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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04492384
Other study ID # ACTIV11062020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 29, 2020
Est. completion date November 29, 2021

Study information

Verified date September 2023
Source Eurasian Association of Therapists
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 infection in adults.


Description:

Non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 infection in cohort of Russian adult patients. Retrospective analysis of medical histories and outcomes in adults with pre-existing conditions after SARS-CoV-2 infection and prospective monitoring of health status during 3, 6 and 12 months after discharge. Comorbidities worsening risk factors measuring through evaluation of range of indicators such as dynamics of diabetes, CKD, COPD, bronchial astma, incidence of hypertonic crises, vascular events and others.


Recruitment information / eligibility

Status Completed
Enrollment 6396
Est. completion date November 29, 2021
Est. primary completion date November 29, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Suspected or confirmed COVID-19. Exclusion Criteria: - Refuse to be involved in study; - Age under 18 years.

Study Design


Intervention

Other:
non-interventional
Interview on health conditions

Locations

Country Name City State
Russian Federation Eurasian Association of Therapists Moscow

Sponsors (1)

Lead Sponsor Collaborator
Eurasian Association of Therapists

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary rate of non-infectious diseases percentage of patients with non-infectious diseases relating to overall number of patients registered in study 12 month since a moment of request of medical help
Primary severity of COVID-19 depending on pre-existing diseases correlation between number of patients with COVID-19 of various severity and number of pre-existing conditions and their severity among these groups 12 month since a moment of request of medical help
Primary disability registration / change of disability status Registration of disability or change of disability status 12 month since a moment of request of medical help
Primary rate of letal outcomes rate of deaths among registered participants 12 month since a moment of request of medical help
Primary rate of letal outcomes depending on pre-existing disease correlation between number of deaths and pre-existing diseases 12 month since a moment of request of medical help
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