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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04736901
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : February 4, 2021
Sponsor:
Collaborator:
Misr International University
Information provided by (Responsible Party):
Neven Sarhan, Misr International 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.


Condition or disease Intervention/treatment
Covid19 Corona Virus Infection Hypercoagulability Drug: Enoxaparin Drug: Rivaroxaban Drug: Apixaban

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Effect of Prophylactic and Therapeutic Anticoagulants in Egyptian Patients With COVID-19
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : June 1, 2021


Group/Cohort Intervention/treatment
Group 1
Enoxaparin therapeutic dose
Drug: Enoxaparin
40 mg/day

Group 2
Enoxaparin prophylactic dose
Drug: Enoxaparin
0.5 mg/kg every 12 hours

Group 3
Rivaroxaban therapeutic dose
Drug: Rivaroxaban
20 mg once daily

Group 4
Rivaroxaban prophylactic dose
Drug: Rivaroxaban
10 mg once daily

Group 5
Apixaban therapeutic dose
Drug: Apixaban
5 mg twice daily

Group 6
Apixaban prophylactic dose
Drug: Apixaban
2.5 mg twice daily




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The current research is including moderate and severe SARS-COV-2 patients receiving the same background treatment for 5 days, following an Institutional protocol for standard of care: hydroxychloroquine 400 mg daily, lopinavir/ritonavir 400/100 mg twice daily or/and remdisivir 200 mg LD then 100 once daily as a maintenance dose and anti-coagulation prophylaxis with enoxaparin subcutaneously once a day if D-dimmer between 500-1000 or enoxaparin therapeutic subcutaneously twice daily if D-dimmer >1000.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04736901


Contacts
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Contact: Neven Sarhan, PhD 01021944422 sarhanneven@gmail.com
Contact: mona farag schaalan, PhD mona.schaalan@miuegypt.edu.eg

Locations
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Egypt
Teachers Hospital Recruiting
Cairo, Please Select, Egypt, 11314
Contact: Neven Sarhan, PhD    01021944422    sarhanneven@gmail.com   
Contact       mona.schaalan@miuegypt.edu.eg   
Sub-Investigator: Neven M. Sarhan, PhD         
Sub-Investigator: Mona F schaalan, PhD         
Principal Investigator: Shaimaa Fathy, PhD         
Sub-Investigator: Ahmed Essam, MS         
Sponsors and Collaborators
Ain Shams University
Misr International University
Investigators
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Principal Investigator: Neven Sarhan, PhD Misr International University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Neven Sarhan, Lecturer at Faculty of Pharmacy, Misr International University
ClinicalTrials.gov Identifier: NCT04736901    
Other Study ID Numbers: COVID-Anticoagulants
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Neven Sarhan, Misr International University:
COVID-19
Hypercoagulability
Anticoagulants
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Thrombophilia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Hematologic Diseases
Enoxaparin
Rivaroxaban
Apixaban
Enoxaparin sodium
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents