FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/08/027503 [Registered on: 31/08/2020] Trial Registered Prospectively
Last Modified On: 31/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of blood thinning medicine in COVID-19 infection 
Scientific Title of Study   Low Dose Aspirin in Moderate to Severe SARS- CoV-2 Infected Patients: A Pilot Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Souvik Maitra 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No: 5011, 5th Floor Teaching Block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  08146727891  
Fax    
Email  souvikmaitra@live.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Souvik Maitra 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No: 5011, 5th Floor Teaching Block, All India Institute of Medical Sciences, New Delhi


DELHI
110029
India 
Phone  08146727891  
Fax    
Email  souvikmaitra@live.com  
 
Details of Contact Person
Public Query
 
Name  Dr Souvik Maitra 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No: 5011, 5th Floor Teaching Block, All India Institute of Medical Sciences, New Delhi


DELHI
110029
India 
Phone  08146727891  
Fax    
Email  souvikmaitra@live.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  Dr Souvik Maitra 
Address  Room No: 5011, Teaching Block, All India Institute of Medical Sciences, New Delhi- 110029 
Type of Sponsor  Other [Self] 
 
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 Souvik Maitra  All India Institute of Medical Sciences, New Delhi  DEPARTMENT OF ANAESTHESIOLOGY, ROOM NO: 5011, 5TH FLOOR TEACHING BLOCK, All India Institute of Medical Sciences, New Delhi- 110029
South
DELHI 
08146727891

souvikmaitra@live.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute 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 
Intervention  Aspirin  Low dose aspirin (75 mg OD) for 10 days along with standard of care 
Comparator Agent  Standard of Care  Standard of care will included standard practice of the institute at that time 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult (aged between 18 and 65y) patients with laboratory confirmed SARS- CoV-2 infection with hypoxemia (defined by room air SpO2 ≤ 94%) at the time of randomization will be included. 
 
ExclusionCriteria 
Details  1. Refusal to participate
2. Mechanically ventilated patients
3. Patients with P/F ratio < 150 mm Hg
4. Patients with any known coagulation disorder
5. Patients with known platelet function disorder
6. Patients who are already on antiplatelet therapy
7. Patients with thrombocytopenia (platelet count < 100,000/ cmm)
8. Patients with any previous intracranial pathology
9. Patients with known gastric/ duodenal ulcer
10. Patients with history of gastro-intestinal bleeding within 3 months
11. Pregnancy women or women who are breastfeeding their children
12. Known allergy to aspirin
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare SpO2/ FiO2 ratio in day 1- 7 post randomization in both the groups  day 1- 7 post randomization  
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the ventilation free days (VFD.
2. To compare the high flow nasal oxygen and/ or NIV free days (NVFD) in both the groups.
3. To compare supplemental oxygen free days (OFD).
4. To compare mortality in both the groups.
 
28 day post randomization 
5. To compare duration of hospital stay in both the groups.
6. To compare incidence of new onset non- respiratory organ dysfunction (AKI) in both the groups.
7. To compare any adverse effects (major bleeding requiring transfusion, minor bleeding).
8. To compare the incidence of lower limb deep vein thrombosis in both the groups
 
Till hospital discharge/ 28 day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/06/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Study Protocol

Clinical management of all patients including fluid therapy, oxygen therapy, drug therapy, monitoring of vitals, baseline blood investigations, chest X ray and point of care ultrasound will be as per standard Institute protocol.  Oxygen by facemask will be provided when room air oxyhemoglobin saturation< 94%) and high flow nasal oxygen (HFNO) therapy will be used when oxyhemoglobin saturation < 92% despite of 10L/min of oxygen by normal facemask. Non-invasive / invasive mechanical ventilation will be initiated if a patient develops increasing respiratory distress and hypoxia even with HFNO.

 
Close