A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia (REMDACTA)

Roche

Status and phase: Completed; Phase 3

Conditions: COVID-19 Pneumonia

Treatments: Drug: Placebo; Drug: Tocilizumab; Drug: Remdesivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT04409262

2020-002275-34 (EudraCT Number)

WA42511

Details and patient eligibility

About

This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19 pneumonia.

Enrollment: 649 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Hospitalized with COVID-19 pneumonia confirmed per a positive polymerase chain reaction (PCR) of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
• Requiring more than 6 L/min supplemental oxygen to maintain SpO2 > 93%
• Agrees to not participate in another clinical trial for the treatment of COVID-19 while participating in this study

Exclusion Criteria

• Known severe allergic reactions to tocilizumab or other monoclonal antibodies
• Known hypersensitivity to remdesivir, the metabolites, or formulation excipients
• 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
• Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months
• Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 within 24 hours prior to study drug dosing. In addition, participants with prior or current treatment with > 2 doses of remdesivir for COVID-19 are excluded
• Participating in other drug clinical trials
• Estimated glomerular filtration rate (eGFR) < 30 mL/min (including patients receiving hemodialysis or hemofiltration)
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours of screening (according to local laboratory reference ranges)
• Absolute neutrophil count (ANC) < 1000/uL at screening
• Platelet count < 50,000/uL at screening
• Body weight < 40 kg
• Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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649 participants in 2 patient groups

Remdesivir + Tocilizumab (RDV+TCZ)

Experimental group

Description:

Participants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1.

Treatment:

Drug: Tocilizumab

Drug: Remdesivir

Remdesivir + Placebo (RDV+Placebo)

Active Comparator group

Description:

Participants assigned to the RDV+ placebo arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ-placebo on Day 1.

Treatment:

Drug: Remdesivir

Drug: Placebo