COVID-19ESOA-19NCT05894603
Effectiveness and Safety of New Oral Antivirals for COVID-19
An observational study of COVID-19, run by Universidade do Porto at 6 sites in Portugal.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Nirmatrelvir/ritonavir and Molnupiravir
- How many people
- 211 participants
- Where
- 6 sitesPortugal
- Study dates
- 1 Aug 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving the oral antivirals against COVID-19 - Paxlovid® or Lagevrio®.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Portugal6 sites
Hospital do Divino Espírito Santo de Ponta Delgada, EPE
Açores
Centro Hospitalar de Lisboa Ocidental, EPE
Lisbon
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
Porto
Centro Hospitalar e Universitário de São João, EPE
Porto
Centro Hospitalar Universitário de Santo António, EPE
Porto
Unidade de Saúde Familiar - Homem do Leme (ACES Porto Ocidental)
Porto
About this study
Official title: Post-marketing Surveillance Study of the Effectiveness and Safety of New Oral Antivirals for Outpatients With Mild-moderate COVID-19
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.
Read the detailed 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 task6.
A real-life cohort event monitoring system allows for the monitoring of newly introduced oral antivirals, in addition to existing spontaneous reporting systems and healthcare database studies (i.e., secondary data), as it is complementary to these systems in several ways. First, it is better suited to capture the more frequent AE, including those that are not medically attended. It generates more comprehensive safety data, e.g. on disease course and the impact of the AE. Moreover, there is insufficient data on these new medicines in real clinical practice, particularly from large-scale studies on the long-term efficacy or safety.
This work, with scientific and academic interest but, essentially, clinical and regulatory importance, constitutes a duty of the regional pharmacovigilance units. As such, it is also an obligation of the Pharmacy and Therapeutics Commissions, based on the legislation in force, to "collaborate in studies to monitor the safety and effectiveness of medicines promoted in the context of the National Pharmacovigilance System".
- Conditions
- COVID-19
- Being tested
- Nirmatrelvir/ritonavir, Molnupiravir
- Keywords
- Post-marketing surveillance, COVID-19, Antivirals, Effectiveness, Safety
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nirmatrelvir/ritonavirDrug
Also called Paxlovid
Nirmatrelvir/ritonavir
MolnupiravirDrug
Also called Lagevrio
Molnupiravir
| Study group | Role | What they receive |
|---|---|---|
| Oral antiviral A | Patients with an indication for treatment with nirmatrelvir + ritonavir (Paxlovid®). Receives: Drug: Nirmatrelvir/ritonavir | |
| Oral antiviral B | Patients with an indication for treatment with molnupiravir (Lagevrio®). Receives: Drug: Molnupiravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 29 days after treatment onset for both drugs.
Secondary outcomes (1)
Adherence to treatment
Will be measured using the self-reported 7-item Measure Treatment Adherence (MTA) tool validated for the Portuguese Population. The MTA is a psychometric tool derived from the Morisky et al. questionnaire and evaluates the individuals' behaviour concerning the daily use of medication.
Measured: 6 days after onset treatment for both drugs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Aug 2022
- Primary completion31 Jan 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde
- Responsible party
- Sponsor
- Investigators
- Jorge Junqueira Polónia, MD, PhD, Study director, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894603
- Sponsor's protocol ID
- ESOA-19
- Other IDs
- EUPAS48186
- Acronym
- ESOA-19
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance Study of the Effectiveness and Safety of New Oral Antivirals for Outpatients With Mild-moderate COVID-19
- ClinicalTrials.gov ID
- NCT05894603
- Acronym / sponsor ID
- ESOA-19 / ESOA-19
- Conditions
- COVID-19
- Keywords
- Post-marketing surveillance, COVID-19, Antivirals, Effectiveness, Safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 task6.
A real-life cohort event monitoring system allows for the monitoring of newly introduced oral antivirals, in addition to existing spontaneous reporting systems and healthcare database studies (i.e., secondary data), as it is complementary to these systems in several ways. First, it is better suited to capture the more frequent AE, including those that are not medically attended. It generates more comprehensive safety data, e.g. on disease course and the impact of the AE. Moreover, there is insufficient data on these new medicines in real clinical practice, particularly from large-scale studies on the long-term efficacy or safety.
This work, with scientific and academic interest but, essentially, clinical and regulatory importance, constitutes a duty of the regional pharmacovigilance units. As such, it is also an obligation of the Pharmacy and Therapeutics Commissions, based on the legislation in force, to "collaborate in studies to monitor the safety and effectiveness of medicines promoted in the context of the National Pharmacovigilance System".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral antiviral A | – | Drug: Nirmatrelvir/ritonavirPatients with an indication for treatment with nirmatrelvir + ritonavir (Paxlovid®). |
| Oral antiviral B | – | Drug: MolnupiravirPatients with an indication for treatment with molnupiravir (Lagevrio®). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving the oral antivirals against COVID-19 - Paxlovid® or Lagevrio®.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nirmatrelvir/ritonavirAlso: PaxlovidNirmatrelvir/ritonavir | Drug | Oral antiviral A |
| MolnupiravirAlso: LagevrioMolnupiravir | Drug | Oral antiviral B |
Primary outcome
Safety outcome
Time frame: 6 days after onset treatment for both drugs.
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.
Safety outcome
Time frame: 39 days after treatment onset for nirmatrelvir/ritonavir cohort.
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.
Safety outcome
Time frame: 19 days after treatment onset for molnupiravir cohort.
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.
Effectiveness outcome
Time frame: 29 days after treatment onset for both drugs.
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.
1 secondary outcome
Adherence to treatment
Time frame: 6 days after onset treatment for both drugs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Junqueira Polónia, MD, PhD study director
Universidade do Porto
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Universidade do Porto at 6 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcome (time frame: 6 days after onset treatment for both drugs.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.