COVID-19COVHYPNCT04374695
Renin-Angiotensin-Aldosterone System Inhibitors, Hypertension, and COVID-19
An observational study of COVID-19, run by Versailles Hospital.
Trial summary
Background. Angiotensing converting enzyme type 2 (ACE2), a key enzyme of the renin-angiotensin-aldosterone system (RAAS), is the receptor of SARS-CoV-2 for cell entry into lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients presenting to the Centre hospitalier de Versailles emergency department from 2020 March 10th to April, 15th with clinical symptoms suggestive of COVID-19, who fulfilled the inclusion criteria.
Who may be able to join
- Age equal or more than 18;
- Symptoms suggestive of Covid-19 pneumonia. At least : fever > 38°C or influenza-like illness (asthenia, myalgia, chills, muscular aches, …) AND cough or dyspnea;
- Hospitalization required on clinical criteria including: oxygen saturation <96% without oxygen support, respiratory frequency > 25 per minute, hemodynamic instability, medical history or comorbidities known at high risk for Covid-19 (chronic heart disease, congestive heart failure, chronic bronchopulmonary disease, diabetes mellitus, age>70, history of cancer, immunosuppression, …);
- Covid-19 confirmation test performed (RT-PCR).
Who cannot join
- Age < 18
- Refusal to participate in the study
- detainee or prisoner
- Protected adult uncapable to consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Association Between Hypertension, Renin-Angiotensin-Aldosterone System Inhibitors and COVID-19
Background. Angiotensing converting enzyme type 2 (ACE2), a key enzyme of the renin-angiotensin-aldosterone system (RAAS), is the receptor of SARS-CoV-2 for cell entry into lungs. Because ACE2 may be modulated by RAAS inhibitors, such as angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARBs), there is concern that patients treated with ACEi and ARBs may be at higher risk for COVID-19 infection and severity.
Aim. To analyze the associations between COVID-19 and hypertension, and treatments with ACEi and ARBs.
Read more
Methods. In this retrospective observational study, consecutive patients hospitalized for suspected COVID-19 pneumonia will be divided into 2 groups, whether or not COVID-19 is confirmed. The two groups will be compared for baseline characteristics, mainly prior treatment with ACEi and ARBs, and clinical outcome at 1-month follow-up.
The main hypothesis is that ACEi and ARBs, which interact differently with ACE2, may have different relationships with COVID-19 infection or severity.
Read the detailed description
The coronavirus disease 2019 (Covid-19) pandemic is currently the main challenge facing healthcare providers. Data are lacking to guide clinical decision.
The renin-angiotensin-aldosterone system (RAAS) is a key process in cardiology. Its inhibition using angiotensin-converting enzyme inhibitors (ACEi) and angiotensin II type 1-receptor blockers (ARBs) is a cornerstone of the long-term management of arterial hypertension, heart failure and acute coronary syndrome. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uses the angiotensin-converting enzyme 2 (ACE2) as a cellular entry receptor. ACE2 is part of the RAAS and is likely to be modulated by the use of ACEi and ARBs. Therefore, there is concern that patients who are treated with ACEi and ARBs may be at higher risk for Covid-19 infection.
However, little is known regarding how ACEi and ARBs could affect Covid-19 infection and severity. First, ACE2 may have a protective effect against lung injury because it degrades angiotensin II to angiotensin-(1-7). Second, the effect of RAAS inhibition on ACE2 expression has been poorly studied in humans. Third, ACE inhibitors and ARB have different effect on the RAAS and therefore their interaction with Covid-19 may differ.
