COVID-19 PatientsNCT06349720
Investigating Long-term Health Effects and Complications in COVID-19 Recoveries
An observational study of COVID-19 Patients, run by Zhaohui Tong at 1 site in China.
Trial summary
Clarify the incidence of functional impairments in cured COVID-19 patients and identify influencing factors. Build a multi-omics database for COVID-19 patients in the recovery period to elucidate the biological biomarkers and targets associated with functional impairments. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Patients
- What is being tested?
- respiratory rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17,000 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2023to 7 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 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospital
Who may be able to join
- Meets the diagnostic criteria for confirmed cases according to the "Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 10)";
- The participant or the authorized representative understands the entire purpose of the study, voluntarily participates in the research, and signs an informed consent form, ensuring that they can complete regular assessments at the relevant participating units and receive necessary rehabilitation treatment as required;
- Agrees to the researcher's collection of their peripheral blood samples, saliva samples, and urine samples for the needs of the study.
Who cannot join
- Women who are pregnant or breastfeeding;
- Individuals with mental disorders that affect normal communication;
- Those who refuse to participate in regular assessments and rehabilitation treatments;
- Individuals who decline to provide specimens required for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Institute of Respiratory Medicine
Beijing, Beijing Municipality, 100027
Zhaohui Tong, Dr, +86 010 8523 1000, 13910930309@163.com
About this study
Official title: A Study of the Trajectory of Overall Systemic Health Outcomes and Potential Complications in Recovered COVID-19 Patients.
Clarify the incidence of functional impairments in cured COVID-19 patients and identify influencing factors. Build a multi-omics database for COVID-19 patients in the recovery period to elucidate the biological biomarkers and targets associated with functional impairments. Comprehensive exploration of the long-term prognosis, complications, sequelae, and risk factors of COVID-19 patients after Omicron infection, as well as their immune characteristics. Compare the impact of different strains of the COVID-19 virus on prognosis and immune response. Develop comprehensive rehabilitation intervention strategies for COVID-19 patients with functional impairments and evaluate the impact of different intervention methods on their prognosis. Based on clinical data, multi-omics data, and precise rehabilitation assessment data, construct predictive models for prognosis and rehabilitation effectiveness in COVID-19, providing scientific evidence for the implementation of effective COVID-19 rehabilitation measures.
- Conditions
- COVID-19 Patients
- Being tested
- respiratory rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory rehabilitationBehavioural
Emote respiratory rehabilitation:Patients wear monitoring devices and upload real-time monitoring data such as vital signs through the FREE rehabilitation app installed on their personal phones. Medical staff monitor changes in patients' vital signs in real time through the FREE rehabilitation app on the medical end, and adjust respiratory rehabilitation plans based on their phone or video guidance.
Outpatient respiratory rehabilitation:Traditional outpatient respiratory rehabilitation is based on a group approach, with individualized intensity determined based on baseline assessment results, and is conducted under supervision twice a week for a period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| severe vs non-severe | Not described | |
| COVID-19 patients vs healthy volunteers | Not described | |
| emote respiratory rehabilitation vs outpatient respiratory rehabilitation | Not described Receives: Behavioral: respiratory rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological characteristics associated with functional impairments in COVID-19 convalescent patients
Measured: 6 months, 12 months and 24 months
Changes in laboratory examination indicators
Measured: 6 months, 12 months and 24 months
High-resolution CT of the chest
Measured: 6 months, 12 months and 24 months
Pulmonary function test
Measured: 3 months, 12 months
Multi-omics changes and characteristics associated with functional impairments in COVID-19 convalescent patients
Measured: 6 months, 12 months and 24 months
Inflammatory factors related to body dysfunction in COVID-19 rehabilitation patients
Measured: 6 months, 12 months and 24 months
Regular rehabilitation assessment following respiratory rehabilitation intervention in COVID-19 patients
Measured: 6 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start7 Jun 2023
- Primary completion7 Jun 2024 (estimated)
- Study completion7 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-19 PatientsStudies 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
- 17,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhaohui Tong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhaohui Tong, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349720
- Sponsor's protocol ID
- KF-2023-355
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Trajectory of Overall Systemic Health Outcomes and Potential Complications in Recovered COVID-19 Patients.
