COVID-19NCT05792865
A Registry Study of Patients Hospitalized With Confirmed COVID-19
An observational study of COVID-19, run by Beijing Chao Yang Hospital.
Trial summary
The design of this registered study aims to evaluate the efficacy and safety of Paxlovid in the treatment of hospitalized COVID-19 patients, and to explore factors related to the efficacy and safety of Paxlovid. 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?
- paxlovid and No paxlovid
- How many people
- 488 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2023to 30 Dec 2023
- How long will I take part?
- 28 Days
- 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: This study will focus on COVID-19 infected patients who are admitted to the Beijing Chaoyang Hospital, affiliated with Capital Medical University, from November 15th, 2022 to March 30th, 2023.
Who may be able to join
- Confirmed diagnosis of COVID-19 infection.
- Presence of at least one high-risk factor, including age ≥60 years, diabetes, hypertension, cardiovascular disease, stroke, chronic liver or kidney disease, cancer, history of smoking or obesity.
Who cannot join
- No specific exclusion criteria in this study.
Trial locations and contacts
No sites are listed yet.
About this study
The design of this registered study aims to evaluate the efficacy and safety of Paxlovid in the treatment of hospitalized COVID-19 patients, and to explore factors related to the efficacy and safety of Paxlovid.
- Conditions
- COVID-19
- Being tested
- paxlovid, No paxlovid
- Keywords
- Hospitalized, 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
Also called paxlovid within initial 5 days
Patients treated with PAXLOVID within 5 days of being diagnosed with covid-19 will be included in this group. Patients treated with PAXLOVID will be included in this group. This study is a non-interventional observational study, and no intervention measures were applied to the clinical diagnosis and treatment process of hospitalized COVID-19 patients. The use of Paxlovid is completely decided by the clinical doctors based on the patients' condition and clinical experience.
No paxlovidDrug
Patients not treated with PAXLOVID will be included in this group. This study is a non-interventional observational study, and no intervention measures were applied to the clinical diagnosis and treatment process of hospitalized COVID-19 patients. The use of Paxlovid is completely decided by the clinical doctors based on the patients' condition and clinical experience.
PaxlovidDrug
Also called Paxlovid outside of the initial 5 days
Patients treated with PAXLOVID outside of the initial 5 days after being diagnosed with covid-19 will be included in this group.
| Study group | Role | What they receive |
|---|---|---|
| Paxlovid（Within 5 days after the diagnosis of COVID-19） | According to the patient's medical records, the time from the diagnosis of COVID-19 to the prescription of PAXLOVID is within 5 days. Receives: Drug: paxlovid | |
| Paxlovid （More than 5 days after the diagnosis of COVID-19） | According to the patient's medical records, the time from the diagnosis of COVID-19 to the prescription of PAXLOVID exceeds 5 days. Receives: Drug: Paxlovid | |
| No paxlovid used | Patients have never used Paxlovid after being diagnosed with COVID-19, whether before or after hospitalization. Receives: Drug: No paxlovid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression rates
The proportion of patients who experienced any of the following events within 28 days after being diagnosed with COVID-19, including all-cause mortality, requiring invasive mechanical ventilation, or being admitted to the intensive care unit.
Measured: up to 28 days
Secondary outcomes (5)
all-cause deaths rates
The proportion of patients who experienced all-cause mortality within 28 days after being diagnosed with COVID-19.
Measured: up to 28 days
rehospitalization event rates
The proportion of patients who experienced a rehospitalization event within 28 days after being diagnosed with COVID-19
Measured: up to 28 days
COVID-19 repositive event rates
The proportion of patients who experienced a COVID-19 repositive event within 28 days after being diagnosed with COVID-19
Measured: up to 28 days
adverse drug reaction event
The proportion of patients who experienced any adverse drug reaction events within 28 days after being diagnosed with COVID-19.
Measured: up to 28 days
thromboembolic event rates
The proportion of patients who experienced thromboembolic events, including deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction, within 28 days after being diagnosed with COVID-19.
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 posted31 Mar 2023
- Study start30 Mar 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2023 (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 Beijing Chao Yang 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
- 488 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Yi, Beijing Chao Yang Hospital
- Investigators
- Yi Zhang, PhD, Principal investigator, Beijing Chao Yang HospitalZhuoling An, PhD, Principal investigator, Beijing Chao Yang HospitalChaohui Tong, PhD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792865
- Sponsor's protocol ID
- CYH-PHARM1
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2023
- Last updated
- 31 Mar 2023
- 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 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study of Patients Hospitalized With Confirmed COVID-19
- ClinicalTrials.gov ID
- NCT05792865
- Acronym / sponsor ID
- CYH-PHARM1
- Conditions
- COVID-19
- Keywords
- Hospitalized, paxlovid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 30 Mar 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 31 Mar 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.
The design of this registered study aims to evaluate the efficacy and safety of Paxlovid in the treatment of hospitalized COVID-19 patients, and to explore factors related to the efficacy and safety of Paxlovid.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 28 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paxlovid（Within 5 days after the diagnosis of COVID-19） | – | Drug: paxlovidAccording to the patient's medical records, the time from the diagnosis of COVID-19 to the prescription of PAXLOVID is within 5 days. |
| Paxlovid （More than 5 days after the diagnosis of COVID-19） | – | Drug: PaxlovidAccording to the patient's medical records, the time from the diagnosis of COVID-19 to the prescription of PAXLOVID exceeds 5 days. |
| No paxlovid used | – | Drug: No paxlovidPatients have never used Paxlovid after being diagnosed with COVID-19, whether before or after hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will focus on COVID-19 infected patients who are admitted to the Beijing Chaoyang Hospital, affiliated with Capital Medical University, from November 15th, 2022 to March 30th, 2023.
Key inclusion criteria (2 listed)
- Confirmed diagnosis of COVID-19 infection.
- Presence of at least one high-risk factor, including age ≥60 years, diabetes, hypertension, cardiovascular disease, stroke, chronic liver or kidney disease, cancer, history of smoking or obesity.
Key exclusion criteria (1 listed)
- No specific exclusion criteria in this 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 |
|---|---|---|
| paxlovidAlso: paxlovid within initial 5 daysPatients treated with PAXLOVID within 5 days of being diagnosed with covid-19 will be included in this group. Patients treated with PAXLOVID will be included in this group. This study is a non-interventional observational study, and no intervention measures were applied to the clinical diagnosis and treatment process of hospitalized COVID-19 patients. The use of Paxlovid is completely decided by the clinical doctors based on the patients' condition and clinical experience. | Drug | Paxlovid（Within 5 days after the diagnosis of COVID-19） |
| No paxlovidPatients not treated with PAXLOVID will be included in this group. This study is a non-interventional observational study, and no intervention measures were applied to the clinical diagnosis and treatment process of hospitalized COVID-19 patients. The use of Paxlovid is completely decided by the clinical doctors based on the patients' condition and clinical experience. | Drug | No paxlovid used |
| PaxlovidAlso: Paxlovid outside of the initial 5 daysPatients treated with PAXLOVID outside of the initial 5 days after being diagnosed with covid-19 will be included in this group. | Drug | Paxlovid （More than 5 days after the diagnosis of COVID-19） |
Primary outcome
Disease progression rates
Time frame: up to 28 days
The proportion of patients who experienced any of the following events within 28 days after being diagnosed with COVID-19, including all-cause mortality, requiring invasive mechanical ventilation, or being admitted to the intensive care unit.
5 secondary outcomes
all-cause deaths rates
Time frame: up to 28 days
rehospitalization event rates
Time frame: up to 28 days
COVID-19 repositive event rates
Time frame: up to 28 days
adverse drug reaction event
Time frame: up to 28 days
thromboembolic event rates
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- 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.
Yi Zhang, PhD principal investigator
Beijing Chao Yang Hospital
Zhuoling An, PhD principal investigator
Beijing Chao Yang Hospital
Chaohui Tong, PhD principal investigator
Beijing Chao Yang Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Beijing Chao Yang Hospital.
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: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yi Zhang, PhD (+86 01085231464, jeffzhang1619@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease progression rates (time frame: up to 28 days). 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 31 Mar 2023.