A RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN HOSPITALIZED PATIENTS WITH COVID-19 PNEUMONIA

Not Applicable

Recruiting

• Conditions: -J128 Other viral pneumonia; Other viral pneumonia; J128

• Registration Number: PER-027-20
• Lead Sponsor: GENETECH, INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Study Completion: 2022-01-05
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1) Documented informed consent by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative
2) Age 18 years
3) Ability to comply with the study protocol
4) Hospitalized
5) COVID-19 pneumonia confirmed per a positive PCR of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and radiographic imaging (CT scan or chest X-ray)
6) Able to complete screening within 96 hours of hospital admission.
7) Blood oxygen saturation (SpO2) 94% while on ambient air
8) For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
9) For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.

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 anti-viral 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