Phase 3
Completed N=649
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
Source: ClinicalTrials.gov NCT04409262 ↗Enrolled (actual)
649
Serious AEs
33.8%
Results posted
Feb 2022
Primary outcomePrimary: Time to Hospital Discharge or "Ready for Discharge" up to Day 28 — 14.0; 14.0 days — p=0.7414
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Hospital Discharge or "Ready for Discharge" up to Day 28 |
14.0; 14.0 | 0.7414 |
| SECONDARY Time to Mechanical Ventilation or Death up to Day 28 |
NA; NA | 0.8993 |
| SECONDARY Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 14 |
52.4; 54.0; 1.9; 2.6; 11.4; 8.9 | 0.7648 |
| SECONDARY Time to Death up to Day 28 |
NA; NA | 0.7867 |
| SECONDARY Time to Death up to Day 60 |
NA; NA | 0.4602 |
| SECONDARY Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-category Ordinal Scale of Clinical Status up to Day 28 |
11.0; 12.0 | 0.8664 |
| SECONDARY Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 7 |
21.9; 19.4; 4.3; 5.6; 17.6; 20.1 | 0.9569 |
| SECONDARY Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 21 |
62.4; 64.3; 1.4; 1.2; 4.8; 4.7 | 0.6331 |
| SECONDARY Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 28 |
67.1; 66.4; 1.4; 1.4; 1.0; 3.5 | 0.9622 |
| SECONDARY Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 60 |
70.0; 72.2; 1.4; 0.7; 1.0; 1.4 | 0.4850 |
| SECONDARY Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline (Participants Who Did Not Require Mechanical Ventilation at Baseline) |
29.8; 27.5; 31.4; 28.8 | 0.5915 |
| SECONDARY Proportion of Participants Who Are Alive and Free of Respiratory Failure at Day 28 and Day 60 (Participants Requiring Mechanical Ventilation at Baseline) |
54.5; 40.7; 63.6; 47.5 | 0.2590 |
| SECONDARY Duration of Mechanical Ventilation (Participants Requiring Mechanical Ventilation at Baseline) up to Day 28 |
16.7; 19.6 | 0.2434 |
| SECONDARY Difference in Mortality at Days 14, 28, and 60 |
9.5; 10.0; 19.5; 18.1; 25.7; 22.6 | 0.8222 |
| SECONDARY Time to Recovery up to Day 28 |
13.0; 13.0 | 0.6778 |
| SECONDARY Proportion of Participants Who Are Discharged or "Ready for Discharge" up to Day 28 |
67.1; 66.0 | 0.7692 |
| SECONDARY Proportion of Participants Who Require Initiation of Mechanical Ventilation Post-baseline or Die up to Day 28 |
29.0; 28.6 | 0.9334 |
Eligibility 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) 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
Data sourced from ClinicalTrials.gov (NCT04409262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.