MedTrace Logo

Effectiveness and Safety of New Oral Antivirals for COVID-19

NCT05894603 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 211

Last updated 2023-12-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Nirmatrelvir/ritonavir

Nirmatrelvir/ritonavir

DRUG

Molnupiravir

Molnupiravir

Sponsors & Collaborators

  • Centro de Investigação em Tecnologias e Serviços de Saúde

    collaborator OTHER

  • Rede de Investigação em Saúde

    collaborator OTHER

  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Jorge Junqueira Polónia, MD, PhD · Universidade do Porto

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2024-01-31
Completion
2024-06-30

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05894603 on ClinicalTrials.gov