Effect of the drug indomethacin in the treatment of COVID-19 patients
| ISRCTN | ISRCTN11970082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11970082 |
| Secondary identifying numbers | CR/20-21/ED/208/ALUM/002553 |
- Submission date
- 19/11/2020
- Registration date
- 20/11/2020
- Last edited
- 17/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
Contact information
Scientific
Department of Engineering Design
Indian Institute of Technology Madras
Chennai
600036
India
 ORCID ID |
0000-0003-4097-6385 |
|---|---|
| Phone | +91 (0)9840225856 |
| rkkumar@iitm.ac.in |
Scientific
MIOT Hospitals
4/112 Mount Poonamalle High Road
Sathya Nagar
Mannapakkam
Chennai
600089
India
| ORCID ID |
0000-0002-3375-2060 |
|---|---|
| Phone | +91 (0)9840375892 |
| rajanr@iitm.ac.in |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Study hypothesis | Indomethacin is effective in the treatment of mild and moderate COVID-19 patients and decreases the hospitalisation of these patients. |
| Ethics approval(s) | 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 27/07/2020 |
| Overall study end date | 01/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 patients in the indomethacin arm and 100 patients for the retrospective study |
| 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 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
Study participating centres
Nellore
524003
India
Wardha
442004
India
Sponsor information
Government
Sardar Patel Road
Chennai
600020
India
| Phone | +91 (0)44 2574600 |
|---|---|
| director@iitm.ac.in | |
| Website | https://www.iitm.ac.in/ |
"ROR" |
https://ror.org/03v0r5n49 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/02/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact journal |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 20/11/2020 | No | No | ||
| Preprint results | non-peer-reviewed results in preprint | 16/12/2020 | 17/03/2021 | No | No |
Additional files
- ISRCTN11970082_PROTOCOL.pdf
- uploaded 20/11/2020
Editorial Notes
17/03/2021: Preprint reference added.
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.
