Covid19NCT04871802
Effect of the Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID-19 Pneumonia
A study testing Taxifolin Aqua in people with Covid19, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
Objective of the study is to evaluate the effect of Taxifolin Aqua therapy on the indicators of respiratory function, the state of the arterial wall, the contractile function of the myocardium, as well as to assess the effect of Taxifolin Aqua therapy on markers of biological age, quality of patients life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Taxifolin Aqua
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 10 May 2021to 1 Oct 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of both sexes who had covid pneumonia 3 months ago and signed an informed consent and aged 18+.
Who cannot join
- Standard contraindications to Taxifolin Aqua use.
Trial locations and contacts
1 site in 1 country.
Irina Strazhesko, MD, PhD contact
About this study
Official title: A Prospective, Randomized, Comparative Study in Two Groups to Assess the Effect of the Use of a Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID Pneumonia and on the Biological Age
Objective of the study is to evaluate the effect of Taxifolin Aqua therapy on the indicators of respiratory function, the state of the arterial wall, the contractile function of the myocardium, as well as to assess the effect of Taxifolin Aqua therapy on markers of biological age, quality of patients life.
Read the detailed description
The study will include 100 patients who had covid pneumonia 3 months ago. If the inclusion / exclusion criteria are met, the patient is asked to sign an informed consent to participate in the study. Consenting patients are randomized to an intervention group or a control group. The control group (n = 50) will receive standard therapy, patients from the intervention group (n = 50) will be prescribed Taxifolin Aqua 30 mg per day in addition to standard therapy. Patients will be randomized to the control and main group using random number spreadsheets, assuming that the control and main groups will be homogeneous in the main demographic and clinical parameters. Patient monitoring will be carried out within 2 months from the date of inclusion. A follow-up visit is scheduled in 2 months. During the study, the patient will be regularly monitored for tolerance and safety of therapy with Taxifolin Aqua.
- Conditions
- Covid19
- Being tested
- Taxifolin Aqua
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taxifolin AquaDietary supplement
Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Taxifolin Aqua group | Experimental | Taxifolin Aqua 30 mg per day in addition to standard therapy Receives: Dietary Supplement: Taxifolin Aqua |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamics of spirometry indices
spirometry
Measured: In 2 months after recruitment
Dynamics of ECHO CG
ECHO CG
Measured: In 2 months after recruitment
Dynamics of pulse wave velocity
applanation tonometry
Measured: In 2 months after recruitment
Dynamics of augmentation index
applanation tonometry
Measured: In 2 months after recruitment
Secondary outcomes (1)
Dynamics of biological age
Laboratory indicators
Measured: In 2 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start10 May 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irina Strazhesko, MD, PhD, Principal investigator, Clinical Reserach Center for Gerontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871802
- Sponsor's protocol ID
- COVID-AQUA-1
- Status last verified
- Mar 2021
- First submitted
- 21 Mar 2021
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Comparative Study in Two Groups to Assess the Effect of the Use of a Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID Pneumonia and on the Biological Age
- ClinicalTrials.gov ID
- NCT04871802
- Acronym / sponsor ID
- COVID-AQUA-1
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 10 May 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 4 May 2021 (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.
Objective of the study is to evaluate the effect of Taxifolin Aqua therapy on the indicators of respiratory function, the state of the arterial wall, the contractile function of the myocardium, as well as to assess the effect of Taxifolin Aqua therapy on markers of biological age, quality of patients life.
Detailed description
The study will include 100 patients who had covid pneumonia 3 months ago. If the inclusion / exclusion criteria are met, the patient is asked to sign an informed consent to participate in the study. Consenting patients are randomized to an intervention group or a control group. The control group (n = 50) will receive standard therapy, patients from the intervention group (n = 50) will be prescribed Taxifolin Aqua 30 mg per day in addition to standard therapy. Patients will be randomized to the control and main group using random number spreadsheets, assuming that the control and main groups will be homogeneous in the main demographic and clinical parameters. Patient monitoring will be carried out within 2 months from the date of inclusion. A follow-up visit is scheduled in 2 months. During the study, the patient will be regularly monitored for tolerance and safety of therapy with Taxifolin Aqua.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taxifolin Aqua group | Experimental | Dietary Supplement: Taxifolin AquaTaxifolin Aqua 30 mg per day in addition to standard therapy |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of both sexes who had covid pneumonia 3 months ago and signed an informed consent and aged 18+.
Key exclusion criteria (1 listed)
- Standard contraindications to Taxifolin Aqua use.
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 |
|---|---|---|
| Taxifolin AquaDietary supplement | Dietary supplement | Taxifolin Aqua group |
Primary outcome
Dynamics of spirometry indices
Time frame: In 2 months after recruitment
spirometry
Dynamics of ECHO CG
Time frame: In 2 months after recruitment
ECHO CG
Dynamics of pulse wave velocity
Time frame: In 2 months after recruitment
applanation tonometry
Dynamics of augmentation index
Time frame: In 2 months after recruitment
applanation tonometry
1 secondary outcome
Dynamics of biological age
Time frame: In 2 months after recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- 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.
Irina Strazhesko, MD, PhD contact
Irina Strazhesko, MD, PhD principal investigator
Clinical Reserach Center for Gerontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taxifolin Aqua in people with Covid19, run by Pirogov Russian National Research Medical University at 1 site 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 1 inclusion and 1 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 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irina Strazhesko, MD, PhD (Istrazhesko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamics of spirometry indices (time frame: In 2 months after recruitment). The study lists 4 primary outcomes in all. 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 4 May 2021.