NCT04752085

Brief Summary

The aim of the cohort prospective observational study is to define the major factors influencing the course of COVID-19 infections and its prognosis in hospitalised patients. The investigators plan to include 300 patients hospitalised with COVID-19 infection. The phone contacts with patients are due after 90 and 180 days after discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
345

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

November 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

February 9, 2021

Last Update Submit

January 24, 2023

Conditions

Keywords

COVID-19chitotriosidaseSARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

  • Need in biological therapy or/and respiratory support

    The primary endpoint is the need in biological therapy or/and respiratory support including noninvasive ventilation during hospital stay

    Up to 1 month

Secondary Outcomes (3)

  • Number of days spent in hospital

    Up to 1 month

  • All-cause death

    90 days

  • All-cause death

    180 days

Interventions

The chitotriosidase activity will be measured in all the subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

300 patients hospitalised with COVID-19 infection

You may qualify if:

  • Hospitalisation with COVID-19

You may not qualify if:

  • History of hospitalisation with COVID-19 infection
  • Discharge from the hospital before the end of the treatment course
  • Transfer to another hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital #1

Moscow, Russia

Location

University Hospital #4

Moscow, Russia

Location

Related Publications (1)

  • Schelkanovtseva ES, Isaev GO, Mironova OY, Balakhonov AA, Skvortsov AV, Nagornov IO, Suvorov AY, Fomin VV, Panferov AS. [The survival prediction of hospitalized patients with COVID-19: the role of chitotriosidase level in peripheral blood]. Ter Arkh. 2023 Sep 29;95(7):543-547. doi: 10.26442/00403660.2023.07.202280. Russian.

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Olga Mironova, PhD

    Sechenov University

    PRINCIPAL INVESTIGATOR
  • Ekaterina Schelkanovtseva, MD

    Sechenov University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 12, 2021

Study Start

November 1, 2020

Primary Completion

March 1, 2021

Study Completion

January 10, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations