COVID-19NCT05387369
A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19
An observational study of COVID-19, run by Huashan Hospital at 1 site in China.
Trial summary
The study was designed to analyze the efficacy and safety of Paxlovid for the treatment of COVID-19. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Paxlovid
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2022to 30 Mar 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with COVID-19 who were admitted to Huashan Hospital, Fudan University from 2022 to 2027
Who may be able to join
- Participants who have a positive SARS-CoV-2 test result;
- Participants who have one or more mild or moderate COVID-19 symptoms.
Who cannot join
- No specific exclusion criteria in this real world study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai
Jiming Zhang, M.D., +86 021-52887948, jmzhang@vip.126.com
Jiming Zhang, PhD
About this study
The study was designed to analyze the efficacy and safety of Paxlovid for the treatment of COVID-19.
Read the detailed description
The study is a real-world study and the case records of patients with COVID-19 who visit Huashan Hospital affiliated to Fudan University from 2022 to 2027 and receive Paxlovid therapy will be collected in this study. The medical data including patient demographic, clinical characteristics, laboratory examination, history of treatments, adverse reactions and treatment outcome will be extracted to analyze the effectivity and safety of paxlovid and explore the prognosis-relevant factors of COVID-19.
- Conditions
- COVID-19
- Being tested
- Paxlovid
- Keywords
- paxlovid
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaxlovidDrug
The study is a real-world study. According to the actual medical history of patients, the usage of paxlovid will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Paxlovid | Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive Paxlovid therapy Receives: Drug: Paxlovid | |
| Routine therapy | Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive routine therapy without paxlovid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral shedding time
time from the first positive testing to the first day of nucleic acid Ct value> 35 for both ORF1ab and N gene (in two consecutive).
Measured: up to 28 days
Percentage of the participants who have progression of COVID-19
Percentage of participants who experience these events by Day 28 Progress to severe and/or critical COVID-19; Death from any cause
Measured: up to 28 days
Secondary outcomes (3)
AEs and SAEs through Day 28
Adverse events and Serious adverse events through Day 28
Measured: up to 28 days
Percentage of participants who turned negative for SARS-CoV-2
Percentage of participants who turned negative for SARS-COV-2 at Day 3, 5, 7, 10, 14
Measured: up to 28 days
Time to sustained clinical recovery
Time to sustained clinical recovery
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start21 Mar 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2027 (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.
- More trials run by Huashan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiming Zhang, Huashan Hospital
- Investigators
- Feng Sun, MD, Principal investigator, Huashan Hospital affliatied to Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387369
- Sponsor's protocol ID
- KY2022-552
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19
- ClinicalTrials.gov ID
- NCT05387369
- Acronym / sponsor ID
- KY2022-552
- Conditions
- COVID-19
- Keywords
- paxlovid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 24 May 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.
The study was designed to analyze the efficacy and safety of Paxlovid for the treatment of COVID-19.
Detailed description
The study is a real-world study and the case records of patients with COVID-19 who visit Huashan Hospital affiliated to Fudan University from 2022 to 2027 and receive Paxlovid therapy will be collected in this study. The medical data including patient demographic, clinical characteristics, laboratory examination, history of treatments, adverse reactions and treatment outcome will be extracted to analyze the effectivity and safety of paxlovid and explore the prognosis-relevant factors of COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paxlovid | – | Drug: PaxlovidPatients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive Paxlovid therapy |
| Routine therapy | – | –Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive routine therapy without paxlovid |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with COVID-19 who were admitted to Huashan Hospital, Fudan University from 2022 to 2027
Key inclusion criteria (2 listed)
- Participants who have a positive SARS-CoV-2 test result;
- Participants who have one or more mild or moderate COVID-19 symptoms.
Key exclusion criteria (1 listed)
- No specific exclusion criteria in this real world study.
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 |
|---|---|---|
| PaxlovidThe study is a real-world study. According to the actual medical history of patients, the usage of paxlovid will be collected. | Drug | Paxlovid |
Primary outcome
Viral shedding time
Time frame: up to 28 days
time from the first positive testing to the first day of nucleic acid Ct value> 35 for both ORF1ab and N gene (in two consecutive).
Percentage of the participants who have progression of COVID-19
Time frame: up to 28 days
Percentage of participants who experience these events by Day 28 Progress to severe and/or critical COVID-19; Death from any cause
3 secondary outcomes
AEs and SAEs through Day 28
Time frame: up to 28 days
Percentage of participants who turned negative for SARS-CoV-2
Time frame: up to 28 days
Time to sustained clinical recovery
Time frame: up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 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.
Feng Sun, MD principal investigator
Huashan Hospital affliatied to Fudan University
1 site 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 Huashan 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 May 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Sun, MD (+86 02152889999, aaronsf1125@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral shedding time (time frame: up to 28 days). The study lists 2 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 24 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.