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CTRI Number  CTRI/2020/07/026791 [Registered on: 25/07/2020] Trial Registered Prospectively
Last Modified On: 11/10/2020
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  
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 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  
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  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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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. 

 

 

 
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