Comparison of efficacy of Indomethacin vs Paracetamol along with standard care of treatment in mild and moderate Covid-19 patients

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2021/05/033544
• Date of registration: 11-05-2021
• Prospective Registration: Yes
• Primary sponsor: IIT Madras
• Public title: Comparison of efficacy of Indomethacin vs Paracetamol along with standard care of treatment in mild and moderate Covid-19 patients
• Scientific title: A Prospective, randomized, open-labelled, active comparator trial of Indomethacin versus Paracetamol among hospitalized patients with confirmed Covid-19.
• Date of first enrolment: 20-05-2021
• Target sample size: 300
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55941
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Ramarathnam Krishna Kumar
• Affiliation: MIOT International

• Name: Dr Rajan Ravichandran
• Affiliation: MIOT International

Key inclusion & exclusion criteria

Inclusion criteria: Age between 20 to 90 years



RT â?? PCR Positive



Hospitalised patients



The case criteria for the study â?? Renal Function Test and Liver Functional Test should be normal at the screening; Oxygen saturation should be 95% or more


Exclusion criteria: Hypersensitivity/Allergy to Drug

Gastritis

Recent Heart attack

Severe Asthma

Acute Kidney Injury.

Patients on immune suppressants

• To Exclude pregnant and lactating mothers

• Specify NSAID/Indomethacin allergy



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J99- Respiratory disorders in diseasesclassified elsewhere

Intervention(s)

Intervention1: Indomethacin: Drug dose - Capsule (C) - 75 mg sustained release formulation once daily for 5 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 that includes the following

C. Doxycycline â?? 100 mg bd; Tablet (T). Ivermectin â?? 12 mg once daily (OD); T. vitamin C 500 mg and D3 60k IU weekly once; T. Zinc 50 mg OD; Cough syrup SOS; T. Cetrizine 10 mg OD /T. Ketotifen 1mg bd SOS; T. Pantoperazole 40 mg bd
Control Intervention1: Paracetamol: Tablet - paracetamol 650 mg 4 times daily for 5 days along with same standard care of treatment mentioned for the intervention drug will be administered orally.

Primary Outcome(s)

Reduction in Covid-19 symptoms and the intervention is expected to be beneficial in reducing the Covid 19 symptoms than the comparatorTimepoint: Day 0 screening

Day 1 to 5 drug administration

Day 7 end of study

Secondary Outcome(s)

Safety both the intervention and comparator are routinely used drugs and are expected to be safe with no adverse effectsTimepoint: Day 0 screening

Day 1 to 5 drug administration

Day 7 end of study

Secondary ID(s)

NIL

Source(s) of Monetary Support

Indian Institute of Madras, Chennai, Tamil Nadu, India

Ethics review

Status: Approved
Approval date: 05/05/2021
Contact:

Panimalar Medical College Hospital and Research Institute â?? Institutional Human Ethics Committee (PMCHRI-IHEC)

Status: Approved
Approval date: 30/05/2021
Contact:

Panimalar Medical College Hospital and Research Institute â?? Institutional Human Ethics Committee (PMCHRI-IHEC)