COVID-19NCT07134738
Dimolegin® (60 mg) for Patients With Moderate COVID-19: A Non-Interventional Study
An observational study of COVID-19, run by Avexima Diol LLC at 6 sites in Russia.
Trial summary
A multicenter, open-label, non-interventional study evaluates the safety and tolerability of oral Dimolegin® (60 mg once daily) for thromboprophylaxis in hospitalized adults (≥18 years) with moderate COVID-19 in real clinical pratice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Dimolegin
- Type of treatment
- Pill or oral medicine
- How many people
- 184 participants
- Where
- 6 sitesRussia
- Study dates
- 7 Jun 2024to 15 Jan 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized adult patients (≥18 years) with moderate COVID-19 requiring thromboprophylaxis.
Who may be able to join
- Here's a concise English translation:
- Voluntarily signed informed consent to participate in a non-interventional study.
- Hospitalized patients with moderate COVID-19 requiring anticoagulant therapy for prevention of thrombotic complications.
- Men and women aged ≥18 years.
- Patients prescribed Dimolegin® 10 mg enteric-coated film tablets for thromboprophylaxis as part of routine care for moderate COVID-19.
- Ability to understand study requirements, provide written consent and comply with protocol procedures.
Who cannot join
- Hypersensitivity to Dimolegin®.
- Clinically significant active bleeding at screening.
- Concomitant therapy with fibrinolytics or other anticoagulants.
- Anemia or thrombocytopenia.
- Thrombophilia.
- Other coagulopathies or contraindications to anticoagulants.
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- Liver disease with impaired function or biliary tract disease.
- Creatinine clearance <30 mL/min.
- Gastrointestinal disorders affecting absorption.
- Pregnancy, breastfeeding, suspected pregnancy, or planned pregnancy within 3 months (including male patients whose partners plan pregnancy).
- Use of investigational or unapproved drugs, or participation in another clinical study within 90 days before therapy start.
- History or suspicion of alcohol or drug abuse, dependence, or addiction.
- Any other condition that, in the investigator's opinion, could interfere with study participation or pose undue risk.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
Regional Clinical Hospital No. 3
Chelyabinsk
Republican Clinical Hospital named after Professor A.F. Agafonov
Kazan'
Infectious Diseases Clinical Hospital No. 1
Moscow
Infectious Diseases Hospital No. 2
Sochi
Tomsk Regional Hospital
Tomsk
Regional Infectious Diseases Clinical Hospital
Yaroslavl
About this study
Official title: Multicenter, Open-label, Non-interventional Study to Assess the Safety and Tolerability of Dimolegin® as a Means of Preventing Thrombotic Complications in the Complex Therapy of Hospitalized Patients With Moderate COVID-19 in a Real Clinical Practice
A multicenter, open-label, non-interventional study evaluates the safety and tolerability of oral Dimolegin® (60 mg once daily) for thromboprophylaxis in hospitalized adults (≥18 years) with moderate COVID-19 in real clinical pratice. The primary objective is to assess safety and tolerability of Dimolegin® in preventing thrombotic complications.
- Conditions
- COVID-19
- Being tested
- Dimolegin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DimoleginDrug
Dimolegin® is administered orally once daily,The recommended dose is 60 mg (six 10 mg tablets) once daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 (Dimolegin® Group) | Dimolegin® is administered orally once dailyюThe recommended dose is 60 mg once daily. Treatment duration depends on clinical indication and may last up to 30 days. Receives: Drug: Dimolegin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of major bleeding events
Measured: through discharge from the hospital, up to 30 days
Secondary outcomes (8)
Frequency of major bleeding events
Measured: up to 60±3 days
Frequency of moderate bleeding events
Measured: up to 60±3 days
Frequency of minor bleeding events
Measured: up to 60±3 days
Frequency of anemia
Measured: up to 60±3 days
Frequency of AR of special interest regardless of severity
Measured: up to 60±3 days
Proportion of patients with ARs and SARs
Measured: up to 60±3 days
Change from baseline in INR, APTT, prothrombin time, and D-dimer levels
Measured: through discharge from the hospital, up to 30 days
Frequency of gastrointestinal symptoms
Measured: through discharge from the hospital, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start7 Jun 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
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 COVID-19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avexima Diol LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134738
- Sponsor's protocol ID
- AVD-DIM-PM-2023-15
- Status last verified
- Jan 2026
- First submitted
- 8 Aug 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chulanov V, Sagalova O, Khaertynov H, Teteneva A, Kravchenko I, Balashov O, Makarov D, Sychev D. Safety of a Domestic Original Direct Oral Anticoagulant from the Group of Factor Xa Inhibitors in the Prevention of Thrombotic Complications in Patients with COVID-19 in Real Clinical Practice. Clinical infectology and parasitology. 2025, 14 (3): 347-361. (In Russ.) DOI: 10.34883/PI.2025.14.3.038
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Non-interventional Study to Assess the Safety and Tolerability of Dimolegin® as a Means of Preventing Thrombotic Complications in the Complex Therapy of Hospitalized Patients With Moderate COVID-19 in a Real Clinical Practice
- ClinicalTrials.gov ID
- NCT07134738
- Acronym / sponsor ID
- AVD-DIM-PM-2023-15
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Avexima Diol LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 21 Aug 2025 (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.
