COVID-19 PatientsNCT05083104
Assessment of the Natural Anticoagulant Profile in Patients With COVID-19
An observational study of COVID-19 Patients, run by Sohag University.
Trial summary
At the beginning of 2020, coronavirus disease 19 (COVID-19) was declared a pandemic of international concern and an unprecedented challenge for country-specific health care systems . Read more about this study
- Who is it for?
- Ages 5 to 50 years
- Conditions the study is for
- COVID-19 Patients
- What is being tested?
- laboratory investigations on coagulation profiles
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 30 Dec 2022
- 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 5 to 50 years
- All sexes
- Child, Adult
Study population: Group (I): represents the healthy control individuals Group (II): represents the mild and severe cases of COVID 19 patients.
Who may be able to join
- This study will be conducted on a group of patients who are diagnosed as COVID-19 by PCR, a group of them have mild symptoms and another group admitted in ICU (critically ill patients).
Who cannot join
- Any clinical condition cause hypercoagulability state such as:
- Pregnancy.
- Recent trauma or surgery.
- Prolonged bed rest or immobility.
- Cancer or its medications, such as tamoxifen, bevacizumab, thalidomide and lenalidomide.
- Hormone replacement therapy.
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- Heparin-induced thrombocytopenia (decreased platelets in the blood due to heparin or low molecular weight heparin preparations).
- Previous history of deep vein thrombosis or pulmonary embolism.
- Myeloproliferative disorders such as polycythemia vera or essential thrombocytosis.
About this study
At the beginning of 2020, coronavirus disease 19 (COVID-19) was declared a pandemic of international concern and an unprecedented challenge for country-specific health care systems . Patients infected with COVID-19 develop from mild, self-limiting respiratory tract illness to severe progressive pneumonia associated with multi-organ failure . In particular, COVID-19 has been shown to exert significant effects on the hematopoietic system and hemostasis
Read the detailed description
At the beginning of 2020, coronavirus disease 19 (COVID-19) was declared a pandemic of international concern and an unprecedented challenge for country-specific health care systems. The clinical feature of the disease is very wide and ranges from minor unspecified symptoms (such as fever, dry cough, and diarrhea) to severe pneumonia, lung insufficiency, and death. Fall in respiratory insufficiency needing mechanical ventilation, or in multiple organ failure occurs in 5% of the infected patients, mainly according to age and comorbidities. Coronaviruses are important pathogens in humans that can cause diseases ranging from the common cold to more severe and even fatal respiratory infections. Since the outbreak of the novel COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in December 2019 in Wuhan, China, more than 2 million cases have been diagnosed globally to date and the number is still growing rapidly . Patients infected with COVID-19 develop from mild, self-limiting respiratory tract illness to severe progressive pneumonia associated with multi-organ failure .
Most of the people who contracted COVID-19 presented with mild symptoms (80.9%), then severe (13.8%), and finally critical (4.7%). Most of the confirmed cases were between the ages of 30 and 70 (86.6%), diagnosed in Hubei (74.7%), with an overall fatality rate of 2.3%, and 0.3% in health workers. The case fatality rate for critical cases was 49.0%. Patients with underlying diseases had much higher fatality rates than patients with no underlying diseases (10.5% for cardiovascular disease, 7.3% for diabetes, 6.3% for chronic respiratory disease, 6.0% for hypertension, 5.6% for cancer, and 0.9% for none).
In clinical practice, coagulation dysfunction is commonly found in COVID-19 patients, and the symptoms range from mild disorders of coagulation indicators to disseminated intravascular coagulation (DIC). The exact etiology of COVID-19-associated coagulopathy is unclear, diverse and multifactorial, and may include direct attack by the SARS-CoV-2 on vascular endothelial cells, cytokine storm-mediated inflammation-coagulation cascades, hypoxia, and complication with sepsis. Coagulation dysfunction or thrombocytopenia is closely associated with the severity and poor prognosis in COVID-19 patients .
Recently, coagulopathy was reported widely present in severe SARS-CoV-2 infected patients, and disseminated intravascular coagulation (DIC) developed in the majority of non-survivors . In particular, COVID-19 has been shown to exert significant effects on the hematopoietic system and hemostasis . Studies have emphasized that patients diagnosed with COVID-19 are susceptible to hypercoagulation and thrombotic events. Microvascular thrombosis has been observed in autopsies performed on patients .
