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Clinical Trials/CTRI/2020/05/025369
CTRI/2020/05/025369
Completed
Phase 3

A Multi-center, Randomized Controlled, Phase III Study to evaluate the Clinical Outcomes and Safety of Tocilizumab along withStandard of Care in Patients with Cytokine Release Syndrome associated with COVID-19 infection - COVINTOC

Medanta Institute of Education and Research MIER0 sites180 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Medanta Institute of Education and Research MIER
Enrollment
180
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
October 12, 2020
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Medanta Institute of Education and Research MIER

Eligibility Criteria

Inclusion Criteria

  • •I. Male or female subjects who are \>\=18 years of age, on the day of signing informed consent.
  • •II. Patient or Legally Acceptable Representative (LAR) willing to give informed Consent before study procedure.
  • •III. Hospitalized with COVID\-19 infection confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid).
  • •IV. Moderate to severe COVID 19 infection (moderate disease â?? increased respiratory rate 15 to 30/minute and SpO2 90%\-94%; and severe disease \- respiratory rate \>\= 30/minute and/or SpO2 \< 90% on room air, or ARDS or Septic shock

Exclusion Criteria

  • •I. Known severe allergic reactions to TCZ or other monoclonal antibodies
  • •II. Active tuberculosis (TB) infection.
  • •III. Suspected or active bacterial, fungal, viral (except treated HCV or HBV infection), or other infection (besides COVID\-19\).
  • •IV. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
  • •V. Have received oral anti\-rejection or immunomodulatory drugs (including TCZ) with in the past 6 months.
  • •VI. Participating in other drug clinical trials
  • •VII. Pregnant or breastfeeding, or positive pregnancy test in a pre\-dose examination
  • •VIII. Treatment with an investigational drug within 5 half\-lives or 30 days (whichever is longer) of randomization
  • •IX. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the patient safe participation in and completion of the study.
  • •X. Definite diagnosis of rheumatic immune related diseases.

Outcomes

Primary Outcomes

Not specified

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