A study on treatment of COVID-19 patients with study drug along with standard of care

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2020/05/025369
• Date of registration: 27-05-2020
• Prospective Registration: Yes
• Primary sponsor: Medanta Institute of Education and Research MIER
• Public title: A study on treatment of COVID-19 patients with study drug along with standard of care
• Scientific title: A Multi-center, Randomized Controlled, Phase III Study to evaluate the Clinical Outcomes and Safety of Tocilizumab along with Standard of Care in Patients with Cytokine Release Syndrome associated with COVID-19 infection - COVINTOC
• Date of first enrolment: 30-05-2020
• Target sample size: 180
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43485
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Dr Pooja Sharma
• Affiliation: Medanta Institute of Education and Research (MIER)

• Name: Kuldeep K Chauhan
• Affiliation: Medanta Institute of Education and Research (MIER)

Key inclusion & exclusion 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.

XI. Administration of steroids equivalent to methylprednisolone at a dose >1mg/kg/day) at screening/baseline

XII. Absolute Neutrophil count <500, platelet count <50,000 per microliter at screening/baseline

XIII. Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) >10 times upper limit of normal detected with-in 24 hours at screening/baseline



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Intervention1: Tocilizumab and Current Standard of Care: Dose: 6 mg/kg (up to a maximum of 480 mg), Frequency: Once, Route of Administration: Intravenous Infusion, Total duration of administration: 1 Hour and Standard of CARE will be as per individual Hospital (Study Site) Policy
Control Intervention1: Current Standard of Care: Standard of CARE will be as per individual Hospital (Study Site) Policy

Primary Outcome(s)

Proportion of subjects showing progressive COVID 19 disease from moderate to severe, or from severe disease to deathTimepoint: Up to Day 14

Secondary Outcome(s)

1.Time to clinical improvement (TTCI),defined as a National Early Warning SCORE2(NEWS2) of lesser and equal to 2, maintained for 24 hours

2.Proportion of subjects showing Improvement (â?¥1 grade) of CRS

3.Incidence of Mechanical Ventilation

4.Ventilator Free days to day 28

5.Organ Failure-free days to day 28

6.Incidence of Intensive Care (ICU) stay

7.Duration of ICU stay

8.ICU free days

9.Time to Clinical Improvement of COVID-19 grade

10.Mortality rateTimepoint: 1.Upto 28 Days

2.Upto 28 Days

3.Upto 28 Days

4.Upto Day 28

5.Upto Day 28

6.Upto 28 days

7.Upto 28 days

8.Upto 28 days

9.Upto 28 days

10.Days 7, 14, 21 and 28

Secondary ID(s)

TCZ/COVID-19/01/2020 Version 2.0 dated 05 May 2020

Source(s) of Monetary Support

Medanta Institute of Education and Research (MIER) Medanta-The Medicity Sector â?? 38, Gurgaon, Haryana- 122001, India

Ethics review

Status: Approved
Approval date: 08/04/2020
Contact:

Institutional Ethics Committee Fortis Hospitals Limited- Mulund

Status: Approved
Approval date: 25/05/2020
Contact:

Medanta Institutional Ethics Committee

Status: Approved
Approval date: 04/06/2020
Contact:

Institutional Ethics Committee, Pt. B.D. Sharma PGIMS/UHS

Status: Approved
Approval date: 04/06/2020
Contact:

Institutional Ethics Committee-Clinical Studies Apollo Hospitals Enterprises Limited

Status: Approved
Approval date: 04/06/2020
Contact:

Medanta Institutional Ethics Committee

Status: Not Approved
Approval date:
Contact:

Artemis Health Sciences IEC Artemis Hospital

Status: Not Approved
Approval date:
Contact:

IEC of B J G M C and Sassoon General Hospital, B.J G M C and Sassoon General Hospital

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee â?? Clinical Studies Indraprastha Apollo Hospitals

Status: Not Approved
Approval date:
Contact:

Institutional Ethics committee P D Hinduja Hospital & Medical Research Centre

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Fortis Memorial Research Institute

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Sanjay Gandhi Post Graduate Institute of Medical Sciences

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee-Apollo Research and Innovations, Jubilee Hills Apollo Health City

Status: Not Approved
Approval date:
Contact:

Nayati Multi Super Specialty Institutional Ethics Committee

Results

• Date Completed: 12/10/2020