A study to evaluate the safety and efficacy of tocilizumab in patients with severe COVID-19 pneumonia

Not Applicable

Completed

• Conditions: COVID-19 (SARS-CoV-2 infection) pneumonia; Infections and Infestations

• Registration Number: ISRCTN13593711
• Lead Sponsor: Genentech

Brief Summary

2020 non-peer-reviewed results in preprint https://doi.org/10.1101/2020.08.27.20183442 (added 21/01/2021) 2021 results in https://doi.org/10.1056/NEJMoa2028700 (added 17/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-07-28
• Study Start: 2021-01-21
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 452

Inclusion Criteria

1. Hospitalized with COVID-19 pneumonia confirmed per a positive PCR of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
2. SPO2

Exclusion Criteria

1. Known severe allergic reactions to TCZ or other monoclonal antibodies
2. Active tuberculosis (TB) infection
3. Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
4. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
5. Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past 3 months
6. Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by Medical Monitor)
7. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
8. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medial Monitor)
9. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
10. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >10 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
11. Absolute neutrophil count (ANC) < 1000/ml at screening (per local lab)
12. Platelet count < 50,000/mL at screening (per local lab)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical status assessed using a 7-category ordinal scale on day 28