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)
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ClinicalTrials.gov Identifier: NCT04409262 |
Recruitment Status :
Active, not recruiting
First Posted : June 1, 2020
Last Update Posted : January 11, 2021
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 Pneumonia | Drug: Remdesivir Drug: Tocilizumab Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 650 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia |
Actual Study Start Date : | June 16, 2020 |
Estimated Primary Completion Date : | February 12, 2021 |
Estimated Study Completion Date : | March 16, 2021 |

Arm | Intervention/treatment |
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Experimental: Remdesivir + Tocilizumab (RDV+TCZ)
Participants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1.
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Drug: Remdesivir
Participants will receive intravenous (IV) RDV Drug: Tocilizumab Participants will receive IV TCZ |
Active Comparator: Remdesivir + Placebo (RDV+Placebo)
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.
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Drug: Remdesivir
Participants will receive intravenous (IV) RDV Drug: Placebo Participants will receive IV placebo matched to TCZ |
- Time from administration of tocilizumab/placebo to hospital discharge or "ready for discharge," Defined as a Score of 1 on a 7-point Ordinal Scale [ Time Frame: Up to Day 28 ]
- Time to mechanical ventilation or death, defined as the time from administration of tocilizumab/placebo to the first occurrence of mechanical ventilation or death (whichever occurs first) [ Time Frame: Up to Day 28 ]
- Time to improvement, defined as the time from administration of tocilizumab/placebo to an improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status [ Time Frame: Up to Day 28 ]
- Clinical Status as Assessed by the Investigator Using a 7-Category Ordinal Scale of Clinical Status on Days 7, 14, 21, 28, and 60 [ Time Frame: Days 7, 14, 21, 28, and 60 ]
- Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline up to Day 28 and Day 60 [ Time Frame: Up to Day 28 and Day 60 ]
- Proportion of participants who are alive and free of respiratory failure at (participants requiring ventilation at baseline) up to Day 28 and Day 60 [ Time Frame: Up to Day 28 and Day 60 ]
- Duration of Mechanical Ventilation (participants requiring mechanical ventilation at baseline) [ Time Frame: Up to Day 60 ]
- Time to death up to Days 28 and 60 [ Time Frame: Up to Day 28 and Day 60 ]
- Mortality Rate on Days 14, 28, and 60 [ Time Frame: Days 14, 28, and 60 ]
- Time to recovery, defined as time from administration of tocilizumab/placebo to the time when a category of 2, non-ICU hospital ward (or "ready for hospital ward") not requiring supplemental oxygen, or better is observed [ Time Frame: Up to Day 28 ]
- Percentage of Participants with Adverse Events (AEs) Tabulated by Severity [ Time Frame: Up to 60 days ]
- Proportion of Participants with any Post-Treatment Infection [ Time Frame: Up to 60 days ]
- Plasma Concentration of Remdesivir [ Time Frame: Days 4 and 7 ]

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409262

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT04409262 |
Other Study ID Numbers: |
WA42511 2020-002275-34 ( EudraCT Number ) |
First Posted: | June 1, 2020 Key Record Dates |
Last Update Posted: | January 11, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |