NCT04871802

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

May 4, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 21, 2021

Last Update Submit

May 1, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Dynamics of spirometry indices

    spirometry

    In 2 months after recruitment

  • Dynamics of ECHO CG

    ECHO CG

    In 2 months after recruitment

  • Dynamics of pulse wave velocity

    applanation tonometry

    In 2 months after recruitment

  • Dynamics of augmentation index

    applanation tonometry

    In 2 months after recruitment

Secondary Outcomes (1)

  • Dynamics of biological age

    In 2 months after recruitment

Study Arms (2)

Taxifolin Aqua group

EXPERIMENTAL

Taxifolin Aqua 30 mg per day in addition to standard therapy

Dietary Supplement: Taxifolin Aqua

Control group

NO INTERVENTION

No intervention

Interventions

Taxifolin AquaDIETARY_SUPPLEMENT

Dietary supplement

Taxifolin Aqua group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of both sexes who had covid pneumonia 3 months ago and signed an informed consent and aged 18+.

You may not qualify if:

  • Standard contraindications to Taxifolin Aqua use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Russian Clinical Research Center for Gerontology

Moscow, 129226, Russia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Irina Strazhesko, MD, PhD

    Clinical Reserach Center for Gerontology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irina Strazhesko, MD, PhD

CONTACT

Olga Tkacheva, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2021

First Posted

May 4, 2021

Study Start

May 10, 2021

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

May 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations