Covid19NCT04736901
Effect of Prophylactic and Therapeutic Anticoagulants in Egyptian Patients With COVID-19
An observational study of Covid19 and Corona Virus Infection, run by Ain Shams University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19, Corona Virus Infection, Hypercoagulability
- What is being tested?
- Enoxaparin, Rivaroxaban and Apixaban
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Enoxaparin, Rivaroxaban, Apixaban
- Keywords
- COVID-19, Hypercoagulability, Anticoagulants
- Medical subject headings
- COVID-19, Coronavirus Infections, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
0.5 mg/kg every 12 hours
EnoxaparinDrug
40 mg/day
RivaroxabanDrug
10 mg once daily
RivaroxabanDrug
20 mg once daily
ApixabanDrug
2.5 mg twice daily
ApixabanDrug
5 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Enoxaparin therapeutic dose Receives: Drug: Enoxaparin | |
| Group 2 | Enoxaparin prophylactic dose Receives: Drug: Enoxaparin | |
| Group 3 | Rivaroxaban therapeutic dose Receives: Drug: Rivaroxaban | |
| Group 4 | Rivaroxaban prophylactic dose Receives: Drug: Rivaroxaban | |
| Group 5 | Apixaban therapeutic dose Receives: Drug: Apixaban | |
| Group 6 | Apixaban prophylactic dose Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clotting factors level
Difference in clotting factors levels between baseline during inclusion in the study and before discharge.
Measured: 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.
Measured: Two weeks
Time to increase in oxygenation
Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2
Measured: Two weeks
Duration of hospitalization
Length of hospital stay
Measured: Two weeks
Secondary outcomes (4)
Monitoring of adverse events
Any signs or symptoms of bleeding will be monitored daily
Measured: Two weeks
In hospital mortality rate
Death occurrence during hospitalization
Measured: Two weeks
Monitoring of hemoglobin levels.
Difference in hemoglobin levels between baseline during inclusion in the study and before discharge.
Measured: Two weeks
Monitoring of platelets levels
Difference in platelets levels between baseline during inclusion in the study and before discharge
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Dec 2020
- Primary completion1 Oct 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr International University
- Responsible party
- Principal investigator, Neven Sarhan, Misr International University
- Investigators
- Neven Sarhan, PhD, Principal investigator, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736901
- Sponsor's protocol ID
- COVID-Anticoagulants
- Status last verified
- Jul 2022
- First submitted
- 1 Feb 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35244208
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylactic and Therapeutic Anticoagulants in Egyptian Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04736901
- Acronym / sponsor ID
- COVID-Anticoagulants
- Conditions
- Covid19, Corona Virus Infection, Hypercoagulability
- Keywords
- COVID-19, Hypercoagulability, Anticoagulants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Misr International University
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: EnoxaparinEnoxaparin therapeutic dose |
| Group 2 | – | Drug: EnoxaparinEnoxaparin prophylactic dose |
| Group 3 | – | Drug: RivaroxabanRivaroxaban therapeutic dose |
| Group 4 | – | Drug: RivaroxabanRivaroxaban prophylactic dose |
| Group 5 | – | Drug: ApixabanApixaban therapeutic dose |
| Group 6 | – | Drug: ApixabanApixaban prophylactic dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin0.5 mg/kg every 12 hours | Drug | Group 2 |
| Enoxaparin40 mg/day | Drug | Group 1 |
| Rivaroxaban10 mg once daily | Drug | Group 4 |
| Rivaroxaban20 mg once daily | Drug | Group 3 |
| Apixaban2.5 mg twice daily | Drug | Group 6 |
| Apixaban5 mg twice daily | Drug | Group 5 |
Primary outcome
Change in clotting factors level
Time frame: Two weeks
Difference in clotting factors levels between baseline during inclusion in the study and before discharge.
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.
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
Duration of hospitalization
Time frame: Two weeks
Length of hospital stay
4 secondary outcomes
Monitoring of adverse events
Time frame: Two weeks
In hospital mortality rate
Time frame: Two weeks
Monitoring of hemoglobin levels.
Time frame: Two weeks
Monitoring of platelets levels
Time frame: Two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 35244208Flumignan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neven Sarhan, PhD principal investigator
Misr International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Corona Virus Infection, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clotting factors level (time frame: Two weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04736901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.