- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04709120
Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection (ACTIV-2)
Study Overview
Status
Detailed Description
Non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 in first and second waves of the novel coronavirus 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. 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Moscow, Russian Federation, 101000
- Eurasian Association of Therapists
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Suspected or confirmed COVID-19 (according to results of swab-test, antibody test, computed tomography or radiography image)
Exclusion Criteria:
- Unwillingness to participate in the study;
- Age under 18.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
death
Time Frame: 4 weeks
|
death for any reason
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of cases of Acute Kidney Injury depending on Coexisting Conditions
Time Frame: 4 weeks
|
Number of cases of Acute Kidney Injury depending on Coexisting Conditions
|
4 weeks
|
Number of cases of Myocarditis and Acute Coronary Events depending on Coexisting Conditions
Time Frame: 4 weeks
|
Number of cases of Myocarditis and Acute Coronary Events depending on Coexisting Conditions
|
4 weeks
|
Number of cases of Cytokine Storm depending on Coexisting Conditions
Time Frame: 4 weeks
|
Number of cases of Cytokine Storm depending on Coexisting Conditions
|
4 weeks
|
Number of thrombotic and thromboembolic complications of COVID-19 depending on Coexisting Conditions
Time Frame: 4 weeks
|
Number of thrombotic and thromboembolic complications of COVID-19 depending on Coexisting Conditions
|
4 weeks
|
Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions
Time Frame: 4 weeks
|
Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions
|
4 weeks
|
Rate of cases of health status worsening occured during hospitalisation
Time Frame: 4 weeks
|
Rate of cases of health status worsening occured during hospitalisation
|
4 weeks
|
Collaborators and Investigators
Investigators
- 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
Publications and helpful links
Helpful Links
- design of observational studies "Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients" and "Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection"
- Lipid profile in hospitalized patients with COVID-19 depending on the outcome of its acute phase: data from the international registry "Dynamics analysis of comorbidities in SARS-CoV-2 infection survivors"
- Impact of Kidney Damage on the Course and Prognosis of COVID-19 Infection According to the International Registry "Analysis of Chronic Non-Infectious Diseases Dynamics After Covid-19 Infection in Adult Patients"
- The impact of carbohydrate metabolism disorders on the early and long-term clinical outcomes of patients with COVID-19 according to the AKTIV and AKTIV 2 registries.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Arrhythmias, Cardiac
- COVID-19
- Atrial Fibrillation
Other Study ID Numbers
- ACTIV-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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