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

NCT04736901 | Completed DMC FDA Drug

• 1 other identifier: COVID-Anticoagulants
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Corona Virus Infection; Hypercoagulability

Keywords

COVID-19; Hypercoagulability; Anticoagulants

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• Monitoring of adverse events

  Two weeks

• In hospital mortality rate

  Two weeks

• Monitoring of hemoglobin levels.

  Two weeks

• Monitoring of platelets levels

  Two weeks

Study Arms (6)

Group 1

Enoxaparin therapeutic dose

Drug: Enoxaparin

Group 2

Enoxaparin prophylactic dose

Drug: Enoxaparin

Group 3

Rivaroxaban therapeutic dose

Drug: Rivaroxaban

Group 4

Rivaroxaban prophylactic dose

Drug: Rivaroxaban

Group 5

Apixaban therapeutic dose

Drug: Apixaban

Group 6

Apixaban prophylactic dose

Drug: Apixaban

Interventions

Enoxaparin DRUG

0.5 mg/kg every 12 hours

Group 2

Rivaroxaban DRUG

10 mg once daily

Group 4

Apixaban DRUG

2.5 mg twice daily

Group 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead
• Misr International University: collaborator

Study Sites (1)

Teachers Hospital

Cairo, Please Select, 11314, Egypt

Location

Related Publications (1)

• 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. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.

  PMID: 35244208 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Thrombophilia

Interventions

Enoxaparin; Rivaroxaban; apixaban

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Neven Sarhan, PhD

  Misr International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Faculty of Pharmacy

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 3, 2021
• Study Start: December 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)