The COVHYP study is designed to address part of these issues. This is an analytical retrospective observational study that will collect and analyze data regarding patients hospitalized with suspected Covid-19. We planned to screen for inclusion all consecutive patients referred form 10/03/2020 to 15/04/2020 to the emergency department of the Versailles Hospital, a tertiary center located in greater Paris area - one of the region most affected by Covid-19 in France through this period. The inclusion criteria are as follows: 1) Clinical presentation suggestive of COVID-19 pneumonia, at least fever or influenza-like syndrome AND cough or dyspnea; and 2) Test of the presence of SARS-CoV-2 RNA by RT-PCR in nasopharyngeal or sputum samples. Two groups of patients will be defined, those with confirmed Covid-19 pneumonia, and those without Covid-19. Hospital data will gathered, and patients or relatives will be contacted by phone for a one-month follow-up. We will compare baseline characteristics of patients, especially the previous treatment by ACEi or ARBs, in the two groups of patients, and evaluate whether these characteristics can be associated with diagnosis of SARS-CoV-2 infection and severity.
We hope that this study will provide a better understanding of the effect of RAAS inhibitors on Covid-19 pneumonia and its severity.
- Conditions
- COVID-19
- Keywords
- COVID-19, Angiotensin-Converting Enzyme Inhibitors, Angiotensin Receptor Blockers, Renin-Angiotensin System, Hypertension, Observational Study
- 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 |
|---|---|---|
| patients with COVID-19 | Patients with positive RT-PCR for SARS-CoV-2, and patients with négative RT-PCR for SARS-CoV-2 but clinical presentation highly suggestive of COVID-19, and typical COVID-19 abnormalities on chest CT-Scan. | |
| patients without COVID-19 | Patients with négative RT-PCR for SARS-CoV-2 and chest CT-Scan or chest X-ray not suggestive of COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prior treatment by ACEi
Prevalence of a previous treatment by angiotensin converting enzyme inhibitors in patients with and without confirmed Covid-19 pneumonia.
Measured: at admission to hospital
Prior treatment by ARB
Prevalence of a previous treatment by angiotensin II type 1-receptor blockers in patients with and without confirmed Covid-19 pneumonia.
Measured: at admission to hospital
Secondary outcomes (2)
Baseline characteristics and comorbidities
Association between COVID-19 infection status and other baseline characteristics and comorbidities (age, sex, history of hypertension, chronic heart disease, diabetes mellitus, COPD, asthma, obesity, allergies)
Measured: at admission to hospital
Major Clinical Adverse Events
Association between previous treatment by ACEi and ARBs and clinical course of COVID-19 (one-month mortality, hospitalization in intensive care unit, duration of hospital stay, early discharge to home)
Measured: One month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 May 2020 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jul 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.
- 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bernard LIVAREK, MD, Cardiology department, Versailles Hospital, Jean-Paul BERESSI, MD, Department of diabetology, Versailles Hospital, Mehrsa KOUKABI FRADELIZZI, MD, Emergency department, Versailles Hospital, Floriane GILLES, MD, Cardiology department, Versailles Hospital, Alisson BERTRAND, Cardiology department, Versailles Hospital, Marie DE TOURNEMIRE, Cardiology department, Versailles Hospital, Victorien MONGUILLON, Cardiology department, Versailles Hospital, Maeva PASQUALINI, Cardiology department, Versailles Hospital, Alix PREVOT, Cardiology department, Versailles Hospital, Guillaume ROGER, Cardiology department, Versailles Hospital, Joseph SABA, Cardiology department, Versailles Hospital, Joséphine SOLTANI, Cardiology department, Versailles Hospital, Jean-François PROST, Cardiology department, Versailles Hospital, Cécile LAUREANA, Department of medical information, Versailles Hospital
- Responsible party
- Principal investigator, Jean-Louis GEORGES, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374695
- Sponsor's protocol ID
- P20/11_COVHYP
- Acronym
- COVHYP
- Status last verified
- May 2020
- First submitted
- 3 May 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Hypertension, Renin-Angiotensin-Aldosterone System Inhibitors and COVID-19
- ClinicalTrials.gov ID
- NCT04374695
- Acronym / sponsor ID
- COVHYP / P20/11_COVHYP
- Conditions
- COVID-19
- Keywords
- COVID-19, Angiotensin-Converting Enzyme Inhibitors, Angiotensin Receptor Blockers, Renin-Angiotensin System, Hypertension, Observational Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Collaborators
- Bernard LIVAREK, MD, Cardiology department, Versailles Hospital, Jean-Paul BERESSI, MD, Department of diabetology, Versailles Hospital, Mehrsa KOUKABI FRADELIZZI, MD, Emergency department, Versailles Hospital, Floriane GILLES, MD, Cardiology department, Versailles Hospital, Alisson BERTRAND, Cardiology department, Versailles Hospital, Marie DE TOURNEMIRE, Cardiology department, Versailles Hospital, Victorien MONGUILLON, Cardiology department, Versailles Hospital, Maeva PASQUALINI, Cardiology department, Versailles Hospital, Alix PREVOT, Cardiology department, Versailles Hospital, Guillaume ROGER, Cardiology department, Versailles Hospital, Joseph SABA, Cardiology department, Versailles Hospital, Joséphine SOLTANI, Cardiology department, Versailles Hospital, Jean-François PROST, Cardiology department, Versailles Hospital, Cécile LAUREANA, Department of medical information, Versailles Hospital
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 5 May 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.
