Overview
A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia
Status:
Completed
Completed
Trial end date:
2020-08-12
2020-08-12
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hoffmann-La Roche
Criteria
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