COVID-19HT-COVID19NCT04318301
Hypertension in Patients Hospitalized With COVID-19
An observational study of COVID-19 and Hypertension, run by Zhenhua Zen at 1 site in China.
Trial summary
Some studies have shown that the main pathogenesis of patients with covid19 is related to ACE2 receptor. Lung is one of the main organs, and there are many ACE2 receptors in cardiovascular system. ACEI / ARB is the main target of antihypertensive drugs. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19, Hypertension
- How many people
- 275 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2020to 30 Mar 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: Patients with clinically confirmed COVID-19 admitted to Hankou Hospital, Wuhan, China from January 5 to March 8, 2020.
Who may be able to join
- COVID-19 pneumonia patients diagnosed by WHO criteria
Who cannot join
- Patients who were younger than 18 years.
- Patients whose entire stay lasted for less than 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypertension in Patients Hospitalized With COVID-19 in Wuhan, China: A Single-center Retrospective Observational Study
Some studies have shown that the main pathogenesis of patients with covid19 is related to ACE2 receptor. Lung is one of the main organs, and there are many ACE2 receptors in cardiovascular system. ACEI / ARB is the main target of antihypertensive drugs. Previous reports suggested that there were large number of patients with covid19 also suffered from hypertension, suggesting that patients with hypertension may be the susceptible to covid19. Therefore, we try to follow up the patients admitted to Hankou hospital to explore the impact of hypertension and hypertension treatment on the severity and prognosis of patients with covid19, so as to provide new methods for the treatment of patients with covid19 in the future.
Read the detailed description
In December, 2019, a cluster of severe pneumonia cases of unknown cause emerged in Wuhan, China, with clinical presentations greatly resembling viral pneumonia1. Deep sequencing analysis from lower respiratory tract samples indicated a novel coronavirus, which was named 2019 novel coronavirus (2019-nCoV, then named COVID-19). Up to Mar 16, 2020, the total number of patients had risen sharply to 153,546 confirmed cases worldwide (http://2019ncov.chinacdc.cn/2019-nCoV/global.html). The data extracted from 1099 patients with laboratory-confirmed COVID-19 in China from January 29, 2020 showed that hypertension is the most common coexisting illness of COVID-19 patients, ranging from 13.4% in nonsevere patient vs. 23.4% in severe patients, and the total incidence is as high as 15%2. Interestingly, ACE2 is involved in the pathogenesis of both hypertension and SARS-COV-2 pneumonia. The above reasons prompted us to speculate that the organs attacked by SARS-COV-2 might not only be lungs, but also include other ACE2 expression organs, especially cardiovascular system. In addition, patients with comorbid hypertension, especially those with long-term oral ACEI/ARB medication for hypertension, might have different susceptibility and severity levels of pneumonia upon SARS-COV-2 attack. Therefore, we investigated and compared the demographic characteristics, coexisting disease, severity of pneumonia, and the effect of antihypertensive drugs (ACEI/ARB versus non-ACEI/ARB) in patients with COVID-19 coexisting hypertension, thereby, hopefully, to reduce the mortality and morbidity associated with hypertension in patients with COVID-19.
- Conditions
- COVID-19, Hypertension
- Keywords
- COVID-19, Hypertension, ACE2
- Medical subject headings
- COVID-19, Hypertension
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/ARB | COVID-19 patients with hypertension who had previously taken ACEI/ARB for antihypertensive treatment | |
| non ACEI/ARB | COVID-19 patients with hypertension who had not previously taken ACEI/ARB for antihypertensive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Death
mortality in 28-day
Measured: From date of admission until the date of death from any cause, up to 60 days
Secondary outcomes (1)
the severity of pneumonia
evaluate the severity of pneumonia according to CT scans and clinical manifestation
Measured: From date of admission until the date of discharge or death from any cause, up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start21 Mar 2020
- Primary completion28 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhenhua Zen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhenhua Zen, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318301
- Sponsor's protocol ID
- HT-COVID19
- Acronym
- HT-COVID19
- Status last verified
- Apr 2020
- First submitted
- 20 Mar 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
PubMed 31978945Li W, Moore MJ, Vasilieva N, Sui J, Wong SK, Berne MA, Somasundaran M, Sullivan JL, Luzuriaga K, Greenough TC, Choe H, Farzan M. Angiotensin-converting enzyme 2 is a functional receptor for the SARS coronavirus. Nature. 2003 Nov 27;426(6965):450-4. doi: 10.1038/nature02145.
PubMed 14647384Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Wang Z, Chen Z, Zhang L, Wang X, Hao G, Zhang Z, Shao L, Tian Y, Dong Y, Zheng C, Wang J, Zhu M, Weintraub WS, Gao R; China Hypertension Survey Investigators. Status of Hypertension in China: Results From the China Hypertension Survey, 2012-2015. Circulation. 2018 May 29;137(22):2344-2356. doi: 10.1161/CIRCULATIONAHA.117.032380. Epub 2018 Feb 15.
PubMed 29449338Ferrario CM, Jessup J, Chappell MC, Averill DB, Brosnihan KB, Tallant EA, Diz DI, Gallagher PE. Effect of angiotensin-converting enzyme inhibition and angiotensin II receptor blockers on cardiac angiotensin-converting enzyme 2. Circulation. 2005 May 24;111(20):2605-10. doi: 10.1161/CIRCULATIONAHA.104.510461. Epub 2005 May 16.
PubMed 15897343Turner AJ, Hiscox JA, Hooper NM. ACE2: from vasopeptidase to SARS virus receptor. Trends Pharmacol Sci. 2004 Jun;25(6):291-4. doi: 10.1016/j.tips.2004.04.001.
