COVID-19NCT05375786
Epidemiological Study on Asymptomatic Infections and Mild Illness With Covid-19 in Shanghai
An observational study of COVID-19, run by Ruijin Hospital at 1 site in China.
Trial summary
this study is to clarify the epidemiological characteristics of Omicron variant infected persons in Shanghai, such as distribution characteristics, host and clinical characteristics, disease outcome and risk factors. especially asymptomatic infections. Read more about this study
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Asymptomatic infections or mild Illness with covid-19 in fangcang shelter hospitals in Shanghai
Who may be able to join
- SARS-Cov-2 RNA positive.
- asymptomatic or mild clinical manifestation.
- informed consent signed.
Who cannot join
- informed consent rejected.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin hospital
Shanghai, Shanghai Municipality, 200025
Ying CHEN, Ph D, +8613917403314, cy11530@rjh.com.cn
Erzhen CHEN, Ph D
About this study
this study is to clarify the epidemiological characteristics of Omicron variant infected persons in Shanghai, such as distribution characteristics, host and clinical characteristics, disease outcome and risk factors. especially asymptomatic infections.
- Conditions
- COVID-19
- Being tested
- Vaccination completion status
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination completion statusBiological
the relation between vaccination completion status and the target population
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 infections | * SARS-Cov-2 RNA positive
* without symptom or with mild clinical manifestations Receives: Biological: Vaccination completion status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral clearance time
time from viral RNA positive to negative
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start2 Apr 2022
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erzhen CHEN, Ph D, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375786
- Sponsor's protocol ID
- SCAM2022
- Status last verified
- Apr 2022
- First submitted
- 13 May 2022
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are not publicly available due to the privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study on Asymptomatic Infections and Mild Illness With Covid-19 in Shanghai
- ClinicalTrials.gov ID
- NCT05375786
- Acronym / sponsor ID
- SCAM2022
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 17 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.
this study is to clarify the epidemiological characteristics of Omicron variant infected persons in Shanghai, such as distribution characteristics, host and clinical characteristics, disease outcome and risk factors. especially asymptomatic infections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 infections | – | Biological: Vaccination completion status* SARS-Cov-2 RNA positive * without symptom or with mild clinical manifestations |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asymptomatic infections or mild Illness with covid-19 in fangcang shelter hospitals in Shanghai
Key inclusion criteria (3 listed)
- SARS-Cov-2 RNA positive.
- asymptomatic or mild clinical manifestation.
- informed consent signed.
Key exclusion criteria (1 listed)
- informed consent rejected.
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 |
|---|---|---|
| Vaccination completion statusthe relation between vaccination completion status and the target population | Biological | COVID-19 infections |
Primary outcome
Viral clearance time
Time frame: 2 months
time from viral RNA positive to negative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No. The data are not publicly available due to the privacy and ethical restrictions.
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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.
Erzhen CHEN, Ph D principal investigator
Ruijin Hospital
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 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 3 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 17 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying CHEN, Ph D (+8613917403314, cy11530@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral clearance time (time frame: 2 months). 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 17 May 2022.