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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04736901
Other study ID # COVID-Anticoagulants
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
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