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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736901
• Other study ID #: COVID-Anticoagulants
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 1, 2021
• Est. primary completion date: October 1, 2021
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Covid19
• Hypercoagulability
• Thrombophilia

Intervention

Drug:
• Enoxaparin
0.5 mg/kg every 12 hours
• Enoxaparin
40 mg/day
• Rivaroxaban
10 mg once daily
• Rivaroxaban
20 mg once daily
• Apixaban
2.5 mg twice daily
• Apixaban
5 mg twice daily

Locations

Country	Name	City	State
Egypt	Teachers Hospital	Cairo	Please Select

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Misr International University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clotting factors level	Difference in clotting factors levels between baseline during inclusion in the study and before discharge.	Two weeks
Primary	Change in gas exchange over time	Difference between ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, and before discharge.	Two weeks
Primary	Time to increase in oxygenation	Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2	Two weeks
Primary	Duration of hospitalization	Length of hospital stay	Two weeks
Secondary	Monitoring of adverse events	Any signs or symptoms of bleeding will be monitored daily	Two weeks
Secondary	In hospital mortality rate	Death occurrence during hospitalization	Two weeks
Secondary	Monitoring of hemoglobin levels.	Difference in hemoglobin levels between baseline during inclusion in the study and before discharge.	Two weeks
Secondary	Monitoring of platelets levels	Difference in platelets levels between baseline during inclusion in the study and before discharge	Two weeks