SARS-COV2 InfectionNCT04787510
COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection
An observational study of SARS-COV2 Infection and COVID-19 Disease, run by University Hospital, Ioannina at 1 site in Greece.
Trial summary
Effect of Covid-19 disease in clotting factors levels in hospitalized patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-COV2 Infection, COVID-19 Disease, Hospitalized Patients
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 23 Dec 2020to 23 Jun 2021
- How long will I take part?
- 6 Months
- 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: ALL ELIGIBLE PATIENTS AS DEFINED BY CRITERIA
Who may be able to join
- AGE> 18
- SINGED INFORMED CONSENT FORM
- POSITIVE PCR TEST FOR SARS-COV2 INFECTION
- FINDINGS IN CXR OR CT OF THE LUNGS CONSISTENT WITH INFECTION OF LOWER RESPIRATORY TRACT
Who cannot join
- AGE<18
- DENIAL TO PROVIDE INFORMED CONSENT FORM
- HISTORY OF MALIGNANCY
- PRIOR USE OF ANTICOAGULANT THERAPY
- PRIOR USE OF STEROIDS LONGER THAN 14 DAYS
- LACTATION-PREGNANCY
Trial locations and contacts
1 site in 1 country.
About this study
Effect of Covid-19 disease in clotting factors levels in hospitalized patients
Read the detailed description
Effect of Covid-19 disease in clotting factors levels in hospitalized patients positive for sars-cov2 infection.
Association between clotting factors levels and disease severity,morbidity and mortality in these patients.
Effect of anticoagulant therapy in the clotting factors' levels in these patients
- Conditions
- SARS-COV2 Infection, COVID-19 Disease, Hospitalized Patients
- Being tested
- low molecular weight Heparin as standard of care treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low molecular weight Heparin as standard of care treatmentDrug
STANDARD OF CARE
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFECT OF COVID-19 DISEASE IN CLOTTING FACTORS
leves of cloting factors before and after treatment with LMWH
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start23 Dec 2020
- Primary completion23 May 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-COV2 InfectionStudies 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
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Ioannina
- Sponsor type
- University, hospital or other
- Collaborators
- INTERNAL MEDICINE DEPARTMENT, 1ST WARD
- Responsible party
- Principal investigator, Liontos Angelos, University Hospital, Ioannina
- Investigators
- HARALAMPOS MILIONIS, PROFESSOR, Principal investigator, University Hospital, Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787510
- Sponsor's protocol ID
- 895/23-12-2020
- Status last verified
- Sep 2021
- First submitted
- 4 Mar 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04787510
- Acronym / sponsor ID
- 895/23-12-2020
- Conditions
- SARS-COV2 Infection, COVID-19 Disease, Hospitalized Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, IoanninaUniversity, hospital or other
- Collaborators
- INTERNAL MEDICINE DEPARTMENT, 1ST WARD
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 23 May 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 8 Mar 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.
Effect of Covid-19 disease in clotting factors levels in hospitalized patients
Detailed description
Effect of Covid-19 disease in clotting factors levels in hospitalized patients positive for sars-cov2 infection.
Association between clotting factors levels and disease severity,morbidity and mortality in these patients.
Effect of anticoagulant therapy in the clotting factors' levels in these patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ALL ELIGIBLE PATIENTS AS DEFINED BY CRITERIA
Key inclusion criteria (4 listed)
- AGE> 18
- SINGED INFORMED CONSENT FORM
- POSITIVE PCR TEST FOR SARS-COV2 INFECTION
- FINDINGS IN CXR OR CT OF THE LUNGS CONSISTENT WITH INFECTION OF LOWER RESPIRATORY TRACT
Key exclusion criteria (6 listed)
- AGE<18
- DENIAL TO PROVIDE INFORMED CONSENT FORM
- HISTORY OF MALIGNANCY
- PRIOR USE OF ANTICOAGULANT THERAPY
- PRIOR USE OF STEROIDS LONGER THAN 14 DAYS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low molecular weight Heparin as standard of care treatmentSTANDARD OF CARE | Drug | – |
Primary outcome
EFFECT OF COVID-19 DISEASE IN CLOTTING FACTORS
Time frame: 6 MONTHS
leves of cloting factors before and after treatment with LMWH
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 28 Sep 2021.
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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.
HARALAMPOS MILIONIS, PROFESSOR principal investigator
University Hospital, Ioannina
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 SARS-COV2 Infection and COVID-19 Disease, run by University Hospital, Ioannina at 1 site in Greece.
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 4 inclusion and 6 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 28 Sep 2021. 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 Greece. 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?
EFFECT OF COVID-19 DISEASE IN CLOTTING FACTORS (time frame: 6 MONTHS). 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 28 Sep 2021.