| CTRI Number |
CTRI/2020/07/026791 [Registered on: 25/07/2020] Trial Registered Prospectively |
| Last Modified On: |
24/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Statin and Aspirin in SARS-CoV-2 infection |
|
Scientific Title of Study
|
A Randomised Control Trial of Statin and Aspirin as Adjuvant Therapy in Patients with SARS-CoV-2 Infection (RESIST Trial) |
| Trial Acronym |
RESIST Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepti Siddharthan |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
Department of Cardiology, CNC building (7th floor)
All India Institute of Medical Sciences (AIIMS), New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
deeptikailath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Siddharthan |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
Department of Cardiology, CNC building (7th floor)
All India Institute of Medical Sciences (AIIMS), New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
deeptikailath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Siddharthan |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
Department of Cardiology, CNC building (7th floor)
All India Institute of Medical Sciences (AIIMS), New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
deeptikailath@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi, India |
|
|
Primary Sponsor
|
| Name |
Dr Deepti Siddharthan |
| Address |
Assistant Professor, Department of Cardiology, 7th Floor, CNC building, AIIMS, 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 Deepti Siddharthan |
All India Institute of Medical Sciences, New Delhi |
Department of pulmonary medicine, COVID wards of National cancer institute ,Jhajjar, Haryana-124105, (Covid-19 hospital under AIIMS, New Delhi);
Department of anaesthesia and critical care, COVID wards of JPNA Trauma centre, Ansari Nagar, New Delhi-110029(Covid-19 hospital under AIIMS, New Delhi)
South
DELHI |
9968774019
deeptikailath@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethical Committee |
Approved |
| AIIMS Institute Ethical 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 |
Tablet Aspirin 75mg once daily for ten days or till discharge whichever is later. |
| Intervention |
Atorvastatin (Statin) |
Tablet Atorvastatin 40mg once daily for ten days or till discharge whichever is later |
| Comparator Agent |
Conventional therapy |
Conventional therapy for COVID-19 infected patients |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) RT-PCR positive for SARS-CoV-19 infection,
2)Symptoms (WHO clinical improvement ordinal score 3 to 5) requiring hospital admission,
3)Consenting to participate for the trial.
|
|
| ExclusionCriteria |
| Details |
1) Critical illness with WHO clinical improvement ordinal score >5,
2) Documented significant liver disease / dysfunction (AST/ALT > 240),
3) Myopathy and Rhabdomyolysis (CPK > 5x normal),
4) Allergy or intolerance to statins,
5) Allergy or intolerance to aspirin,
6) Patients taking the following medications: cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor, telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole) clarithromycin and colchicine,
7) Prior statin use (within 30 days),
8) Prior aspirin use (within 30 days),
9) History of active GI bleeding in past three months,
10)Coagulopathy,
11)Thrombocytopenia (Platelet count < 100000/ dl),
12)Pregnancy, active breast-feeding,
13)Patient unable to take oral or nasogastric medications.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical deterioration characterised by progression to WHO clinical improvement ordinal score more than or equal to 6 (i.e., endotracheal intubation, non-invasive mechanical ventilation, pressor agents, RRT, ECMO, and mortality). |
10 days or until discharge whichever is longer |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in serum inflammatory markers (ESR, CRP, and IL-6), Trop I, CPK from time zero to 5th day of study enrollment or 7th day after symptom onset, whichever is later. |
10 days or until discharge whichever is longer |
| Progression to ARDS |
10 days or until discharge whichever is longer |
| Progression to shock |
10 days or until discharge whichever is longer |
| ICU admission |
10 days or until discharge whichever is longer |
| Length of hospital stay |
10 days or until discharge whichever is longer |
| Length of ICU stay |
10 days or until discharge whichever is longer |
| In-hospital mortality |
10 days or until discharge whichever is longer |
Safety concerns - like myalgia, myopathy, rhabdomyolysis, hepatotoxicity, bleedings (minor and major), and others (if any).
|
10 days or until discharge whichever is longer |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
Final Enrollment numbers achieved (Total)= "900"
Final Enrollment numbers achieved (India)="900" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2020 |
| Date of Study Completion (India) |
27/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The clinical manifestations and the severity of illnesses following COVID-19 infections are the result of immune dysregulations. There is an imperative need for the development of antiviral and immunomodulatory drugs that can modify the course of the disease. In this respect, an ideal adjuvant drug should be a low-cost generic medication, easily accessible in pandemics events with an established safety profile. This type of drug should aim at the host’s immune response to alleviate the effects of immune dysregulation. Such anti-inflammatory and immunomodulatory agents may effectively complement the usual care in COVID-19 infection. It is with this premise that we intend to evaluate two commonly used cardioactive drugs with anti-inflammatory properties, statins and aspirin, as adjuvant therapy in COVID-19 infection. It will be a single-centre, prospective, four-arm parallel-group, open-label randomized active-control superiority trial to evaluate the safety and efficacy of atorvastatin and aspirin in reducing clinical deterioration (WHO ordinal scale more than or equal to 6) and serum inflammatory biomarkers in symptomatic (WHO ordinal scale 3-5) COVID-19 infected patients.
|