Trial Profile
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
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 05 Apr 2023
Price :
$35
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At a glance
- Drugs Remdesivir (Primary) ; Tocilizumab (Primary)
- Indications COVID-19 pneumonia
- Focus Registrational; Therapeutic Use
- Acronyms REMDACTA
- Sponsors Genentech; Roche
- 22 Feb 2023 Results assessing estimated dose exposure metrics of RDV and metabolites (GS-704277, GS-441524) in REDPINE (n=90) study compared to PINETREE (n=148) and REMDACTA(n=289) study participants presented at the 30th Conference on Retroviruses and Opportunistic Infections 2023
- 04 Apr 2022 According to a Genentech media release, the U.S. FDA has accepted the company's supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
- 04 Apr 2022 According to a Genentech media release, a decision on U.S. FDA approval is expected in the second half of this year.