PubMed 15165741
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension in Patients Hospitalized With COVID-19 in Wuhan, China: A Single-center Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT04318301
- Acronym / sponsor ID
- HT-COVID19 / HT-COVID19
- Conditions
- COVID-19, Hypertension
- Keywords
- COVID-19, Hypertension, ACE2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Zhenhua ZenUniversity, hospital or other
- Study start
- 21 Mar 2020 (actual)
- Primary completion
- 28 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 23 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.
Some studies have shown that the main pathogenesis of patients with covid19 is related to ACE2 receptor. Lung is one of the main organs, and there are many ACE2 receptors in cardiovascular system. ACEI / ARB is the main target of antihypertensive drugs. Previous reports suggested that there were large number of patients with covid19 also suffered from hypertension, suggesting that patients with hypertension may be the susceptible to covid19. Therefore, we try to follow up the patients admitted to Hankou hospital to explore the impact of hypertension and hypertension treatment on the severity and prognosis of patients with covid19, so as to provide new methods for the treatment of patients with covid19 in the future.
Detailed description
In December, 2019, a cluster of severe pneumonia cases of unknown cause emerged in Wuhan, China, with clinical presentations greatly resembling viral pneumonia1. Deep sequencing analysis from lower respiratory tract samples indicated a novel coronavirus, which was named 2019 novel coronavirus (2019-nCoV, then named COVID-19). Up to Mar 16, 2020, the total number of patients had risen sharply to 153,546 confirmed cases worldwide (http://2019ncov.chinacdc.cn/2019-nCoV/global.html). The data extracted from 1099 patients with laboratory-confirmed COVID-19 in China from January 29, 2020 showed that hypertension is the most common coexisting illness of COVID-19 patients, ranging from 13.4% in nonsevere patient vs. 23.4% in severe patients, and the total incidence is as high as 15%2. Interestingly, ACE2 is involved in the pathogenesis of both hypertension and SARS-COV-2 pneumonia. The above reasons prompted us to speculate that the organs attacked by SARS-COV-2 might not only be lungs, but also include other ACE2 expression organs, especially cardiovascular system. In addition, patients with comorbid hypertension, especially those with long-term oral ACEI/ARB medication for hypertension, might have different susceptibility and severity levels of pneumonia upon SARS-COV-2 attack. Therefore, we investigated and compared the demographic characteristics, coexisting disease, severity of pneumonia, and the effect of antihypertensive drugs (ACEI/ARB versus non-ACEI/ARB) in patients with COVID-19 coexisting hypertension, thereby, hopefully, to reduce the mortality and morbidity associated with hypertension in patients with COVID-19.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACEI/ARB | – | –COVID-19 patients with hypertension who had previously taken ACEI/ARB for antihypertensive treatment |
| non ACEI/ARB | – | –COVID-19 patients with hypertension who had not previously taken ACEI/ARB for antihypertensive treatment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically confirmed COVID-19 admitted to Hankou Hospital, Wuhan, China from January 5 to March 8, 2020.
Key inclusion criteria (1 listed)
- COVID-19 pneumonia patients diagnosed by WHO criteria
Key exclusion criteria (2 listed)
- Patients who were younger than 18 years.
- Patients whose entire stay lasted for less than 48 hours.
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
Rate of Death
Time frame: From date of admission until the date of death from any cause, up to 60 days
mortality in 28-day
1 secondary outcome
the severity of pneumonia
Time frame: From date of admission until the date of discharge or death from any cause, up to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Background: PubMed 31978945Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
- Background: PubMed 14647384Li W, Moore MJ, Vasilieva N, Sui J, Wong SK, Berne MA, Somasundaran M, Sullivan JL, Luzuriaga K, Greenough TC, Choe H, Farzan M. Angiotensin-converting enzyme 2 is a functional receptor for the SARS coronavirus. Nature. 2003 Nov 27;426(6965):450-4. doi: 10.1038/nature02145.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 29449338Wang Z, Chen Z, Zhang L, Wang X, Hao G, Zhang Z, Shao L, Tian Y, Dong Y, Zheng C, Wang J, Zhu M, Weintraub WS, Gao R; China Hypertension Survey Investigators. Status of Hypertension in China: Results From the China Hypertension Survey, 2012-2015. Circulation. 2018 May 29;137(22):2344-2356. doi: 10.1161/CIRCULATIONAHA.117.032380. Epub 2018 Feb 15.
- Background: PubMed 15897343Ferrario CM, Jessup J, Chappell MC, Averill DB, Brosnihan KB, Tallant EA, Diz DI, Gallagher PE. Effect of angiotensin-converting enzyme inhibition and angiotensin II receptor blockers on cardiac angiotensin-converting enzyme 2. Circulation. 2005 May 24;111(20):2605-10. doi: 10.1161/CIRCULATIONAHA.104.510461. Epub 2005 May 16.
- Background: PubMed 15165741Turner AJ, Hiscox JA, Hooper NM. ACE2: from vasopeptidase to SARS virus receptor. Trends Pharmacol Sci. 2004 Jun;25(6):291-4. doi: 10.1016/j.tips.2004.04.001.
- A Novel Coronavirus From Patients With Pneumonia in China, 2019Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 COVID-19 and Hypertension, run by Zhenhua Zen 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 2 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: finished, as of the sponsor's last update on 29 Apr 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Death (time frame: From date of admission until the date of death from any cause, up to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04318301, which also lists 6 linked publications.
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 29 Apr 2020.