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| Name | Class |
|---|---|
| Misr International University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Enoxaparin therapeutic dose |
| |
| Group 2 | Enoxaparin prophylactic dose |
| |
| Group 3 | Rivaroxaban therapeutic dose |
| |
| Group 4 | Rivaroxaban prophylactic dose |
| |
| Group 5 | Apixaban therapeutic dose |
| |
| Group 6 | Apixaban prophylactic dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | 0.5 mg/kg every 12 hours |
| |
| Enoxaparin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in clotting factors level | Difference in clotting factors levels between baseline during inclusion in the study and before discharge. | Two weeks |
| 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 |
| Time to increase in oxygenation | Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2 | Two weeks |
| Duration of hospitalization | Length of hospital stay | Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Monitoring of adverse events | Any signs or symptoms of bleeding will be monitored daily | Two weeks |
| In hospital mortality rate | Death occurrence during hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Neven Sarhan, PhD | Misr International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teachers Hospital | Cairo | Please Select | 11314 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35244208 | Derived | Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D019851 | Thrombophilia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| Drug |
40 mg/day |
|
| Rivaroxaban | Drug | 10 mg once daily |
|
| Rivaroxaban | Drug | 20 mg once daily |
|
| Apixaban | Drug | 2.5 mg twice daily |
|
| Apixaban | Drug | 5 mg twice daily |
|
| Two weeks |
| Monitoring of hemoglobin levels. | Difference in hemoglobin levels between baseline during inclusion in the study and before discharge. | Two weeks |
| Monitoring of platelets levels | Difference in platelets levels between baseline during inclusion in the study and before discharge | Two weeks |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002241 |
| Carbohydrates |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |