Covid19ACTIV-2NCT04709120
Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection
An observational study of Covid19 and Comorbidities and Coexisting Conditions, run by Eurasian Association of Therapists at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Comorbidities and Coexisting Conditions, Risk Factor, Cardiovascular
- How many people
- 2,968 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2020to 30 May 2021
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Anonymized male and female patients over the age of 18 hospitalised since October, 1st, 2020
Who may be able to join
- Suspected or confirmed COVID-19 (according to results of swab-test, antibody test, computed tomography or radiography image)
Who cannot join
- Unwillingness to participate in the study;
- Age under 18.
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of COVID-19 disease course in hospitalized patients infected by SARS-CoV-2 in first and second waves of the novel coronavirus infection
Read the 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.
- Conditions
- Covid19, Comorbidities and Coexisting Conditions, Risk Factor, Cardiovascular, Death, Diabetes, COPD
- Keywords
- Covid19, Comorbidities and Coexisting Conditions, Risk Factor, SARS-CoV-2, COVID-19 Second Wave, COVD-19 First Wave, Death
- Medical subject headings
- COVID-19, Death, Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
death
death for any reason
Measured: 4 weeks
Secondary outcomes (6)
Number of cases of Acute Kidney Injury depending on Coexisting Conditions
Number of cases of Acute Kidney Injury depending on Coexisting Conditions
Measured: 4 weeks
Number of cases of Myocarditis and Acute Coronary Events depending on Coexisting Conditions
Number of cases of Myocarditis and Acute Coronary Events depending on Coexisting Conditions
Measured: 4 weeks
Number of cases of Cytokine Storm depending on Coexisting Conditions
Number of cases of Cytokine Storm depending on Coexisting Conditions
Measured: 4 weeks
Number of thrombotic and thromboembolic complications of COVID-19 depending on Coexisting Conditions
Number of thrombotic and thromboembolic complications of COVID-19 depending on Coexisting Conditions
Measured: 4 weeks
Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions
Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions
Measured: 4 weeks
Rate of cases of health status worsening occured during hospitalisation
Rate of cases of health status worsening occured during hospitalisation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Oct 2020
- Primary completion30 Mar 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,968 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Eurasian Association of Therapists
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Kriukova, Eurasian Association of Therapists
- Investigators
- Grigoriy Arutyunov, MD, PhD, Study director, Eurasian Association of TherapistsEkaterina Tarlovskaya, MD, PhD, Study chair, Eurasian Association of TherapistsAleksander Arutyunov, MD, PhD, Principal investigator, Eurasian Association of Therapists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709120
- Sponsor's protocol ID
- ACTIV-2
- Acronym
- ACTIV-2
- Status last verified
- Sep 2023
- First submitted
- 13 Jan 2021
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04709120
- Acronym / sponsor ID
- ACTIV-2 / ACTIV-2
- Conditions
- Covid19, Comorbidities and Coexisting Conditions, Risk Factor, Cardiovascular, Death, Diabetes, COPD
- Keywords
- Covid19, Comorbidities and Coexisting Conditions, Risk Factor, SARS-CoV-2, COVID-19 Second Wave, COVD-19 First Wave, Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,968 participants (actual)
- Lead sponsor
- Eurasian Association of TherapistsUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of COVID-19 disease course in hospitalized patients infected by SARS-CoV-2 in first and second waves of the novel coronavirus infection
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Anonymized male and female patients over the age of 18 hospitalised since October, 1st, 2020
Key inclusion criteria (1 listed)
- Suspected or confirmed COVID-19 (according to results of swab-test, antibody test, computed tomography or radiography image)
Key exclusion criteria (2 listed)
- Unwillingness to participate in the study;
- Age under 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
death
Time frame: 4 weeks
death for any reason
6 secondary outcomes
Number of cases of Acute Kidney Injury depending on Coexisting Conditions
Time frame: 4 weeks
Number of cases of Myocarditis and Acute Coronary Events depending on Coexisting Conditions
Time frame: 4 weeks
Number of cases of Cytokine Storm depending on Coexisting Conditions
Time frame: 4 weeks
Number of thrombotic and thromboembolic complications of COVID-19 depending on Coexisting Conditions
Time frame: 4 weeks
Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions
Time frame: 4 weeks
Rate of cases of health status worsening occured during hospitalisation
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- 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"Link provided by the sponsor.
- 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"Link provided by the sponsor.
- 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"Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grigoriy Arutyunov, MD, PhD study director
Eurasian Association of Therapists
Ekaterina Tarlovskaya, MD, PhD study chair
Eurasian Association of Therapists
Aleksander Arutyunov, MD, PhD principal investigator
Eurasian Association of Therapists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Comorbidities and Coexisting Conditions, run by Eurasian Association of Therapists at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.