COVID-19 PneumoniaNCT04998799
Practice Variation on Antithrombotics in COVID-19
An observational study of COVID-19 Pneumonia and Thrombosis, run by NMC Specialty Hospital at 1 site in India.
Trial summary
Evidence suggests coronavirus disease 2019 (COVID-19) is associated with an increased incidence of thromboembolic manifestations. Various guidelines on managing antithrombotics in COVID-19 either provided conflicting guidance or unclear recommendations for post-discharge thromboprophylaxis. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- COVID-19 Pneumonia, Thrombosis, COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Current clinical practices of participating physicians
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 435 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2021to 10 Nov 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 20 to 70 years
- All sexes
- Adult, Older adult
Study population: Physicians from different specialities like Internal Medicine, Pulmonary Medicine, Anesthesiologists, Critical Care Medicine will be recruited through snowballing sampling. A web-based cross-sectional survey will be circulated among the target population by the investigators through e-mail and social media channels.
Who may be able to join
- Physicians involved in the management of adult hospitalised patients with COVID-19 in India
Who cannot join
- Pediatricians
- Physicians involved in the out-patient management of COVID-19
- Refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Current Practices on Antithrombotic Therapy in Hospitalised and Discharged Patients With COVID-19
Evidence suggests coronavirus disease 2019 (COVID-19) is associated with an increased incidence of thromboembolic manifestations. Various guidelines on managing antithrombotics in COVID-19 either provided conflicting guidance or unclear recommendations for post-discharge thromboprophylaxis.
The investigators aim to collect the current practices in India among physicians on antithrombotic therapy for hospitalised patients with COVID-19 and after discharge from the hospital.
Read the detailed description
Immune dysregulation plays a crucial role in the development of severe coronavirus disease 2019 (COVID-19). The autopsy of lungs in deceased COVID-19 patients showed micro thrombosis and inflammatory infiltrates similar to acute respiratory distress syndrome (ARDS). Reports of increased incidence of arterial or venous thrombosis with COVID-19 made initial recommendations regarding using higher doses of anticoagulation. The markers of thrombosis like D-dimer, platelet count, fibrinogen are also increased in patients with COVID-19 along with other inflammatory markers. The pathophysiology of coagulopathy of COVID-19 is still under research. It is likely multi-factorial involving Inflammation, hypoxia, endothelial dysfunction, direct viral cytopathic effect, platelets and complement activation, derangement of the renin-angiotensin-aldosterone pathway.
From the inception of the pandemic, the physicians started using various antithrombotic with higher than prophylactic doses to treat the prothrombotic state. In the absence of clear guidance with conflicting evidence, there is considerable variation in the practices of physicians managing COVID-19.
The investigators are planning for a nationwide multicentre cross-sectional survey on understanding participating physicians practices on the choice of different antithrombotics available in India as of August 2021.
The survey will have three sections: 1. Demographics 2. Antithrombotics in hospitalised patients 3. Antithrombotics after discharge from the hospital
The investigators intend to involve 1000 physicians from different specialities with the help of the steering committee.
- Conditions
- COVID-19 Pneumonia, Thrombosis, COVID-19 Acute Respiratory Distress Syndrome, Severe Acute Respiratory Syndrome (SARS) Pneumonia
- Being tested
- Current clinical practices of participating physicians
- Keywords
- Anticoagulation in COVID-19, Anticoagulants, SARS-CoV-2, Coronavirus Disease 2019, Management of COVID-19
- Medical subject headings
- Thrombosis, Severe Acute Respiratory Syndrome, Pneumonia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current clinical practices of participating physiciansBehavioural
Current clinical practice of participating physicians on management of antithrombotics for COVID-19 during hospitalisation and post-discharge
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice, dose, and indication of antithrombotics for management of COVID-19.
Through web-based cross-sectional survey will capture the practices of physicians on choice, dose, and indication of antithrombotics for management of COVID-19 during hospitalisation and post-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 posted10 Aug 2021
- Study start1 Oct 2021
- Primary completion30 Oct 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMC Specialty Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prashant Nasa, NMC Specialty Hospital
- Investigators
- Prashant Nasa, MD EDICM, Principal investigator, NMC Specialty Hospital, Dubai, UAE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998799
- Sponsor's protocol ID
- ATCOVIDIndia
- Status last verified
- Nov 2021
- First submitted
- 8 Aug 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chandra A, Chakraborty U, Ghosh S, Dasgupta S. Anticoagulation in COVID-19: current concepts and controversies. Postgrad Med J. 2022 May;98(1159):395-402. doi: 10.1136/postgradmedj-2021-139923. Epub 2021 Apr 13.
PubMed 33850011Fontelo P, Bastola MM, Zheng Z, Baik SH. A review of thromboembolic events in hospitalized COVID-19 patients. Thromb J. 2021 Jun 29;19(1):47. doi: 10.1186/s12959-021-00298-3.
PubMed 34187490Jagiasi B, Nasa P, Chanchalani G, Ahmed A, Ak AK, Sodhi K, Mangal K, Singh MK, Gupta N, Bidkar PU, Tyagi RS, Khanikar RG, Tripathy S, Khanzode S, Subba Reddy K, Saigal S, Sivakumar VA, Javeri Y, Tekwani SS. Variation in therapeutic strategies for the management of severe COVID-19 in India: A nationwide cross-sectional survey. Int J Clin Pract. 2021 Oct;75(10):e14574. doi: 10.1111/ijcp.14574. Epub 2021 Jul 18.
PubMed 34171154Liu Y, Cai J, Wang C, Jin J, Qu L. A systematic review and meta-analysis of incidence, prognosis, and laboratory indicators of venous thromboembolism in hospitalized patients with coronavirus disease 2019. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1099-1111.e6. doi: 10.1016/j.jvsv.2021.01.012. Epub 2021 Jan 30.
