NCT04709120

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,968

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

January 13, 2021

Last Update Submit

September 6, 2023

Conditions

Keywords

Covid19Comorbidities and Coexisting ConditionsRisk FactorSARS-CoV-2COVID-19 Second WaveCOVD-19 First WaveDeath

Outcome Measures

Primary Outcomes (1)

  • death

    death for any reason

    4 weeks

Secondary Outcomes (6)

  • 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

    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

    4 weeks

  • Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions

    4 weeks

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Anonymized male and female patients over the age of 18 hospitalised since October, 1st, 2020

You may qualify if:

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

You may not qualify if:

  • Unwillingness to participate in the study;
  • Age under 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurasian Association of Therapists

Moscow, 101000, Russia

Location

Related Links

MeSH Terms

Conditions

COVID-19DeathDiabetes MellitusPulmonary Disease, Chronic ObstructiveAtrial Fibrillation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesArrhythmias, CardiacHeart DiseasesCardiovascular Diseases

Study Officials

  • Grigoriy Arutyunov, MD, PhD

    Eurasian Association of Therapists

    STUDY DIRECTOR
  • Ekaterina Tarlovskaya, MD, PhD

    Eurasian Association of Therapists

    STUDY CHAIR
  • Aleksander Arutyunov, MD, PhD

    Eurasian Association of Therapists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eurasian Association of Therapists

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 14, 2021

Study Start

October 1, 2020

Primary Completion

March 30, 2021

Study Completion

May 30, 2021

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations