2019-nCoVNCT04272710
Prognositc Factors in COVID-19 Patients Complicated With Hypertension
An observational study of 2019-nCoV, run by Chongqing Medical University at 1 site in China.
Trial summary
There are currently no clinical studies reporting clinical characteristics difference between the hypertension patients with and without ACEI treatment when suffered with novel coronavirus infection in China. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- 2019-nCoV
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2020to 30 Apr 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the hypertension patients with and without ACEI treatment when suffered with novel coronavirus infection in China
Who may be able to join
- Adult aged >=18years old;
- Diagnosed with 2019-nCoV. Diagnostic criteria including: Laboratory (RT-PCR) confirmed 2019-nCoV infection; CT of the lung conformed to the manifestation of viral pneumonia.
- Diagnosed with primary hypertension.
- Criteria for severe or critical ill conditions: Respiratory rate >=30/min; or Rest SPO2<=93%; or PaO2/FiO2<=300mmHg.
Who cannot join
- Near-death state (expected survival time less than 24 hours);
- Malignant tumor;
- Pregnancy or puerperium women;
- ACEI contraindication
- Patients who refused to participant.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing
About this study
Official title: Prognostic Characteristics Difference Between the Hypertension Patients With and Without ACEI Treatment When Suffered With 2019-nCoV Infection in China
There are currently no clinical studies reporting clinical characteristics difference between the hypertension patients with and without ACEI treatment when suffered with novel coronavirus infection in China.
Read the detailed description
At present, the outbreak of the new coronavirus (2019-nCoV) infection in Wuhan and Hubei provinces has attracted great attention from the medical community across the country. Both 2019-nCoV and SARS viruses are coronaviruses, and they have a large homology.
Published laboratory studies have suggested that SARS virus infection and its lung injury are related to angiotensin-converting enzyme 2 (ACE2) in lung tissue. And ACE and ACE2 in the renin-angiotensin system (RAS) are vital central links to maintain hemodynamic stability and normal heart and kidney function in vivo.
A large amount of evidence-based medical evidence shows that ACE inhibitors are the basic therapeutic drugs for maintaining hypertension, reducing the risk of cardiovascular, cerebrovascular, and renal adverse events, improving quality of life, and prolonging life in patients with hypertension. Recent experimental studies suggest that treatment with ACE inhibitors can significantly reduce pulmonary inflammation and cytokine release caused by coronavirus infection.
- Conditions
- 2019-nCoV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ACEI treatment | hypertension patients with ACEI treatment when suffered with novel coronavirus infection in China | |
| Control | hypertension patients without ACEI treatment when suffered with novel coronavirus infection in China |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupancy rate in the intensive care unit (ICU)
The percentage of patients admitted to the ICU at any time during the 28 days of onset COVID-19.
Measured: up to 28 days
Mechanical Ventilation
The number of patients requiring mechanical ventilation.
Measured: up to 28 days
Death
The number of patients who died of 2019-nCoV infection.
Measured: up to 28 days
Secondary outcomes (3)
All cause mortality
The number of died 2019-nCoV infected patients from any cause.
Measured: up to 28 days
Time from onset of symptoms to main outcome and its components
Time from onset of symptoms to admitted to the ICU, requiring mechanical ventilation, and death.
Measured: up to 28 days
Time to Clinical Recovery
Time to Clinical Recovery
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 posted17 Feb 2020
- Study start25 Jan 2020
- Primary completion31 Mar 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Why it stopped: Similar projects have been registered, and it need to be withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2019-nCoVStudies 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongying Zhang, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272710
- Sponsor's protocol ID
- 2020-02
- Status last verified
- Mar 2020
- First submitted
- 12 Feb 2020
- Last updated
- 17 Mar 2020
- 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 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Characteristics Difference Between the Hypertension Patients With and Without ACEI Treatment When Suffered With 2019-nCoV Infection in China
- ClinicalTrials.gov ID
- NCT04272710
- Acronym / sponsor ID
- 2020-02
- Conditions
- 2019-nCoV
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Similar projects have been registered, and it need to be withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 25 Jan 2020 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 17 Feb 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.
There are currently no clinical studies reporting clinical characteristics difference between the hypertension patients with and without ACEI treatment when suffered with novel coronavirus infection in China.
Detailed description
At present, the outbreak of the new coronavirus (2019-nCoV) infection in Wuhan and Hubei provinces has attracted great attention from the medical community across the country. Both 2019-nCoV and SARS viruses are coronaviruses, and they have a large homology.
Published laboratory studies have suggested that SARS virus infection and its lung injury are related to angiotensin-converting enzyme 2 (ACE2) in lung tissue. And ACE and ACE2 in the renin-angiotensin system (RAS) are vital central links to maintain hemodynamic stability and normal heart and kidney function in vivo.
A large amount of evidence-based medical evidence shows that ACE inhibitors are the basic therapeutic drugs for maintaining hypertension, reducing the risk of cardiovascular, cerebrovascular, and renal adverse events, improving quality of life, and prolonging life in patients with hypertension. Recent experimental studies suggest that treatment with ACE inhibitors can significantly reduce pulmonary inflammation and cytokine release caused by coronavirus infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACEI treatment | – | –hypertension patients with ACEI treatment when suffered with novel coronavirus infection in China |
| Control | – | –hypertension patients without ACEI treatment when suffered with novel coronavirus infection in China |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the hypertension patients with and without ACEI treatment when suffered with novel coronavirus infection in China
Key inclusion criteria (4 listed)
- Adult aged >=18years old;
- Diagnosed with 2019-nCoV. Diagnostic criteria including: Laboratory (RT-PCR) confirmed 2019-nCoV infection; CT of the lung conformed to the manifestation of viral pneumonia.
- Diagnosed with primary hypertension.
- Criteria for severe or critical ill conditions: Respiratory rate >=30/min; or Rest SPO2<=93%; or PaO2/FiO2<=300mmHg.
Key exclusion criteria (5 listed)
- Near-death state (expected survival time less than 24 hours);
- Malignant tumor;
- Pregnancy or puerperium women;
- ACEI contraindication
- Patients who refused to participant.
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
Occupancy rate in the intensive care unit (ICU)
Time frame: up to 28 days
The percentage of patients admitted to the ICU at any time during the 28 days of onset COVID-19.
Mechanical Ventilation
Time frame: up to 28 days
The number of patients requiring mechanical ventilation.
Death
Time frame: up to 28 days
The number of patients who died of 2019-nCoV infection.
3 secondary outcomes
All cause mortality
Time frame: up to 28 days
Time from onset of symptoms to main outcome and its components
Time frame: up to 28 days
Time to Clinical Recovery
Time frame: up to 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 2019-nCoV, run by Chongqing Medical University 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 17 Mar 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occupancy rate in the intensive care unit (ICU) (time frame: up to 28 days). The study lists 3 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 17 Mar 2020.