PubMed 33529719
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Practices on Antithrombotic Therapy in Hospitalised and Discharged Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04998799
- Acronym / sponsor ID
- ATCOVIDIndia
- Conditions
- COVID-19 Pneumonia, Thrombosis, COVID-19 Acute Respiratory Distress Syndrome, Severe Acute Respiratory Syndrome (SARS) Pneumonia
- Keywords
- Anticoagulation in COVID-19, Anticoagulants, SARS-CoV-2, Coronavirus Disease 2019, Management of COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- NMC Specialty HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 10 Aug 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.
Evidence suggests coronavirus disease 2019 (COVID-19) is associated with an increased incidence of thromboembolic manifestations. Various guidelines on managing antithrombotics in COVID-19 either provided conflicting guidance or unclear recommendations for post-discharge thromboprophylaxis.
The investigators aim to collect the current practices in India among physicians on antithrombotic therapy for hospitalised patients with COVID-19 and after discharge from the hospital.
Detailed description
Immune dysregulation plays a crucial role in the development of severe coronavirus disease 2019 (COVID-19). The autopsy of lungs in deceased COVID-19 patients showed micro thrombosis and inflammatory infiltrates similar to acute respiratory distress syndrome (ARDS). Reports of increased incidence of arterial or venous thrombosis with COVID-19 made initial recommendations regarding using higher doses of anticoagulation. The markers of thrombosis like D-dimer, platelet count, fibrinogen are also increased in patients with COVID-19 along with other inflammatory markers. The pathophysiology of coagulopathy of COVID-19 is still under research. It is likely multi-factorial involving Inflammation, hypoxia, endothelial dysfunction, direct viral cytopathic effect, platelets and complement activation, derangement of the renin-angiotensin-aldosterone pathway.
From the inception of the pandemic, the physicians started using various antithrombotic with higher than prophylactic doses to treat the prothrombotic state. In the absence of clear guidance with conflicting evidence, there is considerable variation in the practices of physicians managing COVID-19.
The investigators are planning for a nationwide multicentre cross-sectional survey on understanding participating physicians practices on the choice of different antithrombotics available in India as of August 2021.
The survey will have three sections: 1. Demographics 2. Antithrombotics in hospitalised patients 3. Antithrombotics after discharge from the hospital
The investigators intend to involve 1000 physicians from different specialities with the help of the steering committee.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Physicians from different specialities like Internal Medicine, Pulmonary Medicine, Anesthesiologists, Critical Care Medicine will be recruited through snowballing sampling. A web-based cross-sectional survey will be circulated among the target population by the investigators through e-mail and social media channels.
Key inclusion criteria (1 listed)
- Physicians involved in the management of adult hospitalised patients with COVID-19 in India
Key exclusion criteria (3 listed)
- Pediatricians
- Physicians involved in the out-patient management of COVID-19
- Refused to participate
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 |
|---|---|---|
| Current clinical practices of participating physiciansCurrent clinical practice of participating physicians on management of antithrombotics for COVID-19 during hospitalisation and post-discharge | Behavioural | – |
Primary outcome
Choice, dose, and indication of antithrombotics for management of COVID-19.
Time frame: two weeks
Through web-based cross-sectional survey will capture the practices of physicians on choice, dose, and indication of antithrombotics for management of COVID-19 during hospitalisation and post-discharge
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 24 Nov 2021.
- Background: PubMed 33850011Chandra A, Chakraborty U, Ghosh S, Dasgupta S. Anticoagulation in COVID-19: current concepts and controversies. Postgrad Med J. 2022 May;98(1159):395-402. doi: 10.1136/postgradmedj-2021-139923. Epub 2021 Apr 13.
- Background: PubMed 34187490Fontelo P, Bastola MM, Zheng Z, Baik SH. A review of thromboembolic events in hospitalized COVID-19 patients. Thromb J. 2021 Jun 29;19(1):47. doi: 10.1186/s12959-021-00298-3.
- Background: PubMed 34171154Jagiasi B, Nasa P, Chanchalani G, Ahmed A, Ak AK, Sodhi K, Mangal K, Singh MK, Gupta N, Bidkar PU, Tyagi RS, Khanikar RG, Tripathy S, Khanzode S, Subba Reddy K, Saigal S, Sivakumar VA, Javeri Y, Tekwani SS. Variation in therapeutic strategies for the management of severe COVID-19 in India: A nationwide cross-sectional survey. Int J Clin Pract. 2021 Oct;75(10):e14574. doi: 10.1111/ijcp.14574. Epub 2021 Jul 18.
- Background: PubMed 33529719Liu Y, Cai J, Wang C, Jin J, Qu L. A systematic review and meta-analysis of incidence, prognosis, and laboratory indicators of venous thromboembolism in hospitalized patients with coronavirus disease 2019. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1099-1111.e6. doi: 10.1016/j.jvsv.2021.01.012. Epub 2021 Jan 30.
- Individual participant dataSharing planned: No
Related trials for COVID-19 Pneumonia
RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Lupus Education Alliance Program
Systemic Lupus Erythematosus, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
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.
Prashant Nasa, MD EDICM principal investigator
NMC Specialty Hospital, Dubai, UAE
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 COVID-19 Pneumonia and Thrombosis, run by NMC Specialty Hospital at 1 site in India.
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 1 inclusion and 3 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 24 Nov 2021. 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 India. 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?
Choice, dose, and indication of antithrombotics for management of COVID-19. (time frame: two weeks). 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 NCT04998799, which also lists 4 linked publications.
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 24 Nov 2021.