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Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection (ACTIV-2)

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ClinicalTrials.gov Identifier: NCT04709120
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Tamara Kriukova, Eurasian Association of Therapists

Study Description
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Brief Summary:
Comparison of COVID-19 disease course in hospitalized patients infected by SARS-CoV-2 in first and second waves of the novel coronavirus infection

Condition or disease
Covid19 Comorbidities and Coexisting Conditions Risk Factor, Cardiovascular Death Diabetes COPD Atrial Fibrillation DVT CKD

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 4 Weeks
Official Title: Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection
Actual Study Start Date : January 11, 2021
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. death [ Time Frame: 4 weeks ]
    death for any reason


Secondary Outcome Measures :
  1. Number of cases of Acute Kidney Injury depending on Coexisting Conditions [ Time Frame: 4 weeks ]
  2. Number of cases of Myocarditis and Acute Coronary Events depending on Coexisting Conditions [ Time Frame: 4 weeks ]
  3. Number of cases of Cytokine Storm depending on Coexisting Conditions [ Time Frame: 4 weeks ]
  4. Number of thrombotic and thromboembolic complications of COVID-19 depending on Coexisting Conditions [ Time Frame: 4 weeks ]
  5. Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions [ Time Frame: 4 weeks ]
  6. Rate of cases of health status worsening occured during hospitalisation [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Anonymized male and female patients over the age of 18 hospitalised since October, 1st, 2020
Criteria

Inclusion Criteria:

Suspected or confirmed COVID-19 (according to results of swab-test, antibody test, computed tomography or radiography image)

Exclusion Criteria:

  1. Unwillingness to participate in the study;
  2. Age under 18.
Contacts and Locations
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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): NCT04709120


Contacts
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Contact: Tamara Kriukova, master +79992114977 tk@euat.ru
Contact: Anastasia Ermilova +79851593410 aermilova@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 Director: Grigoriy Arutyunov, MD, PhD Eurasian Association of Therapists
Study Chair: Ekaterina Tarlovskaya, MD, PhD Eurasian Association of Therapists
Principal Investigator: Aleksander Arutyunov, MD, PhD Eurasian Association of Therapists
More Information
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Responsible Party: Tamara Kriukova, Eurasian Association of Therapists
ClinicalTrials.gov Identifier: NCT04709120    
Other Study ID Numbers: ACTIV-2
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
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
Keywords provided by Tamara Kriukova, Eurasian Association of Therapists:
Covid19
Comorbidities and Coexisting Conditions
Risk Factor
SARS-CoV-2
 COVID-19 Second Wave
COVD-19 First Wave
Death
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes