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CTRI Number  CTRI/2021/08/035567 [Registered on: 10/08/2021] Trial Registered Prospectively
Last Modified On: 10/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Efficacy of Indomethacin along with standard care of treatment versus standard care of treatment in hospitalized Severe Covid -19 patients  
Scientific Title of Study   A Prospective, Randomized, open-labelled, active Comparator trial of Indomethacin and standard care versus Standard care among hospitalized severe Covid-19 patients.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Machandra Reddy Gopate 
Designation  Resident Principal Investigator 
Affiliation  Adichunchanagiri Institute of Medical Sciences 
Address  Department of General Medicine, Ground Floor, Room Number 15, Adichunchanagiri Institute of Medical Sciences, B.G.NAGARA, Mandya.
Mandya.
Mandya
KARNATAKA
571448
India 
Phone  08925744196  
Fax    
Email  drmachandrareddy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajan Ravichandran 
Designation  Director  
Affiliation  MIOT International 
Address  MIOT Institute of Nephrology, MIOT International block, First floor, Room 1, MIOT International, 4/112, Mount Poonamallee Rd, Sathya Nagar, Manapakkam, Chennai, India

Chennai
TAMIL NADU
600089
India 
Phone  9840375892  
Fax    
Email  ravidoc55@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Ramarathnam Krishna Kumar 
Designation  Professor 
Affiliation  IIT Madras 
Address  Department of Engineering Design, Frist floor, 212, Indian Institute of Technology Madras, Chennai, India.

Chennai
TAMIL NADU
600036
India 
Phone  9840225856  
Fax    
Email  rkkumar@iitm.ac.in  
 
Source of Monetary or Material Support  
IIT Madras, Chennai, Tamil Nadu, India  
 
Primary Sponsor  
Name  IIT Madras 
Address  Chennai 600036, Tamil Nadu, India 
Type of Sponsor  Other [Teaching and Research Institute ] 
 
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 Rajesh Venkataraman  Adichunchanagiri Institute of Medical sciences  Department of Pharmacy Practice Room No 35 Ground Floor SAC College of Pharmacy Adichunchanagiri University BG Nagara, Mandya 571448.
Mandya
KARNATAKA 		 9980038331

rajeshvenky_research@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of AH and RC Adichunchanagiri Hospital and Research Center  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  Indomethacin   Drug dose - Capsule (C) - 75 mg sustained release formulation once daily for 7 days for subjects with BMI less than 30; C. 75 mg twice daily for 5 days for subjects with BMI more than 30 will be administered orally, along with standard care of treatment followed in the hospital 
Comparator Agent  Paracetamol  Tablet - paracetamol 650 mg 4 times daily for 5 days along with same standard care of treatment followed in the hospital as advised by regulatory bodies  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age between 20 to 90 years

RT – PCR Positive

Hospitalised patients

dyspnea

A blood oxygen saturation of 93% or less

A ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (Pao2:Fio2) of less than 300 mm Hg, or infiltrates in more than 50% of the lung field
 
 
ExclusionCriteria 
Details  Hypersensitivity/Allergy to Drug

Gastritis

Recent Heart attack

Severe Asthma

Acute Kidney Injury

Patients with known history of Indomethacin allergy will be excluded from the study.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in Covid-19 symptoms and the intervention is expected to be beneficial in reducing the Covid 19 symptoms than the comparator  Day 0 screening
Day 1 to 7 drug
Day 28 end of the study 
 
Secondary Outcome  
Outcome  TimePoints 
Safety both the intervention and comparator are routinely used drugs and are expected to be safe with no adverse effects  Day 0 screening
Day 1 to 7 drug
Day 28 end of the study 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   19/08/2021 
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)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 08-01-2022 and end date provided 08-01-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study is to record the efficacy of Indomethacin compared to paracetamol administered along with the standard care of treatment. This is a prospective, randomized, open – labelled, active Comparator trial of Indomethacin and standard care versus Standard care among hospitalized severe Covid-19 patients.

Study procedure RT – PCR positive severe Covid -19 patients will be randomized to one of the two drug regimens in an open label, randomized, active comparator design post obtaining their consent. 

Study Drug

The usefulness of indomethacin has been established in Covid treatment in an earlier study. Patients will be recruited to the indomethacin- or paracetamol -arm using a randomization algorithm (1:1 ratio). The following drug-dose and –frequency will be administered for the patients in the Indomethacin arm along with the standard care of treatment (without paracetamol) followed in the hospital for severe Covid-19;

Table 1 – Indomethacin dose and frequency

S. No.

Patient BMI

Indomethacin sustained release (SR) formulation –

dose & frequency

1

Less than 30

75 mg once daily for 7 days

2

More than 30

75 mg x 2 for 7 days

Proton Pump Inhibitor (Pantoprazole) 40 mg will be co-administered along with indomethacin

The drug dose is less than or equal to that recommended in the pharmacokinetic study, based on experience and for pragmatic reason. Patients in the standard care will receive paracetamol (Dolo – 650 mg x 4/d or iv) till required.  The dosage can be adjusted as per the decision of the clinician. Both are to be administered along with the hospital’s standard care of treatment for severe Covid-19.  Note: if the treating clinician believes that bacterial pneumonia is likely and requires a second antibacterial agent for “atypical” infection (an uncommon occurrence in COVID-19), patients may receive another agent (e.g., doxycycline or levofloxacin) as appropriate at the clinician’s discretion.

Expected outcome

This trial has been envisaged to bring out a cheap and effective treatment for the COVID – 19 pandemics. Indomethacin seems to satisfy scientifically all the requirements to fight the coronavirus and this trial aims to convert the science into a tangible treatment protocol


 
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