The COVID-19 page published on our website is now updated!
It collects all the clinical trials currently launched worldwide for COVID-19 including further detailed information on the trials.
Particular attention should be paid to clinical trials that investigate the efficacy and safety of Remdesivir, one of the candidate interventions evaluated for the treatment of COVID-19.
Currently 16 studies on Remdesivir have been registered on the international and national registries. Most of the studies are phase III randomised controlled studies.
These efforts have been paid off! A good news has been shared: the EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (Remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen.
Data on Remdesivir were assessed in a short timeframe through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available. Under normal circumstances, all data supporting a marketing authorisation application must be submitted at the start of the evaluation procedure.
The EMA recommendation is mainly based on data from the study NIAID-ACTT-1, a phase III randomised placebo-controlled trial, sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), plus supporting data from the other studies on Remdesivir that we analysed for our COVID-19 page.
Further efficacy and safety data will be collected through the ongoing studies and post-marketing reports and will be regularly reviewed by the CHMP and EMA’s safety committee (PRAC).
Stay tuned and do not miss further updates on the COVID-19 page.