COVID-19ACTIV4NCT05226416
Analysis of Health Status of Сomorbid Adult Patients With COVID-19 Hospitalised in Fourth Wave of SARS-CoV-2 Infection
An observational study of COVID-19 and Chronic Heart Failure, run by Eurasian Association of Therapists at 1 site in Russia.
Trial summary
Depersonalized multi-centered registry initiated to analyze dynamics of non-infectious diseases after SARS-CoV-2 infection in population of Eurasian adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Chronic Heart Failure, Diabetes Mellitus
- How many people
- 3,554 participants
- Where
- 1 siteRussia
- Study dates
- 21 Feb 2022to 21 Apr 2023
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Anonymized male and female patients over 18 years hospitalized with COVID-19 during the fourth wave of novel coronavirus disease.
Who may be able to join
- Suspected or confirmed COVID-19
Who cannot join
- Age under 18 years.
- Refusal to be involved in study;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Health Status of Сomorbid Adult Patients With COVID-19 Hospitalised in Fourth Wave of SARS-CoV-2 Infection (ACTIV4)
Depersonalized multi-centered registry initiated to analyze dynamics of non-infectious diseases after SARS-CoV-2 infection in population of Eurasian adult patients.
Read the detailed description
Assessment of hospital course and health status during 3, 6, 12 months after discharge in COVID-19 patients in cohorts with comorbidities and without comorbidities. Evaluation of comorbidity impact to severity of novel coronavirus disease and comorbidity impact to demand for medical care.
- Conditions
- COVID-19, Chronic Heart Failure, Diabetes Mellitus, Chronic Kidney Diseases, Ischemic Heart Disease, Arrythmia
- Keywords
- covid-19, ACTIV, Chronic Heart Failure, Ischemic Heart Disease, Hypertensive Heart Disease, Chronic Kidney Diseases, Atrial Fibrillation, Myocarditis
- Medical subject headings
- COVID-19, Diabetes Mellitus, Renal Insufficiency, Chronic, Myocardial Ischemia, Arrhythmias, Cardiac, Overweight, Obesity, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
death for any cause
rate of lethal outcomes
Measured: From date of hospitalization until the date of first documented date of death from any cause, assessed up to 12 months
hospitalization for any cause
rate of hospitalization for any cause
Measured: 12 months after discharge
Secondary outcomes (2)
onset of any disease diagnosed 1 year after discharge
rate of patients with onset of any disease diagnosed 1 year after discharge
Measured: 1 year after discharge
rate of demand for medical care
number of patients seeking for health care after discharge
Measured: 1 year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start21 Feb 2022
- Primary completion31 Mar 2022
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Prospective
- Enrolment
- 3,554 participants (actual)
- Target duration
- 1 Year
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
- Alexander Arutyunov, MD, PhD, Principal investigator, Eurasian Association of Therapists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226416
- Sponsor's protocol ID
- ACTIV4
- Acronym
- ACTIV4
- Status last verified
- May 2023
- First submitted
- 1 Feb 2022
- Last updated
- 9 May 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Health Status of Сomorbid Adult Patients With COVID-19 Hospitalised in Fourth Wave of SARS-CoV-2 Infection (ACTIV4)
- ClinicalTrials.gov ID
- NCT05226416
- Acronym / sponsor ID
- ACTIV4 / ACTIV4
- Conditions
- COVID-19, Chronic Heart Failure, Diabetes Mellitus, Chronic Kidney Diseases, Ischemic Heart Disease, Arrythmia
- Keywords
- covid-19, ACTIV, Chronic Heart Failure, Ischemic Heart Disease, Hypertensive Heart Disease, Chronic Kidney Diseases, Atrial Fibrillation, Myocarditis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,554 participants (actual)
- Lead sponsor
- Eurasian Association of TherapistsUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 7 Feb 2022 (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.
Depersonalized multi-centered registry initiated to analyze dynamics of non-infectious diseases after SARS-CoV-2 infection in population of Eurasian adult patients.
Detailed description
Assessment of hospital course and health status during 3, 6, 12 months after discharge in COVID-19 patients in cohorts with comorbidities and without comorbidities. Evaluation of comorbidity impact to severity of novel coronavirus disease and comorbidity impact to demand for medical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Anonymized male and female patients over 18 years hospitalized with COVID-19 during the fourth wave of novel coronavirus disease.
Key inclusion criteria (1 listed)
- Suspected or confirmed COVID-19
Key exclusion criteria (2 listed)
- Age under 18 years.
- Refusal to be involved in study;
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 for any cause
Time frame: From date of hospitalization until the date of first documented date of death from any cause, assessed up to 12 months
rate of lethal outcomes
hospitalization for any cause
Time frame: 12 months after discharge
rate of hospitalization for any cause
2 secondary outcomes
onset of any disease diagnosed 1 year after discharge
Time frame: 1 year after discharge
rate of demand for medical care
Time frame: 1 year after discharge
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 9 May 2023.
- 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.
Alexander 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 COVID-19 and Chronic Heart Failure, 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 9 May 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 for any cause (time frame: From date of hospitalization until the date of first documented date of death from any cause, assessed up to 12 months). The study lists 2 primary outcomes in all. 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 9 May 2023.