Condition category
Infections and Infestations
Date applied
19/11/2020
Date assigned
20/11/2020
Last edited
23/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of April 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
Indomethacin has shown potent anti-viral properties against SARS-CoV-2 in the lab and against canine coronavirus. It is a well known anti-inflammatory drug. As the body's inflammatory response is responsible for patients progressing to severe disease, this drug may stop the virus from multiplying and calm the immune system. The aim of this study to assess the effectiveness of the drug at preventing mild and moderate patients progressing to severe disease.

Who can participate?
Patients aged 21 to 90 with COVID-19 who are in hospital

What does the study involve?
Participants are treated for 5 days with indomethacin two times a day along with a proton pump inhibitor drug. Standard care is also provided. The following drugs are not to be used: remdesivir, corticosteroids, and paracetamol. Participants are followed up for 14 days and are advised to return to the hospital if they have any problems.

What are the possible benefits and risks of participating?
Benefits may include a quick recovery from COVID-19. The drug has a good safety profile. There have been reports of gastrointestinal (digestive system) bleeding and nephrotoxicity (kidney damage) in higher doses than given in this study. Nevertheless, these will be monitored in the study.

Where is the study run from?
Indian Institute of Technology Madras (India)

When is the study starting and how long is it expected to run for?
July 2020 to January 2021

Who is funding the study?
Mr Kris Gopalakrishnan, Alumnus IIT Madras through the Indian Institute of Technology Madras (India)

Who is the main contact?
1. Dr Rajan Ravichandran
rajanr@iitm.ac.in
2. Prof. R. Krishna Kumar
rkkumar@iitm.ac.in

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ramarathnam Krishna Kumar

ORCID ID

http://orcid.org/0000-0003-4097-6385

Contact details

Department of Engineering Design
Indian Institute of Technology Madras
Chennai
600036
India
+91 (0)9840225856
rkkumar@iitm.ac.in

Type

Scientific

Additional contact

Dr Rajan Ravichandran

ORCID ID

http://orcid.org/0000-0002-3375-2060

Contact details

MIOT Hospitals
4/112 Mount Poonamalle High Road
Sathya Nagar
Mannapakkam
Chennai
600089
India
+91 (0)9840375892
rajanr@iitm.ac.in

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CR/20-21/ED/208/ALUM/002553​

Study information

Scientific title

An academic multicentre open-label single-arm study to record the efficacy of indomethacin among confirmed COVID-19 patients with mild and moderate symptoms

Acronym

Study hypothesis

Indomethacin is effective in the treatment of mild and moderate COVID-19 patients and decreases the hospitalisation of these patients.

Ethics approval

1. Approved 03/08/2020, Institutional Ethics Committee, Narayana Medical College (Nellore 524003, India; +91 (0)8008086119; dean@narayanamedicalcollege.com), ref: NMC/Ethics/Project/006/2020
2. Approved 10/10/2020, Institutional Ethics Committee, Datta Meghe Institute of Medical Sciences (Sawangi (Meghe), Wardha - 442004, Maharashtra, India; +91 (0)7152 287701; icc.dmims@gmail.com), ref: DMIMS(DU)/IEC/2020-21/9034

Study design

Multicenter interventional single-arm open-labelled trial and an academic retrospective study to act as control for comparison

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

1. Indomethacin 25 mg two times a day (or 75 mg SR once a day at the discretion of the treating physician) and a proton pump inhibitor 20 mg (or 40 mg at the discretion of the treating physician) for 5 days
2. Standard care as per the protocol of the hospital
3. The following drugs are not to be administered: remdesivir, corticosteroids, and paracetamol
4. Total duration of treatment: 5 days
5. Follow-up: 14 days
6. The patients are advised to return to the hospital if they have any problems

Intervention type

Drug

Phase

Not Applicable

Drug names

Indomethacin, proton pump inhibitor

Primary outcome measure

Patients deteriorating to severe disease measured using the WHO Ordinal Scale for Clinical Improvement every day during the treatment and after the treatment on the sixth day

Secondary outcome measures

1. Kidney function measured using urea and creatinine before the start of the treatment and after the treatment on the sixth day
2. Liver function measured using SGOT and SGPT before the start of the treatment and after the treatment on the sixth day
3. Inflammation measured using C-reactive protein before the start of the treatment and after the treatment on the sixth day

Overall trial start date

27/07/2020

Overall trial end date

01/01/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 21 to 90 years
2. RT-PCR positive
3. Hospitalised patients
4. The case criteria for the study: LFT and KFT normal

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150 patients in the indomethacin arm and 100 patients for the retrospective study

Participant exclusion criteria

1. Hypersensitivity/allergy to drug
2. Gastritis
3. Recent heart attack
4. Severe asthma
5. Acute kidney Injury
6. Patients on immunosuppressants

Recruitment start date

16/08/2020

Recruitment end date

10/12/2020

Locations

Countries of recruitment

India

Trial participating centre

Narayana Medical College
Nellore
Nellore
524003
India

Trial participating centre

Datta Meghe Institute of Medical Sciences
Sawangi (Meghe)
Wardha
442004
India

Sponsor information

Organisation

Indian Institute of Technology Madras

Sponsor details

Sardar Patel Road
Chennai
600020
India
+91 (0)44 2574600
director@iitm.ac.in

Sponsor type

Government

Website

https://www.iitm.ac.in/

Funders

Funder type

Other

Funder name

Mr Kris Gopalakrishnan, Alumnus IIT Madras through the Indian Institute of Technology Madras

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact journal

IPD sharing statement
The blood tests and CT scans are the data that will be stored and will be available on request from the Principal Investigator of the sites. The request can be sent to the respective centre's ethics committee, who will consider sharing the raw data based on legal and ethical considerations. Consent will be obtained from the participant and data will be anonymised to safeguard the privacy of the participants.

Intention to publish date

01/02/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

RP 23/11/2020: Internal review. 20/11/2020: Uploaded protocol (not peer reviewed) Version number not provided, date not provided. 20/11/2020: Trial's existence confirmed by Institutional Ethics Committees of Narayana Medical College and Datta Meghe Institute of Medical Sciences.