ACTIV4: Analysis of Health Status of Сomorbid Adult Patients With COVID-19 Hospitalised in Fourth Wave of SARS-CoV-2 Infection
Sponsor
Eurasian Association of Therapists (Other)
Overall Status
Recruiting
CT.gov ID
NCT05226416
Collaborator
(none)
4,500
1
11.3
397
Study Details
Study Description
Brief Summary
Depersonalized multi-centered registry initiated to analyze dynamics of non-infectious diseases after SARS-CoV-2 infection in population of Eurasian adult patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
4500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Analysis of Health Status of Сomorbid Adult Patients With COVID-19 Hospitalised in Fourth Wave of SARS-CoV-2 Infection (ACTIV4)
Actual Study Start Date
:
Feb 21, 2022
Anticipated Primary Completion Date
:
Feb 1, 2023
Anticipated Study Completion Date
:
Feb 1, 2023
Outcome Measures
Primary Outcome Measures
- death for any cause [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 [12 months after discharge]
rate of hospitalization for any cause
Secondary Outcome Measures
- onset of any disease diagnosed 1 year after discharge [1 year after discharge]
rate of patients with onset of any disease diagnosed 1 year after discharge
- rate of demand for medical care [1 year after discharge]
number of patients seeking for health care after discharge
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Suspected or confirmed COVID-19
Exclusion Criteria:
-
Age under 18 years.
-
Refusal to be involved in study;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eurasian Association of Therapists | Moscow | Russian Federation | 101000 |
Sponsors and Collaborators
- Eurasian Association of Therapists
Investigators
- Principal Investigator: Alexander Arutyunov, MD, PhD, Eurasian Association of Therapists
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Tamara Kriukova,
Head of Organizational Committee,
Eurasian Association of Therapists
ClinicalTrials.gov Identifier:
NCT05226416
Other Study ID Numbers:
- ACTIV4
First Posted:
Feb 7, 2022
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tamara Kriukova,
Head of Organizational Committee,
Eurasian Association of Therapists
Additional relevant MeSH terms: