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 Modification(s)	Statin and Aspirin in SARS-CoV-2 infection
Scientific Title of Study Modification(s)	A Randomised Control Trial of Statin and Aspirin as Adjuvant Therapy in Patients with SARS-CoV-2 Infection (RESIST Trial)
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Deepti Siddharthan  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 Contact Person Scientific Query	Name  Dr Deepti Siddharthan  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 Contact Person Public Query	Name  Dr Deepti Siddharthan  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 Modification(s)	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 Modification(s)	No of Sites = 1   Contact Person  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   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 Modification(s)	Health Type  Condition  Patients  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 Modification(s)	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  ICU admission   10 days or until discharge whichever is longer  In-hospital mortality  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  Progression to ARDS  10 days or until discharge whichever is longer  Progression to shock  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"
Phase of Trial	Phase 2/ Phase 3
Date of First Enrollment (India) Modification(s)	01/08/2020
Date of First Enrollment (Global)	No Date Specified
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 Modification(s)	Nil
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.