Effectiveness and Safety of New Oral Antivirals for COVID-19

NCT05894603 | Unknown

• 2 other identifiers: ESOA-19EUPAS48186
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 6

Brief 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

COVID-19

Keywords

Post-marketing surveillance; COVID-19; Antivirals; Effectiveness; Safety

Outcome Measures

Primary Outcomes (4)

• Safety outcome

  The incidence of AE (with particular focus on AE of special interest) that emerge during or after the treatment period, serious AE, and AE leading to discontinuation of the treatment, as coded according to the MedDRA. Incidence data will be provided for each treatment group within the safety analysis population, including all patients who received at least one drug dose. The occurrence of AE will be asked in open question / unsolicited. For each reported AE, date of onset, outcome, duration of symptoms (if recovered), and severity/impact of the symptoms (including medical assistance \& hospitalisation) will be asked.

  6 days after onset treatment for both drugs.

• Safety outcome

  The incidence of AE (with particular focus on AE of special interest) that emerge during or after the treatment period, serious AE, and AE leading to discontinuation of the treatment, as coded according to the MedDRA. Incidence data will be provided for each treatment group within the safety analysis population, including all patients who received at least one drug dose. The occurrence of AE will be asked in open question / unsolicited. For each reported AE, date of onset, outcome, duration of symptoms (if recovered), and severity/impact of the symptoms (including medical assistance \& hospitalisation) will be asked.

  39 days after treatment onset for nirmatrelvir/ritonavir cohort.

• Safety outcome

  The incidence of AE (with particular focus on AE of special interest) that emerge during or after the treatment period, serious AE, and AE leading to discontinuation of the treatment, as coded according to the MedDRA. Incidence data will be provided for each treatment group within the safety analysis population, including all patients who received at least one drug dose. The occurrence of AE will be asked in open question / unsolicited. For each reported AE, date of onset, outcome, duration of symptoms (if recovered), and severity/impact of the symptoms (including medical assistance \& hospitalisation) will be asked.

  19 days after treatment onset for molnupiravir cohort.

• Effectiveness outcome

  The incidence of hospitalisation for any cause (defined as ≥24 hours of acute care in a hospital or any similar facility) or death for any cause through day 29.

  29 days after treatment onset for both drugs.

Secondary Outcomes (1)

• Adherence to treatment

  6 days after onset treatment for both drugs.

Study Arms (2)

Oral antiviral A

Patients with an indication for treatment with nirmatrelvir + ritonavir (Paxlovid®).

Drug: Nirmatrelvir/ritonavir

Oral antiviral B

Patients with an indication for treatment with molnupiravir (Lagevrio®).

Drug: Molnupiravir

Interventions

Nirmatrelvir/ritonavir DRUG

Nirmatrelvir/ritonavir

Also known as: Paxlovid

Oral antiviral A

Molnupiravir DRUG

Molnupiravir

Also known as: Lagevrio

Oral antiviral B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving the oral antivirals against COVID-19 - Paxlovid® or Lagevrio®.

You may qualify if:

• Participants eligible to be included in the study are identified by medical prescribing of one of the drugs under study, and either the medicine recipient or their proxy should:
• Comply with the eligibility criteria for prescribing these drugs (including patients ≥ 18 years old), according to Norm nr 005/2022 of the General Directorate of Health of Portugal\*;
• Enrol in the study within the first 72 hours after dispensing treatment;
• Be able to understand the Portuguese language;
• Available for follow-up during study time;
• Provide informed consent.
• Compliance with the eligibility criteria for prescribing these drugs is the sole responsibility of the prescriber who assesses the patient, so the study centres only include patients referred by the prescriber.

You may not qualify if:

• Will be considered ineligible participants those who:
• Are not available for follow-up and monitoring;
• Participate in phase I, II, III or IV clinical trials;
• Life expectancy is less than one month.

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro de Investigação em Tecnologias e Serviços de Saúde: collaborator
• Rede de Investigação em Saúde: collaborator

Study Sites (6)

Hospital do Divino Espírito Santo de Ponta Delgada, EPE

Açores, Portugal

Location

Centro Hospitalar de Lisboa Ocidental, EPE

Lisbon, Portugal

Location

Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

Porto, Portugal

Location

Centro Hospitalar e Universitário de São João, EPE

Porto, Portugal

Location

Centro Hospitalar Universitário de Santo António, EPE

Porto, Portugal

Location

Unidade de Saúde Familiar - Homem do Leme (ACES Porto Ocidental)

Porto, Portugal

Location

MeSH Terms

Conditions

COVID-19

Interventions

nirmatrelvir and ritonavir drug combination; molnupiravir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jorge Junqueira Polónia, MD, PhD

  Universidade do Porto

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 8, 2023
• Study Start: August 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: June 30, 2024
• Last Updated: December 18, 2023

Record last verified: 2023-05

Locations

PT (6)