Recent observations suggest that respiratory failure in coronavirus disease 2019 (COVID 19) infections are not caused by the development of the acute respiratory distress syndrome (ARDS) alone, but that microvascular thrombotic processes may contribute, also. One of the most significant poor prognostic signs in those patients is the development of coagulopathy .
- Conditions
- COVID-19 Patients
- Being tested
- laboratory investigations on coagulation profiles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory investigations on coagulation profilesDiagnostic test
CBC ,PT ,aPTT ,Protein C .Protein S ,ATIII and vWF
| Study group | Role | What they receive |
|---|---|---|
| age and sex matched healthy control individuals. | controls divided into groups ,each group match in age and sex with cases Receives: Diagnostic Test: laboratory investigations on coagulation profiles | |
| mild and severe cases of COVID 19 patients | Covid 19 cases diagnosed by PCR , mild cases have symptoms as fever, dry cough, and diarrhea and severe cases admitted in ICU Receives: Diagnostic Test: laboratory investigations on coagulation profiles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect of COVID-19 disease on coagulation cascade in patients of this disease.
The study will be conducted on a group of patients who are diagnosed as COVID-19 by PCR, All patients and controls were subjected to Full history taking ,clinical examination
Measured: within the same day of collection of samples
Assess the effect of COVID-19 disease on coagulation cascade in patients of this disease.
The study will be conducted on a group of patients who are diagnosed as COVID-19 by PCR, and All patients and controls were subjected to Laboratory investigations as Complete blood count with platelet indices (MPV measured by fL \& PDW measured by fL) ,
Measured: within the same day of collection of samples
Assess the effect of COVID-19 disease on coagulation cascade in patients of this disease.
The study will be conducted on a group of patients who are diagnosed as COVID-19 by PCR, and All patients and controls were subjected to Laboratory investigations as Prothrombin time PT measured by seconds and activated partial thromboplastin time aPTT measured by seconds
Measured: within the same day of collection of samples
Assess the effect of COVID-19 disease on coagulation cascade in patients of this disease.
The study will be conducted on a group of patients who are diagnosed as COVID-19 by PCR, and All patients and controls were subjected to Laboratory investigations as Protein C measured by %, Protein S measured by %, and Antithrombin III measured by %.
Measured: within the same day of collection of samples
Assess the effect of COVID-19 disease on coagulation cascade in patients of this disease.
The study will be conducted on a group of patients who are diagnosed as COVID-19 by PCR, and All patients and controls were subjected to Laboratory investigations as von Willebrand factor vWF measured by IU per dL.
Measured: within the same day of collection of samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PatientsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Yousry Rageh, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083104
- Sponsor's protocol ID
- Soh-Med-21-10-09
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Natural Anticoagulant Profile in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05083104
- Acronym / sponsor ID
- Soh-Med-21-10-09
- Conditions
- COVID-19 Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 19 Oct 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.
At the beginning of 2020, coronavirus disease 19 (COVID-19) was declared a pandemic of international concern and an unprecedented challenge for country-specific health care systems . Patients infected with COVID-19 develop from mild, self-limiting respiratory tract illness to severe progressive pneumonia associated with multi-organ failure . In particular, COVID-19 has been shown to exert significant effects on the hematopoietic system and hemostasis
Detailed description
At the beginning of 2020, coronavirus disease 19 (COVID-19) was declared a pandemic of international concern and an unprecedented challenge for country-specific health care systems. The clinical feature of the disease is very wide and ranges from minor unspecified symptoms (such as fever, dry cough, and diarrhea) to severe pneumonia, lung insufficiency, and death. Fall in respiratory insufficiency needing mechanical ventilation, or in multiple organ failure occurs in 5% of the infected patients, mainly according to age and comorbidities. Coronaviruses are important pathogens in humans that can cause diseases ranging from the common cold to more severe and even fatal respiratory infections. Since the outbreak of the novel COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in December 2019 in Wuhan, China, more than 2 million cases have been diagnosed globally to date and the number is still growing rapidly . Patients infected with COVID-19 develop from mild, self-limiting respiratory tract illness to severe progressive pneumonia associated with multi-organ failure .
Most of the people who contracted COVID-19 presented with mild symptoms (80.9%), then severe (13.8%), and finally critical (4.7%). Most of the confirmed cases were between the ages of 30 and 70 (86.6%), diagnosed in Hubei (74.7%), with an overall fatality rate of 2.3%, and 0.3% in health workers. The case fatality rate for critical cases was 49.0%. Patients with underlying diseases had much higher fatality rates than patients with no underlying diseases (10.5% for cardiovascular disease, 7.3% for diabetes, 6.3% for chronic respiratory disease, 6.0% for hypertension, 5.6% for cancer, and 0.9% for none).
