COVID-19 PneumoniaNCT05532852
Efficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study
A study testing standard-of-care plus Paxlovid and standard-of-care in people with COVID-19 Pneumonia, run by Ruijin Hospital at 1 site in China.
Trial summary
COVID-19 is currently one of the serious public health challenges worldwide, and there is a great need to develop effective treatments. Paxlovid is a Pfizer-developed oral new drug for the treatment of COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- standard-of-care plus Paxlovid and standard-of-care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 728 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to Oct 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patients with confirmed COVID-19 who had taken more than one dose of Paxlovid.
Who cannot join
- Age < 18 years-old;
- Pregnancy;
- Data missing > 20%.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Medical School of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200025
Jieming Qu, MD, PhD, 86-21-64370045, jmqu0906@163.com
About this study
COVID-19 is currently one of the serious public health challenges worldwide, and there is a great need to develop effective treatments. Paxlovid is a Pfizer-developed oral new drug for the treatment of COVID-19. Paxlovid, which is used to treat adult patients with mild to moderate COVID-19 who have high-risk factors for progression to severe disease, was conditionally approved for marketing in the United States and China in December 2021 and February 2022, respectively. Clinical trials have shown that this drug can significantly reduce the progression from mild to severe disease and the rate of hospitalization and mortality. However, due to the limitations of clinical trials in the subject selection, there is still insufficient knowledge about the efficacy and safety of Paxlovid in a real-world population. Relevant studies on this drug in real-world people, especially in Chinese populations, have not been reported. Therefore, this study was designed to investigate the efficacy and safety of Paxlovid on sufferers of COVID-19 through a retrospective, real-world analysis.
- Conditions
- COVID-19 Pneumonia
- Being tested
- standard-of-care plus Paxlovid, standard-of-care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard-of-care plus PaxlovidDrug
standard-of-care plus Paxlovid
standard-of-careDrug
standard-of-care
| Study group | Role | What they receive |
|---|---|---|
| standard-of-care | Sham comparator | Not described Receives: Drug: standard-of-care |
| standard-of-care plus Paxlovid | Experimental | Not described Receives: Drug: standard-of-care plus Paxlovid |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
the mortality of the subjects within 28 days since the diagnosis of COVID-19
Measured: 28 days since the diagnosis of COVID-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Jul 2022
- Primary completionJun 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 728 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieming QU, Ruijin Hospital
- Investigators
- Jieming Qu, Principal investigator, Rui-jin Hospital, Shanghai Jiao-tong University School of Medicine, Shanghai,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532852
- Sponsor's protocol ID
- KY01004
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study
- ClinicalTrials.gov ID
- NCT05532852
- Acronym / sponsor ID
- KY01004
- Conditions
- COVID-19 Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 728 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 8 Sep 2022 (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.
COVID-19 is currently one of the serious public health challenges worldwide, and there is a great need to develop effective treatments. Paxlovid is a Pfizer-developed oral new drug for the treatment of COVID-19. Paxlovid, which is used to treat adult patients with mild to moderate COVID-19 who have high-risk factors for progression to severe disease, was conditionally approved for marketing in the United States and China in December 2021 and February 2022, respectively. Clinical trials have shown that this drug can significantly reduce the progression from mild to severe disease and the rate of hospitalization and mortality. However, due to the limitations of clinical trials in the subject selection, there is still insufficient knowledge about the efficacy and safety of Paxlovid in a real-world population. Relevant studies on this drug in real-world people, especially in Chinese populations, have not been reported. Therefore, this study was designed to investigate the efficacy and safety of Paxlovid on sufferers of COVID-19 through a retrospective, real-world analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard-of-care | Sham comparator | Drug: standard-of-care |
| standard-of-care plus Paxlovid | Experimental | Drug: standard-of-care plus Paxlovid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with confirmed COVID-19 who had taken more than one dose of Paxlovid.
Key exclusion criteria (3 listed)
- Age < 18 years-old;
- Pregnancy;
- Data missing > 20%.
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 |
|---|---|---|
| standard-of-care plus Paxlovidstandard-of-care plus Paxlovid | Drug | standard-of-care plus Paxlovid |
| standard-of-carestandard-of-care | Drug | standard-of-care |
Primary outcome
28-day mortality
Time frame: 28 days since the diagnosis of COVID-19
the mortality of the subjects within 28 days since the diagnosis of COVID-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Jieming Qu principal investigator
Rui-jin Hospital, Shanghai Jiao-tong University School of Medicine, Shanghai,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard-of-care plus Paxlovid and standard-of-care in people with COVID-19 Pneumonia, run by Ruijin Hospital at 1 site in China.
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 1 inclusion and 3 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 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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?
Contact Jieming Qu, PhD (+862164370045, jmqu0906@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 days since the diagnosis of COVID-19). 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 8 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.