findmyKOL
Clinical trialNCT05706454UnknownPhase 2/PHASE3Interventional

Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For COVID Pneumonia

SponsorKARE BiosciencesEnrollment324COVID-19 PneumoniaCOVID-19 Respiratory Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Phase II/Phase III study to evaluate the safety and efficacy of Ramatroban 75 mg tablet against Placebo in subjects hospitalized for pneumonia due to SARS-CoV-2 infection. Approximately 324 eligible subjects will be randomized in a 1:1 ratio to one of the two treatment groups. Group I: Ramatroban 75 mg tablet + Standard of care; Group II: Placebo + Standard of care. Phase 2 Primary Objective: To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects. Secondary Objective: To assess the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects. Phase 3 Primary Objective: To evaluate the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects. Secondary Objective: To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects. Long COVID \[Follow-up Phase- Objectives- (Phase 2 \& 3)\] 1. To examine lipid mediators, specifically thromboxane A2, prostaglandin D2, F2-isoprostane and/or their metabolites in convalescent subjects after treatment. 2. To assess the efficacy of Ramatroban administered during the acute illness in preventing/mitigating subsequent development of long COVID / PASC

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

India
  • Dec Health Care

    Nellore, Andhra Pradesh, India

    Recruiting
  • Shakti Superspecialty Hospital

    Ahmedabad, Gujarat, India

    Recruiting
  • Lifecare Hospital

    Mumbai, Maharashtra, India

    Recruiting
  • Pdea'S Ayurved Rugnalaya & Sterling Multispeciality Hospital

    Pune, Maharashtra, India

    Recruiting
  • Saikrupa Hospital

    Pune, Maharashtra, India

    Recruiting
  • Sangvi Multispecialty Hospital Pvt Ltd

    Pune, Maharashtra, India

    Recruiting
  • Spandan Hospital

    Pune, Maharashtra, India

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PlaceboRamatroban
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
10 Nov 2022
Primary completion
1 Jul 2024
Completion
31 May 2026
Last update posted
31 Jan 2023
Registered enrollment
324
Registry id
NCT05706454

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.