Efficacy and Safety of Apixaban in COVID-19 Coagulopathy Patients With Respiratory Severity Under Critical Care
ECRU
2 other identifiers
interventional
40
1 country
1
Brief Summary
The purpose of the study is to describe the safety and efficacy outcomes of a cohort of ICU patients with severe COVID-19 respiratory disease treated with therapeutic dose Apixaban for COVID-19 at a tertiary public health care setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 covid19
Started Mar 2022
Shorter than P25 for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2021
CompletedFirst Posted
Study publicly available on registry
October 22, 2021
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedMarch 10, 2022
February 1, 2022
3 months
October 21, 2021
February 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bleeding
The participants with bleeding episodes
10 days
Secondary Outcomes (1)
Clotting
10 days
Study Arms (2)
Interventional Arm
EXPERIMENTALEcru (Apixaban )Tablets
Comparator/control
ACTIVE COMPARATORRivascot (Rivaroxaban)
Interventions
Eligibility Criteria
You may qualify if:
- Adult (≥18 years of age)
- All admitted patients with severe or critical COVID-19
- Confirmed diagnosis of COVID-19 through RT-PCR (attach report) and/or HRCT Chest
- Patients at high risk of coagulopathy demonstrating signs of micro-thrombi induced organ dysfunction or strongly suspected macro thromboembolism
You may not qualify if:
- High risk of bleeding as judged by treating physicians
- Contra-indication to therapeutic anti coagulation
- Platelets \< 50,000 (attach report)
- INR \>1.5
- Evidence of current or recent bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scotmann Pharmaceuticalslead
- Rawalpindi Medical Collegecollaborator
Study Sites (1)
Rawalpindi Medical University
Rawalpindi, Punjab Province, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof. Dr. Muhammad Umar, MBBS
Rawalpindi Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Medical Affairs
Study Record Dates
First Submitted
October 21, 2021
First Posted
October 22, 2021
Study Start
March 1, 2022
Primary Completion
May 30, 2022
Study Completion
August 30, 2022
Last Updated
March 10, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share
Proformas