Week 4 relative to the baseline value (time frame: Day 1- Day 28). 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 NCT04527354, which also lists 1 linked publication.
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 5 Apr 2021.