Effect of the Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID-19 Pneumonia

• ClinicalTrials.gov Identifier: NCT04871802
• Recruitment Status: Unknown
• First Posted: May 4, 2021
• Last Update Posted: May 4, 2021
• Sponsor: Pirogov Russian National Research Medical University
• Information provided by (Responsible Party): Pirogov Russian National Research Medical University

Tracking Information

• First Submitted Date: March 21, 2021
• First Posted Date: May 4, 2021
• Last Update Posted Date: May 4, 2021
• Estimated Study Start Date: May 10, 2021
• Estimated Primary Completion Date: September 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 1, 2021)

• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 1, 2021)

Dynamics of biological age [ Time Frame: In 2 months after recruitment ]

Laboratory indicators

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of the Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID-19 Pneumonia
• 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
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Covid19

Intervention

Dietary Supplement: Taxifolin Aqua

Dietary supplement

Study Arms

• Experimental: Taxifolin Aqua group
  Taxifolin Aqua 30 mg per day in addition to standard therapy
  Intervention: Dietary Supplement: Taxifolin Aqua
• No Intervention: Control group
  No intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 1, 2021): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 1, 2021
• Estimated Primary Completion Date: September 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Standard contraindications to Taxifolin Aqua use.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Russian Federation

Administrative Information

• NCT Number: NCT04871802
• Other Study ID Numbers: COVID-AQUA-1
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Pirogov Russian National Research Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: Pirogov Russian National Research Medical University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Irina Strazhesko, MD, PhD; Clinical Reserach Center for Gerontology

• PRS Account: Pirogov Russian National Research Medical University
• Verification Date: March 2021