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Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients (ACTIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04492384
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Tamara Kriukova, Eurasian Association of Therapists

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

Condition or disease Intervention/treatment
Covid19 SARS-CoV-2 Infection Pneumonia Copd CKD Cardiac Event Overweight and Obesity Cardiovascular Diseases Diabetes Hypertension Coronary Heart Disease Other: non-interventional

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients
Actual Study Start Date : June 11, 2020
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : January 15, 2022

Group/Cohort Intervention/treatment
inpatients
Patients treated from COVID-19 in hospital
Other: non-interventional
Interview on health conditions

outpatients
Patients treated from COVID-19 at home
Other: non-interventional
Interview on health conditions




Primary Outcome Measures :
  1. rate of non-infectious diseases [ Time Frame: 12 month since a moment of request of medical help ]
    percentage of patients with non-infectious diseases relating to overall number of patients registered in study

  2. severity of COVID-19 depending on pre-existing diseases [ Time Frame: 12 month since a moment of request of medical help ]
    correlation between number of patients with COVID-19 of various severity and number of pre-existing conditions and their severity among these groups

  3. disability registration / change of disability status [ Time Frame: 12 month since a moment of request of medical help ]
    Registration of disability or change of disability status

  4. rate of letal outcomes [ Time Frame: 12 month since a moment of request of medical help ]
    rate of deaths among registered participants

  5. rate of letal outcomes depending on pre-existing disease [ Time Frame: 12 month since a moment of request of medical help ]
    correlation between number of deaths and pre-existing diseases



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Anonymized male and female patients over 18 years infected COVID-19 recieved inpatient or outpatient care
Criteria

Inclusion Criteria:

  • Suspected or confirmed COVID-19.

Exclusion Criteria:

  • Refuse to be involved in study;
  • Age under 18 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492384


Contacts
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Contact: Tamara Kriukova, master +79992114977 tk@euat.ru
Contact: Anastasia Rud, master +79263639827 manager@euat.ru

Locations
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Russian Federation
Eurasian Association of Therapists Recruiting
Moscow, Russian Federation, 101000
Contact: Tamara Kriukova    +79992114977    tk@euat.ru   
Contact: Anastasia Rud    +79263639827    rud@euat.ru   
Sponsors and Collaborators
Eurasian Association of Therapists
Investigators
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Study Chair: Alexander Arutyunov, professor Eurasian Association of Therapists
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Responsible Party: Tamara Kriukova, Head of Organizational Committee, Eurasian Association of Therapists
ClinicalTrials.gov Identifier: NCT04492384    
Other Study ID Numbers: ACTIV11062020
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Overweight
Noncommunicable Diseases
Vascular Diseases
Body Weight
Myocardial Ischemia
Chronic Disease
Disease Attributes
Pathologic Processes