| 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
|
|
|
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
|
|
|
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. |