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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-12-01

Brief Summary

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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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Detailed Description

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Conditions

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Covid19 Corona Virus Infection Hypercoagulability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Group 1

Enoxaparin therapeutic dose

Enoxaparin

Intervention Type DRUG

40 mg/day

Group 2

Enoxaparin prophylactic dose

Enoxaparin

Intervention Type DRUG

0.5 mg/kg every 12 hours

Group 3

Rivaroxaban therapeutic dose

Rivaroxaban

Intervention Type DRUG

20 mg once daily

Group 4

Rivaroxaban prophylactic dose

Rivaroxaban

Intervention Type DRUG

10 mg once daily

Group 5

Apixaban therapeutic dose

Apixaban

Intervention Type DRUG

5 mg twice daily

Group 6

Apixaban prophylactic dose

Apixaban

Intervention Type DRUG

2.5 mg twice daily

Interventions

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Enoxaparin

0.5 mg/kg every 12 hours

Intervention Type DRUG

Enoxaparin

40 mg/day

Intervention Type DRUG

Rivaroxaban

10 mg once daily

Intervention Type DRUG

Rivaroxaban

20 mg once daily

Intervention Type DRUG

Apixaban

2.5 mg twice daily

Intervention Type DRUG

Apixaban

5 mg twice daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No