COVID-19NCT04311398
Development and Verification of a New Coronavirus Multiplex Nucleic Acid Detection System
An observational study of COVID-19, run by Huashan Hospital at 1 site in China.
Trial summary
Our project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- COVID-19
- What is being tested?
- New QIAstat-Dx fully automatic multiple PCR detection platform
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2020to 1 Dec 2020
- 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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We'd like to enroll the patients who went to the fever clinic with respiratory infectious symptoms in Huashan Hospital
Who may be able to join
- Patients went to the fever clinic with respiratory infectious symptoms
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040
Wenhong Zhang, PhD,MD, +86 21 52889999 ext. 8123, zhangwenhong@fudan.edu.cn
Jiazhen Chen
About this study
Our project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. The reasonably designed experiments are used to verify the performance of the cartridge detection and prove its clinical application value. The 22 pathogens tested in this project includes 4 coronavirus subtypes, A / B flu, parainfluenza virus, respiratory syncytial virus, etc., which is of great significance for the differential diagnosis of similar patients.
Read the detailed description
COVID-19 has not been well suppressed, and became a pandemic within 3 months globally is mainly because of the virus characteristic in the following aspects:
- Long incubation period (average 5-7 days, up to 28 days), and the incubation period is contagious
- Strong transmissibility, virus can be transmitted through aerosol
- Difficulty distinguishing infected patients from other pathogenic infections
- High negative rate of nucleic acid detection in upper respiratory tract samples of infected patients, which increases the difficulty of differential diagnosis of infection with other pathogens The existing RT-PCR nucleic acid detection kits for SARS-CoV-2 has two major problems. First, the procedure is not automated leading to higher requirements for personnel operation level and environment sterilize. What's more the kits are SARS-CoV-2 only. Once the test result is negative, it cannot help diagnose the exact pathogen in one time of experiment.
Therefore, this project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. The reasonably designed experiments are used to verify the performance of the cartridge detection and prove its clinical application value. The 22 pathogens tested in this project includes 4 coronavirus subtypes, A / B flu, parainfluenza virus, respiratory syncytial virus, etc., which is of great significance for the differential diagnosis of similar patients.
- Conditions
- COVID-19
- Being tested
- New QIAstat-Dx fully automatic multiple PCR detection platform
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New QIAstat-Dx fully automatic multiple PCR detection platformDiagnostic test
We use the New QIAstat-Dx fully automatic multiple PCR detection platform to test the enrolled patients
| Study group | Role | What they receive |
|---|---|---|
| Respiratory infection group | Patients went to fever clinic with respiratory infectious symptoms in Huashan Hospital affiliated to Fudan University Receives: Diagnostic Test: New QIAstat-Dx fully automatic multiple PCR detection platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity， spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start13 May 2020 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Dec 2020 (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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311398
- Sponsor's protocol ID
- KY2020-COVID-19
- Status last verified
- May 2020
- First submitted
- 14 Mar 2020
- Last updated
- 14 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Verification of a New Coronavirus Multiplex Nucleic Acid Detection System
- ClinicalTrials.gov ID
- NCT04311398
- Acronym / sponsor ID
- KY2020-COVID-19
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 13 May 2020 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 17 Mar 2020 (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.
Our project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. The reasonably designed experiments are used to verify the performance of the cartridge detection and prove its clinical application value. The 22 pathogens tested in this project includes 4 coronavirus subtypes, A / B flu, parainfluenza virus, respiratory syncytial virus, etc., which is of great significance for the differential diagnosis of similar patients.
Detailed description
COVID-19 has not been well suppressed, and became a pandemic within 3 months globally is mainly because of the virus characteristic in the following aspects:
- Long incubation period (average 5-7 days, up to 28 days), and the incubation period is contagious
- Strong transmissibility, virus can be transmitted through aerosol
- Difficulty distinguishing infected patients from other pathogenic infections
- High negative rate of nucleic acid detection in upper respiratory tract samples of infected patients, which increases the difficulty of differential diagnosis of infection with other pathogens The existing RT-PCR nucleic acid detection kits for SARS-CoV-2 has two major problems. First, the procedure is not automated leading to higher requirements for personnel operation level and environment sterilize. What's more the kits are SARS-CoV-2 only. Once the test result is negative, it cannot help diagnose the exact pathogen in one time of experiment.
Therefore, this project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. The reasonably designed experiments are used to verify the performance of the cartridge detection and prove its clinical application value. The 22 pathogens tested in this project includes 4 coronavirus subtypes, A / B flu, parainfluenza virus, respiratory syncytial virus, etc., which is of great significance for the differential diagnosis of similar patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory infection group | – | Diagnostic Test: New QIAstat-Dx fully automatic multiple PCR detection platformPatients went to fever clinic with respiratory infectious symptoms in Huashan Hospital affiliated to Fudan University |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We'd like to enroll the patients who went to the fever clinic with respiratory infectious symptoms in Huashan Hospital
Key inclusion criteria (1 listed)
- Patients went to the fever clinic with respiratory infectious symptoms
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| New QIAstat-Dx fully automatic multiple PCR detection platformWe use the New QIAstat-Dx fully automatic multiple PCR detection platform to test the enrolled patients | Diagnostic test | Respiratory infection group |
Primary outcome
Sensitivity， spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- 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.
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 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 May 2020. 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 Wenhong Zhang, Doctor (13801844344, zhangwenhong@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity， spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform (time frame: 3 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 14 May 2020.