Assessment of the Natural Anticoagulant Profile in Patients With COVID-19

NCT05083104 | Unknown

• 1 other identifier: Soh-Med-21-10-09
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 . 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

Conditions

COVID-19 Patients

Outcome Measures

Primary Outcomes (5)

• 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

  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) ,

  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

  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 %.

  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.

  within the same day of collection of samples

Study Arms (2)

age and sex matched healthy control individuals.

controls divided into groups ,each group match in age and sex with cases

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

Diagnostic Test: laboratory investigations on coagulation profiles

Interventions

laboratory investigations on coagulation profiles DIAGNOSTIC_TEST

CBC ,PT ,aPTT ,Protein C .Protein S ,ATIII and vWF

age and sex matched healthy control individuals.; mild and severe cases of COVID 19 patients

Eligibility Criteria

• Age: 5 Years - 50 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Group (I): represents the healthy control individuals Group (II): represents the mild and severe cases of COVID 19 patients.

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of clinical and Chemical pathology

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 19, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 30, 2022
• Last Updated: October 19, 2021

Record last verified: 2021-10