NCT05081362

Brief Summary

The goal of the study is to assess autonomic nervous system and cardiovascular controll during orthostatic challenge in 90 patients recovered from COVID-19 and devided into three groups depend on severity of the morbidity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

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

October 7, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 18, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

October 7, 2021

Last Update Submit

January 23, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

  • Arterial pressure measured in mmHg

    Continuous measurement of the arterial pressure for 10 minutes in rest and 10 minutes in orthostatic position.

    6 months

  • Heart rate measured in bpm

    Continuous measurement of heart rate for 10 minutes in rest and 10 minutes in orthostatic position.

    6 months

  • Respiratory frequency

    Continuous measurement of respiratory frequency for 10 minutes in rest and 10 minutes in orthostatic position.

    6 months

Study Arms (3)

COVID-severe

OTHER

patient recovered from severe COVID desease

Other: Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity

COVID-moderate

OTHER

patient recovered from moderate COVID desease

Other: Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity

COVID-mild

OTHER

patient recovered from mild COVID desease

Other: Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity

Interventions

Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activityOTHER

Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity during ten minutes in rest and ten minutes in orthostatic position

COVID-mildCOVID-moderateCOVID-severe

Eligibility Criteria

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

You may qualify if:

  • age over 18
  • spontaneous sinus rhythm
  • signed informed consent

You may not qualify if:

  • no spontaneous sinus rhythm
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

Location

MeSH Terms

Conditions

COVID-19

Interventions

epicatechin gallate

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of cardiovascular anesthesiology and intensive care

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 18, 2021

Study Start

October 18, 2021

Primary Completion

November 9, 2022

Study Completion

November 9, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)