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Efficacy of Indomethacin along with standard care of treatment versus standard care of treatment in hospitalized Severe Covid -19 patients

A Prospective, Randomized, open-labelled, active Comparator trial of Indomethacin and standard care versus Standard care among hospitalized severe Covid-19 patients.

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035567
Enrollment
100
Registered
2021-08-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: 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 Control Intervention1: Paracetamol: Table

Sponsors

IIT Madras
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age between 20 to 90 years RT â?? 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 7 drug Day 28 end of the study

Secondary

MeasureTime frame
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 7 drug Day 28 end of the study

Countries

India

Contacts

Public ContactDr Ramarathnam Krishna Kumar

MIOT International

ravidoc55@yahoo.co.in9840375892

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026