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CTRI Number  CTRI/2020/06/026118 [Registered on: 24/06/2020] Trial Registered Prospectively
Last Modified On: 24/06/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Antiphospholipid Antibody (APLA) level in COVID-19 Cases.  
Scientific Title of Study   Evaluation of Antiphospholipid Antibody (APA) in COVID-19 Cases.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrRajlaxmi Sarangi 
Designation  Associate Professor 
Affiliation  Kaling Institute of Medical Sciences, BBSR 
Address  Dept. of Biochemistry Kalinga Institute of Medical Sciences(KIMS), KIIT University,Patia, Bhubaneswar
KIMS, KIIT University, Patia, Bhubaneswar, 751024
Khordha
ORISSA
751024
India 
Phone  8940222185  
Fax  0674-2725415  
Email  drrajlaxmisarangi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrRajlaxmi Sarangi 
Designation  Associate Professor 
Affiliation  Kaling Institute of Medical Sciences, BBSR 
Address  Dept. of Biochemistry Kalinga Institute of Medical Sciences(KIMS), KIIT University,Patia, Bhubaneswar
KIMS, KIIT University, Patia, Bhubaneswar, 751024
Khordha
ORISSA
751024
India 
Phone  8940222185  
Fax  0674-2725415  
Email  drrajlaxmisarangi@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrRajlaxmi Sarangi 
Designation  Associate Professor 
Affiliation  Kaling Institute of Medical Sciences, BBSR 
Address  Dept. of Biochemistry Kalinga Institute of Medical Sciences(KIMS), KIIT University,Patia, Bhubaneswar
KIMS, KIIT University, Patia, Bhubaneswar, 751024
Khordha
ORISSA
751024
India 
Phone  8940222185  
Fax  0674-2725415  
Email  drrajlaxmisarangi@gmail.com  
 
Source of Monetary or Material Support  
KIMS( Intramural funding) 
 
Primary Sponsor  
Name  DR Rajlaxmi Sarangi 
Address  Associate Professor, Dept. of Biochemistry,KIMS, Patia, BBSR 
Type of Sponsor  Other [self funding] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajlaxmi Sarangi  KIMS COVID Hospital, BBSR  KIMS, Patia, Bhubaneswar
Khordha
ORISSA 		 8940222185
0674-2725415
drrajlaxmisarangi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Cases: All RT-PCR positive COVID 19 cases admitted to KIMS COVID hospital.
Control: Age and Gender matched apparently healthy Individuals
 
 
ExclusionCriteria 
Details  •RT-PCR positive COVID 19 cases but donot have Recent Surgery
• Pregnancy
• Hypertension, CAD, CKD, CLD, Malignancies
• Obesity, smoking
• Associated systemic autoimmune diseases
• Estrogen intake
• Chronic steroid therapy
• Use of anticoagulant medications , vitamin K antagonists.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
This study will suggest if thrombosis is the major pathology causing seriousness of the disease.   This study will suggest if thrombosis is the major pathology causing seriousness of the disease.  
 
Secondary Outcome  
Outcome  TimePoints 
cured/death  Date of admission to 15 days  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   study not yet started. After doing the study it will be published in Journal having good Impact factor.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Recent works have been described regarding plethora of effects of COVID 19 on coagulation. Studies have even suggested that COVID -19 infection is associated with intra-alveolar fibrin deposition leading to respiratory failure. Hence, anticoagulant and fibrinolytic therapy are recommended to improve clinical outcomes . Few case series have implied that severely affected COVID -19 patients suffer from clinically significant thrombosis.Patients hospitalized for Covid-19 severe infection are more prone to excessive coagulation activation leading to thrombotic events. So, even though COVID 19 is a virus predominantly affecting respiratory system causing pneumonitis researchers have now highlighted thrombosis to be major pathology causing seriousness of patients.current scenario, there are only limited data on APLA in COVID 19 and also it is also not clear if they represent an epiphenomenon or are actually involved in any hemostatic abnormalities seen in COVID 19 disease. Current study will analyse whether antiphospholipid antibodies (IgG / IgM) will throw light on the contribution of thrombosis to seriousness of COVID-19 patients. 
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