COVID-19NCT05986435
Long-term Follow-up Study of COVID-19
An observational study of COVID-19, run by Tongji Hospital at 2 sites in China.
Trial summary
The goal of this observational study is to learn the long-term prognosis of patients and the clinical characteristics of complications, which is of great significance for treatment of novel coronavirus infection pneumonia. This trial plans to include 5700 inpatients with positive SARS CoV-2 nucleic acid test results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 5,700 participants
- Where
- 2 sitesChina
- Study dates
- 20 Oct 2020to 31 Dec 2023
- 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: The inpatients with positive SARS CoV-2 nucleic acid test results will be included.
Who may be able to join
- Patients with confirmed COVID-19
Who cannot join
- Combined infection with influenza virus, mycoplasma, and chlamydia.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei
Qin Ning, +8613971521450, qning@vip.sina.com
- Recruiting
Wuhan Seventh Hospital
Wuhan, Hubei
Qin You Yan, 18071702539, 971716425@qq.com
About this study
Official title: Long-term Large Sample Multicenter Follow-up Study of COVID-19
The goal of this observational study is to learn the long-term prognosis of patients and the clinical characteristics of complications, which is of great significance for treatment of novel coronavirus infection pneumonia.
This trial plans to include 5700 inpatients with positive SARS CoV-2 nucleic acid test results. This trial does not involve the use of specific drug. Participants's health and psychological status will be observed at the preset time points. The blood, feces, urine samples of patients will be collected for relevant tests.
Read the detailed description
After the patients are enrolled, record the patient's treatment regimens, blood routine results, blood biochemistry results, cytokines results, lung imaging results, and cranial imaging results, understand the patient's current clinical manifestations, evaluate the patient's psychological status and quality of life, and collect samples of the patients' blood, feces, urine, and other related tests.
Collection of clinical samples: collect blood, urine, throat swabs and other samples from patients with confirmed novel coronavirus pneumonia (Nucleic acid test positive), and collect samples for relevant tests at 3 months, 6 months, 12 months, 18 months, 24 months and 36 months after discharge of patients, and record the clinical manifestations of patients.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical manifestation
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Secondary outcomes (9)
psychological status
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
quality of life scores
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
cranial imaging results
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
lung imaging results
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
cytokines level
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
blood biochemistry results
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
routine blood test results
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
treatment regimens
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
survival rate
Measured: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start20 Oct 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 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 Tongji 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
- Other
- Time perspective
- Other
- Enrolment
- 5,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
- Investigators
- Qin Ning, Professor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986435
- Sponsor's protocol ID
- PROCOVER
- Status last verified
- Jul 2023
- First submitted
- 8 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Large Sample Multicenter Follow-up Study of COVID-19
- ClinicalTrials.gov ID
- NCT05986435
- Acronym / sponsor ID
- PROCOVER
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,700 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Aug 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 goal of this observational study is to learn the long-term prognosis of patients and the clinical characteristics of complications, which is of great significance for treatment of novel coronavirus infection pneumonia.
This trial plans to include 5700 inpatients with positive SARS CoV-2 nucleic acid test results. This trial does not involve the use of specific drug. Participants's health and psychological status will be observed at the preset time points. The blood, feces, urine samples of patients will be collected for relevant tests.
Detailed description
After the patients are enrolled, record the patient's treatment regimens, blood routine results, blood biochemistry results, cytokines results, lung imaging results, and cranial imaging results, understand the patient's current clinical manifestations, evaluate the patient's psychological status and quality of life, and collect samples of the patients' blood, feces, urine, and other related tests.
Collection of clinical samples: collect blood, urine, throat swabs and other samples from patients with confirmed novel coronavirus pneumonia (Nucleic acid test positive), and collect samples for relevant tests at 3 months, 6 months, 12 months, 18 months, 24 months and 36 months after discharge of patients, and record the clinical manifestations of patients.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The inpatients with positive SARS CoV-2 nucleic acid test results will be included.
Key inclusion criteria (1 listed)
- Patients with confirmed COVID-19
Key exclusion criteria (1 listed)
- Combined infection with influenza virus, mycoplasma, and chlamydia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical manifestation
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
9 secondary outcomes
psychological status
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
quality of life scores
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
cranial imaging results
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
lung imaging results
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
cytokines level
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
blood biochemistry results
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
routine blood test results
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
treatment regimens
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
survival rate
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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.
Qin Ning, Professor principal investigator
Tongji Hospital
2 sites 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 Tongji Hospital at 2 sites 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 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Qin Ning, Professor (+8613971521450, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical manifestation (time frame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge). 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 2023.