Coronavirus Disease 2019 (COVID-19)NCT07089680
A Study to Learn About the Study Medicine Paxlovid (Nirmatrelvir + Ritonavir) in Adults Aged 60 and Older Living in Korean Long-term Care Hospitals Who Have COVID-19
An observational study of Coronavirus Disease 2019 (COVID-19), run by Pfizer at 7 sites in South Korea.
Trial summary
The purpose of this study is to learn about the effects of the study medicine (called Paxlovid) for the possible treatment of COVID-19 in older adults who live in long-term care hospitals (LTCHs) in Korea. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Coronavirus Disease 2019 (COVID-19)
- What is being tested?
- Nirmatrelvir/Ritonavir
- How many people
- 937 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 23 Sep 2025to 29 May 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes residents of long-term care hospitals (LTCHs) in Korea who are aged 60 years or older and were diagnosed with COVID-19 between January 14, 2022 and June 1, 2023 (or latest available date). Diagnosis was confirmed by SARS-CoV-2 PCR or antigen test, and symptom onset date was available. Participants were either treated with Paxlovid (Nirmatrelvir/Ritonavir) within 5 days of symptom onset or received no antiviral treatment. Patients were excluded if they received other COVID-19 treatments (e.g., remdesivir, molnupiravir, monoclonal antibodies), had severe renal or hepatic dysfunction, or had contraindicated medications. The study uses retrospective medical chart data and includes follow-up for up to 365 days.
- LTCH residents ≥60 years of age, diagnosed with COVID-19 via SARS-CoV-2 PCR or antigen test, with a symptom onset date (index date) between 14 January 2022 and 1 June 2023 (or latest date available)
- Dispensed Paxlovid within 5 days of COVID-19 symptom onset (Paxlovid treated patients only)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Gangnam-gu Haengbok Convalescence Hospital
Gangnam-gu
The Good Light Hospital
Gwangju, 12748
bobath Memorial Hospital
Gyeonggi-do, 13552
Jeonnam Jeil Hospital
Hwasun-gun
Seocho-Cham Nursing Hospital
Seocho-gu
Incheon Eun-Hye Convalescent Hospital
Seogu
Songdo Hyoja Hospital
Yeonsu-gu
About this study
Official title: IMPACT OF NIRMATRELVIR AND RITONAVIR (PAXLOVID®) ON MORTALITY, PROGRESSION TO SEVERE DISEASE, AND ACTIVITIES OF DAILY LIVING (ADL) WORSENING IN LONG-TERM CARE HOSPITALS (LTCHS) IN KOREA
The purpose of this study is to learn about the effects of the study medicine (called Paxlovid) for the possible treatment of COVID-19 in older adults who live in long-term care hospitals (LTCHs) in Korea. Researchers want to know whether Paxlovid lowers the chance of severe illness or death and helps people carry out their usual daily activities, remain free from aging and weakness, and maintain cognitive function.
This study is seeking participants who:
Read more
- are 60 years of age or older
- live in a long-term care hospital in Korea
- were diagnosed with COVID-19 on or after 14 January 2022, during the period when Paxlovid was available as part of routine care
- received Paxlovid within 5 days after their first COVID-19 symptoms (only for people in the Paxlovid group)
All participants in this study received their usual COVID-19 care. About half also received Paxlovid. Paxlovid was prescribed as part of routine care at the long-term care hospital, typically taken by mouth 2 times a day for 5 days.
The study team will compare the health results of people who received Paxlovid to those who did not, using similar parameters such as age, sex, and medical history. This will help the study team to understand whether Paxlovid makes a meaningful difference in stopping severe illness, death, or slow-down daily functioning.
Participants will not have any extra study visits or tests. The study team will only review information already recorded in their medical charts for up to 1 year after their COVID-19 symptom onset.
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Being tested
- Nirmatrelvir/Ritonavir
- Keywords
- Nirmatrelvir / Ritonavir (Paxlovid), COVID-19, Activities of Daily Living (ADL), Long-Term Care Hospitals, Frailty, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- Medical subject headings
- COVID-19, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nirmatrelvir/RitonavirDrug
Also called Paxlovid
Participants aged 60 years or older residing in long-term care hospitals (LTCHs) in Korea who were diagnosed with COVID-19 and received Paxlovid (Nirmatrelvir/Ritonavir) as part of their clinical care. This group will be assessed for multiple outcomes including mortality, progression to severe disease, worsening of activities of daily living (ADL), and frailty.
| Study group | Role | What they receive |
|---|---|---|
| Paxlovid untreated group | Participants aged 60 years or older residing in long-term care hospitals (LTCHs) in Korea who were diagnosed with COVID-19 but did not receive Paxlovid treatment. This group serves as a comparator to evaluate the effectiveness of Paxlovid on outcomes such as mortality, progression to severe disease, ADL decline, and frailty. | |
| Paxlovid treated group | Participants aged 60 years or older residing in long-term care hospitals (LTCHs) in Korea who were diagnosed with COVID-19 and received Paxlovid (Nirmatrelvir/Ritonavir) as part of their clinical care. This group will be assessed for multiple outcomes including mortality, progression to severe disease, worsening of activities of daily living (ADL), and frailty. Receives: Drug: Nirmatrelvir/Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of progression to severe disease or all-cause mortality within 30 days
Measured: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Secondary outcomes (8)
Change in Activities of Daily Living (ADL) from baseline at 30 days
Measured: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Change in Activities of Daily Living (ADL) from baseline at 90 days
Measured: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Change in Activities of Daily Living (ADL) from baseline at 365 days
Measured: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
All Cause mortality at 30 days by baseline ADL dependency
Measured: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Progression to severe disease at 30 days by baseline ADL dependency
Measured: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
ADL change at 30 days by baseline ADL dependency
Measured: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Subgroup analysis of ADL change at 90 days by baseline ADL dependency
Measured: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Subgroup analysis of ADL change at 365 days by baseline ADL dependency
Measured: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start23 Sep 2025
- Primary completion29 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019 (COVID-19)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 937 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089680
- Sponsor's protocol ID
- C4671064
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT OF NIRMATRELVIR AND RITONAVIR (PAXLOVID®) ON MORTALITY, PROGRESSION TO SEVERE DISEASE, AND ACTIVITIES OF DAILY LIVING (ADL) WORSENING IN LONG-TERM CARE HOSPITALS (LTCHS) IN KOREA
- ClinicalTrials.gov ID
- NCT07089680
- Acronym / sponsor ID
- C4671064
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Keywords
- Nirmatrelvir / Ritonavir (Paxlovid), COVID-19, Activities of Daily Living (ADL), Long-Term Care Hospitals, Frailty, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 937 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 28 Jul 2025 (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.
The purpose of this study is to learn about the effects of the study medicine (called Paxlovid) for the possible treatment of COVID-19 in older adults who live in long-term care hospitals (LTCHs) in Korea. Researchers want to know whether Paxlovid lowers the chance of severe illness or death and helps people carry out their usual daily activities, remain free from aging and weakness, and maintain cognitive function.
This study is seeking participants who:
- are 60 years of age or older
- live in a long-term care hospital in Korea
- were diagnosed with COVID-19 on or after 14 January 2022, during the period when Paxlovid was available as part of routine care
- received Paxlovid within 5 days after their first COVID-19 symptoms (only for people in the Paxlovid group)
All participants in this study received their usual COVID-19 care. About half also received Paxlovid. Paxlovid was prescribed as part of routine care at the long-term care hospital, typically taken by mouth 2 times a day for 5 days.
The study team will compare the health results of people who received Paxlovid to those who did not, using similar parameters such as age, sex, and medical history. This will help the study team to understand whether Paxlovid makes a meaningful difference in stopping severe illness, death, or slow-down daily functioning.
Participants will not have any extra study visits or tests. The study team will only review information already recorded in their medical charts for up to 1 year after their COVID-19 symptom onset.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paxlovid untreated group | – | –Participants aged 60 years or older residing in long-term care hospitals (LTCHs) in Korea who were diagnosed with COVID-19 but did not receive Paxlovid treatment. This group serves as a comparator to evaluate the effectiveness of Paxlovid on outcomes such as mortality, progression to severe disease, ADL decline, and frailty. |
| Paxlovid treated group | – | Drug: Nirmatrelvir/RitonavirParticipants aged 60 years or older residing in long-term care hospitals (LTCHs) in Korea who were diagnosed with COVID-19 and received Paxlovid (Nirmatrelvir/Ritonavir) as part of their clinical care. This group will be assessed for multiple outcomes including mortality, progression to severe disease, worsening of activities of daily living (ADL), and frailty. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes residents of long-term care hospitals (LTCHs) in Korea who are aged 60 years or older and were diagnosed with COVID-19 between January 14, 2022 and June 1, 2023 (or latest available date). Diagnosis was confirmed by SARS-CoV-2 PCR or antigen test, and symptom onset date was available. Participants were either treated with Paxlovid (Nirmatrelvir/Ritonavir) within 5 days of symptom onset or received no antiviral treatment. Patients were excluded if they received other COVID-19 treatments (e.g., remdesivir, molnupiravir, monoclonal antibodies), had severe renal or hepatic dysfunction, or had contraindicated medications. The study uses retrospective medical chart data and includes follow-up for up to 365 days.
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: PaxlovidParticipants aged 60 years or older residing in long-term care hospitals (LTCHs) in Korea who were diagnosed with COVID-19 and received Paxlovid (Nirmatrelvir/Ritonavir) as part of their clinical care. This group will be assessed for multiple outcomes including mortality, progression to severe disease, worsening of activities of daily living (ADL), and frailty. | Drug | Paxlovid treated group |
Primary outcome
Composite outcome of progression to severe disease or all-cause mortality within 30 days
Time frame: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
8 secondary outcomes
Change in Activities of Daily Living (ADL) from baseline at 30 days
Time frame: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Change in Activities of Daily Living (ADL) from baseline at 90 days
Time frame: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Change in Activities of Daily Living (ADL) from baseline at 365 days
Time frame: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
All Cause mortality at 30 days by baseline ADL dependency
Time frame: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Progression to severe disease at 30 days by baseline ADL dependency
Time frame: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
ADL change at 30 days by baseline ADL dependency
Time frame: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Subgroup analysis of ADL change at 90 days by baseline ADL dependency
Time frame: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Subgroup analysis of ADL change at 365 days by baseline ADL dependency
Time frame: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease 2019 (COVID-19), run by Pfizer at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite outcome of progression to severe disease or all-cause mortality within 30 days (time frame: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)). 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 14 Aug 2026.