Study identification

EU PAS number

EUPAS48186

Study ID

49575

Official title and acronym

Post-marketing Surveillance Study of the Effectiveness and Safety of new Oral Antivirals for outpatients with mild-moderate COVID-19. (ESOA-19)

DARWIN EU® study

No

Study countries

Portugal

Study description

There is an increased lack of short- and long-term real-life effectiveness and safety data on new oral antivirals authorised and commercialised to treat COVID-19.
To date, only two clinical trials have been published with data on the efficacy and safety of the use of the Paxlovid® and Lagevrio®.
Since there is a public health, political, social and economic pressure to prevent severity, hospitalisation and death from COVID-19, monitoring the effectiveness and safety of commercialised oral antiviral therapies against COVID-19 has become emergent pharmacovigilance and public health task.
The objective of the study is to monitor the post-marketing safety and effectiveness of the new oral antivirals indicated for the treatment of COVID-19, namely Nirmatrelvir/Ritonavir (Paxlovid®) and Molnupiravir (Lagevrio®), having as holders of the Authorization of Market introduction to Pfizer Europe MA EEIG and Merck Sharp & Dohme B.V., respectively.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Renato Ferreira da Silva

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
EU institutional research programme

More details on funding

Portuguese national funds and Community funds from the European Social Fund (ESF) through FCT – Fundação para a Ciência e a Tecnologia (Portugal)).
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable