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NCT Number: NCT04736901

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

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.

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Key information

Conditions

Covid19 COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Hematologic Diseases Hemic and Lymphatic Diseases Hypercoagulability Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thrombophilia Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Teachers Hospital

Cairo, Please Select, 11314, Egypt

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enoxaparin

Drug

0.5 mg/kg every 12 hours

Rivaroxaban

Drug

10 mg once daily

Apixaban

Drug

2.5 mg twice daily

Primary outcomes

  1. Change in clotting factors level

    Time frame: Two weeks

    Difference in clotting factors levels between baseline during inclusion in the study and before discharge.

  2. Change in gas exchange over time

    Time frame: Two weeks

    Difference between ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, and before discharge.

  3. Time to increase in oxygenation

    Time frame: Two weeks

    Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2

  4. Duration of hospitalization

    Time frame: Two weeks

    Length of hospital stay

Secondary outcomes

  1. Monitoring of adverse events

    Time frame: Two weeks

    Any signs or symptoms of bleeding will be monitored daily

  2. In hospital mortality rate

    Time frame: Two weeks

    Death occurrence during hospitalization

  3. Monitoring of hemoglobin levels.

    Time frame: Two weeks

    Difference in hemoglobin levels between baseline during inclusion in the study and before discharge.

  4. Monitoring of platelets levels

    Time frame: Two weeks

    Difference in platelets levels between baseline during inclusion in the study and before discharge

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Misr International University

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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