Covid-19 Associated Coagulopathy Predicted by Thrombodynamic Markers (CoViTro-I)
1 other identifier
observational
2,200
1 country
1
Brief Summary
The aim of the study is estimating the predictive and preventative capability of thrombodynamics for severe pneumonia coagulopathy complications in patients with COVID-19 infection. Thrombodynamics test is a method for blood coagulation and anticoagulation monitoring. It could be a useful tool for predicting thrombohemorrhagic complications in patients with COVID-19 infection and developing a novel scheme of anticoagulant therapy. Inclusion criteria are the following: patient informed concern, confirmed COVID-19 diagnosis, state of modern or critical condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedFirst Submitted
Initial submission to the registry
February 22, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2022
CompletedApril 15, 2022
January 1, 2022
9 months
February 22, 2022
April 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
OS
Outcome Measure - In-hospital mortality rate
From study enrollment until the date of death from any cause, assessed up to 4 months
Secondary Outcomes (7)
Myocardial infarction
4 months from study enrollment
Ischemic stroke
4 months from study enrollment
Arterial thrombosis
4 months from study enrollment
Venous thromboembolism,
4 months from study enrollment
DVT
4 months from study enrollment
- +2 more secondary outcomes
Study Arms (1)
Patients with confirmed SARS-Cov-2 infection
Hospitalized patients with modern or critical condition with confirmed COVID-19 infection. Patients received standard therapy for COVID-19 infection and anticoagulant prophylaxis if needed according to current temporary clinical recommendations.
Interventions
Thrombodynamics test is a global hemostasis test that allows to register the dynamics of fibrin clot formation in time and space. It requires whole blood samples from included patients.
Eligibility Criteria
Study population consists of hospitalized patients with confirmed COVID-19 infection from April till December 2020 from 5 Moscow hospitals #40, 51, 23, 64 and the Troitsk hospital.
You may qualify if:
- Patient (or the health care surrogate) Informed consent
- Confirmed COVID-19 diagnosis
You may not qualify if:
- \) Patient (or the health care surrogate) refusal to participate in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology
Moscow, Russia
Biospecimen
Whole blood (Ailiton, UNIVAC plastic tubes, 4,5 mL with Sodium citrate 3,2%)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2022
First Posted
April 15, 2022
Study Start
April 1, 2020
Primary Completion
December 15, 2020
Study Completion
April 21, 2022
Last Updated
April 15, 2022
Record last verified: 2022-01