A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia

Purpose

This study will assess the pharmacodynamics, pharmacokinetics, safety and efficacy of two different doses of tocilizumab (TCZ) in combination with standard-of-care (SOC) in hospitalized adult participants with moderate to severe COVID-19 pneumonia.

Condition

  • COVID-19 Pneumonia

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Hospitalization with COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen [e.g., respiratory, blood, urine, stool, and other bodily fluids]) and evidence of pneumonia on chest X-ray or computed tomography scan - For severe patients, SpO2 </= 93% or PaO2/FiO2 < 300 mmHg. If a participant is on supplemental oxygen with SpO2 > 93%, but desaturation </= to 93% on lower supplemental oxygen or ambient air is documented during screening, the inclusion criterion is met - For moderate patients (those who do not qualify as severe based oxygen requirements), CRP > 2 x upper limit of normal (ULN) is required - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined by the protocol - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined by the protocol

Exclusion Criteria

  • Known severe allergic reactions to TCZ or other monoclonal antibodies - Active tuberculosis (TB) infection - Suspected active bacterial, fungal, viral, or other infection (besides SARS-CoV-2) - Participants who are on a mechanical ventilator > 24 hours or extracorporeal membrane oxygenation (ECMO), in shock, or combination thereof with other organ failure requiring treatment in an ICU - In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments - Receipt of oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x ULN detected within 24 hours at screening or at baseline (according to local laboratory reference ranges) - Absolute neutrophil count (ANC) < 1000/uL at screening and baseline (according to local laboratory reference ranges) - Platelet count < 50,000/uL at screening and baseline (according to local laboratory reference ranges) - Pregnancy or breastfeeding, or positive pregnancy test at a predose examination - Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days (whichever is longer) of randomization

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
TCZ 8 mg/kg 		Participants will receive intravenous (IV) tocilizumab (TCZ) at a dose of 8 mg/kg in addition to standard-of-care treatment.
  • Drug: Tociliuzumab
    Participants will receive IV TCZ.
Experimental
TCZ 4 mg/kg 		Participants will receive IV tocilizumab (TCZ) at a dose of 4 mg/kg in addition to standard-of-care treatment.
  • Drug: Tociliuzumab
    Participants will receive IV TCZ.

Recruiting Locations

More Details

NCT ID
NCT04363736
Status
Completed
Sponsor
Hoffmann-La Roche