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

Ain Shams University

Status: Completed

Conditions: Corona Virus Infection; Covid19; Hypercoagulability

Treatments: Drug: Rivaroxaban; Drug: Apixaban; Drug: Enoxaparin

Study type: Observational

Funder types: Other

Identifiers

NCT04736901

COVID-Anticoagulants

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 to 65 years..
2. COVID-19 hospitalized patients with pneumonia proved by chest X-ray or CT scan.
3. Confirmed infection with COVID-19 virus using RT-PCR or strongly suspected to be infected with pending confirmation studies.
4. 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

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

Trial design

90 participants in 6 patient groups

Group 1

Description:

Enoxaparin therapeutic dose

Treatment:

Drug: Enoxaparin

Drug: Enoxaparin

Group 2

Description:

Enoxaparin prophylactic dose

Treatment:

Drug: Enoxaparin

Drug: Enoxaparin

Group 3

Description:

Rivaroxaban therapeutic dose

Treatment:

Drug: Rivaroxaban

Drug: Rivaroxaban

Group 4

Description:

Rivaroxaban prophylactic dose

Treatment:

Drug: Rivaroxaban

Drug: Rivaroxaban

Group 5

Description:

Apixaban therapeutic dose

Treatment:

Drug: Apixaban

Drug: Apixaban

Group 6

Description:

Apixaban prophylactic dose

Treatment:

Drug: Apixaban

Drug: Apixaban