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

Completed

• Conditions: Hypercoagulability; Corona Virus Infection; Covid19
• Interventions: Drug: Rivaroxaban; Drug: Apixaban; Drug: Enoxaparin

• Registration Number: NCT04736901
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-03
• Primary Completion: 2021-10-01
• Study Completion: 2021-12-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 4	Rivaroxaban	Rivaroxaban prophylactic dose
Group 5	Apixaban	Apixaban therapeutic dose
Group 1	Enoxaparin	Enoxaparin therapeutic dose
Group 2	Enoxaparin	Enoxaparin prophylactic dose
Group 3	Rivaroxaban	Rivaroxaban therapeutic dose
Group 6	Apixaban	Apixaban prophylactic dose

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Monitoring of hemoglobin levels.	Two weeks	Difference in hemoglobin levels between baseline during inclusion in the study and before discharge.
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 platelets levels	Two weeks	Difference in platelets levels between baseline during inclusion in the study and before discharge

Trial Locations

Locations (1)

Teachers Hospital; 🇪🇬 Cairo, Please Select, Egypt