Completed
COVACTAA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
What is being tested
Tocilizumab (TCZ)
+ Placebo
Drug
Who is being recruted
Over 18 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 3
Interventional
Study Start: April 2020
Summary
Principal SponsorHoffmann-La Roche
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 3, 2020
Actual date on which the first participant was enrolled.This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.
Official TitleA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Principal SponsorHoffmann-La Roche
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
452 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
2 inclusion criteria required to participate
Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
SPO2 </=93% or PaO2/FiO2 <300 mmHg
12 exclusion criteria prevent from participating
Known severe allergic reactions to TCZ or other monoclonal antibodies
Active tuberculosis (TB) infection
Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalParticipants will receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.
Group II
PlaceboParticipants will receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.
Study Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 62 locations
Suspended
University of California San Diego
La Jolla, United StatesOpen University of California San Diego in Google MapsSuspended
eStudySite
La Mesa, United StatesSuspended
David Geffen School of Medicine UCLA
Los Angeles, United StatesSuspended
Stanford University
Stanford, United StatesCompleted62 Study Centers