Prognosis and Course of COVID-19 Infection in Hospitalised Patients

January 24, 2023 updated by: Olga Mironova, I.M. Sechenov First Moscow State Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

345

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • University hospital #1
      • Moscow, Russian Federation
        • University Hospital #4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

300 patients hospitalised with COVID-19 infection

Description

Inclusion Criteria:

  • Hospitalisation with COVID-19

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need in biological therapy or/and respiratory support
Time Frame: Up to 1 month
The primary endpoint is the need in biological therapy or/and respiratory support including noninvasive ventilation during hospital stay
Up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days spent in hospital
Time Frame: Up to 1 month
The investigators plan to assess the overall length of hospitalisation due to COVID-19 infection as an outcome measure
Up to 1 month
All-cause death
Time Frame: 90 days
To assess the all-cause death 90 days after discharge
90 days
All-cause death
Time Frame: 180 days
To assess the all-cause death 180 days after discharge
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Investigators

  • Principal Investigator: Olga Mironova, PhD, Sechenov University
  • Study Chair: Ekaterina Schelkanovtseva, MD, Sechenov University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

January 10, 2023

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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