In clinical practice, coagulation dysfunction is commonly found in COVID-19 patients, and the symptoms range from mild disorders of coagulation indicators to disseminated intravascular coagulation (DIC). The exact etiology of COVID-19-associated coagulopathy is unclear, diverse and multifactorial, and may include direct attack by the SARS-CoV-2 on vascular endothelial cells, cytokine storm-mediated inflammation-coagulation cascades, hypoxia, and complication with sepsis. Coagulation dysfunction or thrombocytopenia is closely associated with the severity and poor prognosis in COVID-19 patients .
Recently, coagulopathy was reported widely present in severe SARS-CoV-2 infected patients, and disseminated intravascular coagulation (DIC) developed in the majority of non-survivors . In particular, COVID-19 has been shown to exert significant effects on the hematopoietic system and hemostasis . Studies have emphasized that patients diagnosed with COVID-19 are susceptible to hypercoagulation and thrombotic events. Microvascular thrombosis has been observed in autopsies performed on patients .
Recent observations suggest that respiratory failure in coronavirus disease 2019 (COVID 19) infections are not caused by the development of the acute respiratory distress syndrome (ARDS) alone, but that microvascular thrombotic processes may contribute, also. One of the most significant poor prognostic signs in those patients is the development of coagulopathy .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| age and sex matched healthy control individuals. | – | Diagnostic Test: laboratory investigations on coagulation profilescontrols divided into groups ,each group match in age and sex with cases |
| mild and severe cases of COVID 19 patients | – | Diagnostic Test: laboratory investigations on coagulation profilesCovid 19 cases diagnosed by PCR , mild cases have symptoms as fever, dry cough, and diarrhea and severe cases admitted in ICU |
Who may qualify
- Ages
- 5 to 50 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Group (I): represents the healthy control individuals Group (II): represents the mild and severe cases of COVID 19 patients.
Key inclusion criteria (1 listed)
- This study will be conducted on a group of patients who are diagnosed as COVID-19 by PCR, a group of them have mild symptoms and another group admitted in ICU (critically ill patients).
Key exclusion criteria (9 listed)
- Any clinical condition cause hypercoagulability state such as:
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 |
|---|---|---|
| laboratory investigations on coagulation profilesCBC ,PT ,aPTT ,Protein C .Protein S ,ATIII and vWF | Diagnostic test | age and sex matched healthy control individuals., mild and severe cases of COVID 19 patients |
Primary outcome
Assess the effect of COVID-19 disease on coagulation cascade in patients of this disease.
Time frame: within the same day of collection of samples
The study will be conducted on a group of patients who are diagnosed as COVID-19 by PCR, All patients and controls were subjected to Full history taking ,clinical examination
Assess the effect of COVID-19 disease on coagulation cascade in patients of this disease.
Time frame: within the same day of collection of samples
The study will be conducted on a group of patients who are diagnosed as COVID-19 by PCR, and All patients and controls were subjected to Laboratory investigations as Complete blood count with platelet indices (MPV measured by fL \& PDW measured by fL) ,
Assess the effect of COVID-19 disease on coagulation cascade in patients of this disease.
Time frame: within the same day of collection of samples
The study will be conducted on a group of patients who are diagnosed as COVID-19 by PCR, and All patients and controls were subjected to Laboratory investigations as Prothrombin time PT measured by seconds and activated partial thromboplastin time aPTT measured by seconds
Assess the effect of COVID-19 disease on coagulation cascade in patients of this disease.
Time frame: within the same day of collection of samples
The study will be conducted on a group of patients who are diagnosed as COVID-19 by PCR, and All patients and controls were subjected to Laboratory investigations as Protein C measured by %, Protein S measured by %, and Antithrombin III measured by %.
Assess the effect of COVID-19 disease on coagulation cascade in patients of this disease.
Time frame: within the same day of collection of samples
The study will be conducted on a group of patients who are diagnosed as COVID-19 by PCR, and All patients and controls were subjected to Laboratory investigations as von Willebrand factor vWF measured by IU per dL.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Patients, run by Sohag University.
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 9 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: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Assess the effect of COVID-19 disease on coagulation cascade in patients of this disease. (time frame: within the same day of collection of samples). The study lists 5 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 19 Oct 2021.