A Clinical Study to Test the Effectiveness and Side Effects of Hetero-Tocilizumab in Severe COVID-19 Patients
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2021/05/033703
- Lead Sponsor
- Hetero Biopharma Limited
- Brief Summary
This is a multicentric, prospective, double blind, randomized, parallel, clinical study to evaluate the efficacy, safety and tolerability of Hetero-Tocilizumab therapy in patients with cytokine storm of severe corona virus disease (COVID-19) pneumonia. This is a parallel study with enrolment in 3:1 ratio. Standard of care will be given in both arms as per the Clinical Management Protocol of ICMR, Ministry of Health and Family Welfare, Government of India.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 188
- Adult male and female (18-65 years age both inclusive) patients and willing to provide written informed consent.
- Hospitalized with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen 3.
- Patients with the severe COVID-19 defined as patients with clinical signs of pneumonia plus one of the following: respiratory rate >30 breaths/min and severe respiratory distress or SpO2 <90% on room air.
- Patients with elevated IL-6 (>40 pg/ml), D-dimer >1.5 μgFEU /ml, Elevated CRP (>75mg/L) and ferritin 5X ULN.
- Patients contraindicated or with history/ evidence of hypersensitivity to Tocilizumab or any of the components of formulation.
- Patients requiring intubation and mechanical ventilation 3.
- Patients with ALT/AST ≥ 5 x upper limit of normal (ULN) 4.
- Patients with platelet counts <1,00,000/cmm or absolute neutrophil counts <2000/cmm 5.
- Patients received oral anti-rejection or immunomodulatory drugs (including tocilizumab) within the past 3 months 6.
- Patients of immunocompromised status or on immunosuppressive therapy (except for steroids for COVID only), advanced cancer 7.
- Evidence of multiorgan failure 8.
- Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization 9.
- Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative proportion of patients requiring mechanical ventilation Day 14
- Secondary Outcome Measures
Name Time Method Proportion of patients with 2-point decrease in ordinal scale (as recommended by WHO) Day 14 and 28 Time to 2-point decrease in ordinal scale (as recommended by WHO) from randomization. Up to Day 28 Incidence and severity of TEAEs (clinical and laboratory) during the study All Visits Proportion of patients discontinued the study due to adverse events All Visits Mortality Rate during the study Day 14 and 28
Trial Locations
- Locations (10)
Down Town Hospital
🇮🇳Dhubri, ASSAM, India
Gandhi Hospital and Medical College
🇮🇳Hyderabad, TELANGANA, India
GMERS Medical College & Hospital
🇮🇳Vadodara, GUJARAT, India
Govt. Medical college & Govt. General Hospital (Old RIMSGGH)
🇮🇳Srikakulam, ANDHRA PRADESH, India
Jawahar Lal Nehru Medical College
🇮🇳Ajmer, RAJASTHAN, India
Lokmanya Tilak Municipal Medical College & General Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Maharaja Agrasen Superspeciality Hospital
🇮🇳Jaipur, RAJASTHAN, India
Sir Sayaji Rao General Hospital
🇮🇳Vadodara, GUJARAT, India
St,Theresa’s Hospital
🇮🇳Hyderabad, TELANGANA, India
VHS Infectious Diseases Medical Centre
🇮🇳Chennai, TAMIL NADU, India
Down Town Hospital🇮🇳Dhubri, ASSAM, IndiaDr Swapnav BorthakurPrincipal investigator9864038704swapnav.borthakur@gmail.com