Trial of Tocilizumab for Treatment of Severe COVID-19: ARCHITECTS

NCT04412772 | Terminated Phase 3 FDA Drug

• 1 other identifier: RA-2020-019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective is to evaluate the clinical efficacy and safety of tocilizumab relative to placebo among approximately 300 hospitalized adult patients who have severe COVID-19. The study will be a 2 arm double blinded comparison between tocilizumab 8 mg/kg and matching placebo IV. The dose may be repeated in 8-12 hours if clinical symptoms worsens, (e.g. increase in oxygen requirements). Participants will be followed for 28 days.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Clinical status (on a 7-point ordinal scale) at day 28

  Clinical Status 7-point ordinal scale: 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death

  up to day 28

Secondary Outcomes (3)

• Clinical improvement

  up to day 28

• Mechanical Ventilation

  up to day 28

• Oxygenation

  up to day 28

Study Arms (2)

Tocilizumab (TCZ) Arm

EXPERIMENTAL

Participants 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.

Drug: Tocilizumab

Placebo Arm

PLACEBO COMPARATOR

Participants will receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen.

Drug: Placebo

Interventions

Tocilizumab DRUG

Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen.

Also known as: Actemra

Tocilizumab (TCZ) Arm

Placebo DRUG

Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen.

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ii. Hospitalized with COVID-19 pneumonia, based on chest X-ray or CT scan AND iii. Evidence of hyperinflammation: IL-6\>40pg/mL (if available) OR CRP \>2 mg/dL OR ferritin \>2000 ng/mL AND iv. One or more of the following: impending need for requiring invasive or non-invasive mechanical ventilation OR shock requiring vasopressor (without evidence of bacterial / fungal infection) OR need for extracorporeal membrane oxygenation (ECMO) OR severe, refractor ARDS (PaO2/FiO2\<200 mmHg)

You may not qualify if:

• Known severe allergic reactions to tocilizumab or other monoclonal antibodies
• Active tuberculosis infection based on history
• 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
• Have received oral anti-rejection or immunomodulatory drugs (including tocilizumab) with the past 6 months
• Participating in other drug clinical trials (participation in COVID-19 trials allowed)
• Self-reported pregnant or breastfeeding
• 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
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 10 x upper limit of normal (ULN) detected within 24 hours at baseline
• Absolute neutrophil count (ANC) \< 1000/mL at baseline
• Platelet count \< 50,000/mL at baseline

Sponsors & Collaborators

• Queen's Medical Center: lead

Study Sites (1)

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Todd Seto, MD

  The Queen's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 2, 2020
• Study Start: June 12, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)