A multicenter, open-label, non-interventional study evaluates the safety and tolerability of oral Dimolegin® (60 mg once daily) for thromboprophylaxis in hospitalized adults (≥18 years) with moderate COVID-19 in real clinical pratice. The primary objective is to assess safety and tolerability of Dimolegin® in preventing thrombotic complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 (Dimolegin® Group) | – | Drug: DimoleginDimolegin® is administered orally once dailyюThe recommended dose is 60 mg once daily. Treatment duration depends on clinical indication and may last up to 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized adult patients (≥18 years) with moderate COVID-19 requiring thromboprophylaxis.
Key inclusion criteria (6 listed)
- Voluntarily signed informed consent to participate in a non-interventional study.
- Hospitalized patients with moderate COVID-19 requiring anticoagulant therapy for prevention of thrombotic complications.
- Men and women aged ≥18 years.
- Patients prescribed Dimolegin® 10 mg enteric-coated film tablets for thromboprophylaxis as part of routine care for moderate COVID-19.
- Ability to understand study requirements, provide written consent and comply with protocol procedures.
Key exclusion criteria (13 listed)
- Hypersensitivity to Dimolegin®.
- Clinically significant active bleeding at screening.
- Concomitant therapy with fibrinolytics or other anticoagulants.
- Anemia or thrombocytopenia.
- Thrombophilia.
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 |
|---|---|---|
| DimoleginDimolegin® is administered orally once daily,The recommended dose is 60 mg (six 10 mg tablets) once daily. | Drug | 1 (Dimolegin® Group) |
Primary outcome
Frequency of major bleeding events
Time frame: through discharge from the hospital, up to 30 days
8 secondary outcomes
Frequency of major bleeding events
Time frame: up to 60±3 days
Frequency of moderate bleeding events
Time frame: up to 60±3 days
Frequency of minor bleeding events
Time frame: up to 60±3 days
Frequency of anemia
Time frame: up to 60±3 days
Frequency of AR of special interest regardless of severity
Time frame: up to 60±3 days
Proportion of patients with ARs and SARs
Time frame: up to 60±3 days
Change from baseline in INR, APTT, prothrombin time, and D-dimer levels
Time frame: through discharge from the hospital, up to 30 days
Frequency of gastrointestinal symptoms
Time frame: through discharge from the hospital, up to 30 days
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 16 Jan 2026.
- Results publicationChulanov V, Sagalova O, Khaertynov H, Teteneva A, Kravchenko I, Balashov O, Makarov D, Sychev D. Safety of a Domestic Original Direct Oral Anticoagulant from the Group of Factor Xa Inhibitors in the Prevention of Thrombotic Complications in Patients with COVID-19 in Real Clinical Practice. Clinical infectology and parasitology. 2025, 14 (3): 347-361. (In Russ.) DOI: 10.34883/PI.2025.14.3.038
- Individual participant dataSharing planned: No
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Avexima Diol LLC at 6 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 6 inclusion and 13 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Frequency of major bleeding events (time frame: through discharge from the hospital, up to 30 days). 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 NCT07134738, 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 16 Jan 2026.