Prognosis and Course of COVID-19 Infection in Hospitalised Patients

Covid19 Clinical Trial

Official title:

Prognosis and Course of COVID-19 Infection in Hospitalised Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752085
• Other study ID #: 03-21
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: January 10, 2023

Study information

• Verified date: January 2023
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: January 10, 2023
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Covid19
• Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• Chitotriosidase activity
The chitotriosidase activity will be measured in all the subjects

Locations

Country	Name	City	State
Russian Federation	University Hospital #1	Moscow
Russian Federation	University Hospital #4	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

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

External Links

•   Chitotriosidase Activity in Lung Injury Associated with Coronavirus Disease 2019 (COVID-19)