Effect of Prophylactic and Therapeutic Anticoagulants in Egyptian Patients With COVID-19

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04736901

Collaborator

Misr International University (Other)

Enrollment

Location

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Since the end of 2019, Egypt and the whole world have been suffering from the Coronavirus Disease 2019 (COVID-19) pandemic, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). According to the World Health Organization (WHO), since the emergence of this new pandemic, there have been more than 97 million confirmed cases of COVID-19 patients and two million death globally; around 160 thousand of these cases are in Egypt.

Recent clinical investigations found a high incidence of thrombotic complications in these patients, even with the standard anticoagulant thromboprophylaxis.Coronavirus disease 2019 (COVID-19) causes a hypercoagulable state. Among the pathological sequel of COVID-19 infection, is the presence of a micro-thrombi in the pulmonary circulation which was shown in several autopsy studies. This thrombosis is believed to contribute to gas exchange impairment among patients with COVID-19 infection.

Some observational studies have shown anticoagulation benefits with reduced mortality, mainly in patients requiring mechanical ventilation. However, these findings remain uncertain and need to be validated in further studies.

This study is performed to evaluate whether therapeutic anticoagulation could improve COVID-19 patients' clinical outcomes compared to prophylactic anticoagulation in terms of improving gas exchange, reducing the need to maintain mechanical ventilation, shortening hospital admission period and mortality rate as well as recovering D-dimmer levels to its normal values.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Corona Virus Infection Hypercoagulability	Drug: Enoxaparin Drug: Enoxaparin Drug: Rivaroxaban Drug: Rivaroxaban Drug: Apixaban Drug: Apixaban

Study Design

Study Type:

Observational

Actual Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Effect of Prophylactic and Therapeutic Anticoagulants in Egyptian Patients With COVID-19

Actual Study Start Date :

Dec 1, 2020

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Enoxaparin therapeutic dose	Drug: Enoxaparin 40 mg/day
Group 2 Enoxaparin prophylactic dose	Drug: Enoxaparin 0.5 mg/kg every 12 hours
Group 3 Rivaroxaban therapeutic dose	Drug: Rivaroxaban 20 mg once daily
Group 4 Rivaroxaban prophylactic dose	Drug: Rivaroxaban 10 mg once daily
Group 5 Apixaban therapeutic dose	Drug: Apixaban 5 mg twice daily
Group 6 Apixaban prophylactic dose	Drug: Apixaban 2.5 mg twice daily

Outcome Measures

Primary Outcome Measures

Change in clotting factors level [Two weeks]
Difference in clotting factors levels between baseline during inclusion in the study and before discharge.
Change in gas exchange over time [Two weeks]
Difference between ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, and before discharge.
Time to increase in oxygenation [Two weeks]
Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2
Duration of hospitalization [Two weeks]
Length of hospital stay

Secondary Outcome Measures

Monitoring of adverse events [Two weeks]
Any signs or symptoms of bleeding will be monitored daily
In hospital mortality rate [Two weeks]
Death occurrence during hospitalization
Monitoring of hemoglobin levels. [Two weeks]
Difference in hemoglobin levels between baseline during inclusion in the study and before discharge.
Monitoring of platelets levels [Two weeks]
Difference in platelets levels between baseline during inclusion in the study and before discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Age 18 to 65 years..
COVID-19 hospitalized patients with pneumonia proved by chest X-ray or CT scan.
Confirmed infection with COVID-19 virus using RT-PCR or strongly suspected to be infected with pending confirmation studies.
Prothrombin time/international normalized ratio (INR)<1.5; activated partial thromboplastin time (aPTT)/ratio<1.5, and platelet count greater than 100,000/mm3.

Exclusion Criteria:

Age greater than 85 years-old
Creatinine clearance (CrCl)<10ml/min.
Severe circulatory shock with a dose of norepinephrine higher than 1.0 μg/kg/min.
Pregnant women.
Recent major surgery or severe trauma in the last 3 weeks or recent hemorrhagic stroke in the last 3 months.
Active bleeding, blood dyscrasia such as hemophilia and Von Willebrand factor deficiency.