- ClinicalTrials.gov ID
- NCT06349720
- Acronym / sponsor ID
- KF-2023-355
- Conditions
- COVID-19 Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17,000 participants (estimated)
- Lead sponsor
- Zhaohui TongUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 7 Jun 2024 (estimated)
- Study completion
- 7 Jun 2024 (estimated)
- First posted
- 5 Apr 2024 (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.
Clarify the incidence of functional impairments in cured COVID-19 patients and identify influencing factors. Build a multi-omics database for COVID-19 patients in the recovery period to elucidate the biological biomarkers and targets associated with functional impairments. Comprehensive exploration of the long-term prognosis, complications, sequelae, and risk factors of COVID-19 patients after Omicron infection, as well as their immune characteristics. Compare the impact of different strains of the COVID-19 virus on prognosis and immune response. Develop comprehensive rehabilitation intervention strategies for COVID-19 patients with functional impairments and evaluate the impact of different intervention methods on their prognosis. Based on clinical data, multi-omics data, and precise rehabilitation assessment data, construct predictive models for prognosis and rehabilitation effectiveness in COVID-19, providing scientific evidence for the implementation of effective COVID-19 rehabilitation measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| severe vs non-severe | – | – |
| COVID-19 patients vs healthy volunteers | – | – |
| emote respiratory rehabilitation vs outpatient respiratory rehabilitation | – | Behavioral: respiratory rehabilitation |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital
Key inclusion criteria (3 listed)
- Meets the diagnostic criteria for confirmed cases according to the "Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 10)";
- The participant or the authorized representative understands the entire purpose of the study, voluntarily participates in the research, and signs an informed consent form, ensuring that they can complete regular assessments at the relevant participating units and receive necessary rehabilitation treatment as required;
- Agrees to the researcher's collection of their peripheral blood samples, saliva samples, and urine samples for the needs of the study.
Key exclusion criteria (4 listed)
- Women who are pregnant or breastfeeding;
- Individuals with mental disorders that affect normal communication;
- Those who refuse to participate in regular assessments and rehabilitation treatments;
- Individuals who decline to provide specimens required for the 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 |
|---|---|---|
| respiratory rehabilitationEmote respiratory rehabilitation:Patients wear monitoring devices and upload real-time monitoring data such as vital signs through the FREE rehabilitation app installed on their personal phones. Medical staff monitor changes in patients' vital signs in real time through the FREE rehabilitation app on the medical end, and adjust respiratory rehabilitation plans based on their phone or video guidance. Outpatient respiratory rehabilitation:Traditional outpatient respiratory rehabilitation is based on a group approach, with individualized intensity determined based on baseline assessment results, and is conducted under supervision twice a week for a period of 12 weeks. | Behavioural | emote respiratory rehabilitation vs outpatient respiratory rehabilitation |
Primary outcome
Immunological characteristics associated with functional impairments in COVID-19 convalescent patients
Time frame: 6 months, 12 months and 24 months
Changes in laboratory examination indicators
Time frame: 6 months, 12 months and 24 months
High-resolution CT of the chest
Time frame: 6 months, 12 months and 24 months
Pulmonary function test
Time frame: 3 months, 12 months
Multi-omics changes and characteristics associated with functional impairments in COVID-19 convalescent patients
Time frame: 6 months, 12 months and 24 months
Inflammatory factors related to body dysfunction in COVID-19 rehabilitation patients
Time frame: 6 months, 12 months and 24 months
Regular rehabilitation assessment following respiratory rehabilitation intervention in COVID-19 patients
Time frame: 6 months, 12 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: Yes
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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.
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 Patients, run by Zhaohui Tong 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 3 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 5 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Tong, Doctor (+86 139 1093 0309, 13910930309@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological characteristics associated with functional impairments in COVID-19 convalescent patients (time frame: 6 months, 12 months and 24 months). The study lists 7 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 5 Apr 2024.