Background. Angiotensing converting enzyme type 2 (ACE2), a key enzyme of the renin-angiotensin-aldosterone system (RAAS), is the receptor of SARS-CoV-2 for cell entry into lungs. Because ACE2 may be modulated by RAAS inhibitors, such as angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARBs), there is concern that patients treated with ACEi and ARBs may be at higher risk for COVID-19 infection and severity.
Aim. To analyze the associations between COVID-19 and hypertension, and treatments with ACEi and ARBs.
Methods. In this retrospective observational study, consecutive patients hospitalized for suspected COVID-19 pneumonia will be divided into 2 groups, whether or not COVID-19 is confirmed. The two groups will be compared for baseline characteristics, mainly prior treatment with ACEi and ARBs, and clinical outcome at 1-month follow-up.
The main hypothesis is that ACEi and ARBs, which interact differently with ACE2, may have different relationships with COVID-19 infection or severity.
Detailed description
The coronavirus disease 2019 (Covid-19) pandemic is currently the main challenge facing healthcare providers. Data are lacking to guide clinical decision.
The renin-angiotensin-aldosterone system (RAAS) is a key process in cardiology. Its inhibition using angiotensin-converting enzyme inhibitors (ACEi) and angiotensin II type 1-receptor blockers (ARBs) is a cornerstone of the long-term management of arterial hypertension, heart failure and acute coronary syndrome. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uses the angiotensin-converting enzyme 2 (ACE2) as a cellular entry receptor. ACE2 is part of the RAAS and is likely to be modulated by the use of ACEi and ARBs. Therefore, there is concern that patients who are treated with ACEi and ARBs may be at higher risk for Covid-19 infection.
However, little is known regarding how ACEi and ARBs could affect Covid-19 infection and severity. First, ACE2 may have a protective effect against lung injury because it degrades angiotensin II to angiotensin-(1-7). Second, the effect of RAAS inhibition on ACE2 expression has been poorly studied in humans. Third, ACE inhibitors and ARB have different effect on the RAAS and therefore their interaction with Covid-19 may differ.
The COVHYP study is designed to address part of these issues. This is an analytical retrospective observational study that will collect and analyze data regarding patients hospitalized with suspected Covid-19. We planned to screen for inclusion all consecutive patients referred form 10/03/2020 to 15/04/2020 to the emergency department of the Versailles Hospital, a tertiary center located in greater Paris area - one of the region most affected by Covid-19 in France through this period. The inclusion criteria are as follows: 1) Clinical presentation suggestive of COVID-19 pneumonia, at least fever or influenza-like syndrome AND cough or dyspnea; and 2) Test of the presence of SARS-CoV-2 RNA by RT-PCR in nasopharyngeal or sputum samples. Two groups of patients will be defined, those with confirmed Covid-19 pneumonia, and those without Covid-19. Hospital data will gathered, and patients or relatives will be contacted by phone for a one-month follow-up. We will compare baseline characteristics of patients, especially the previous treatment by ACEi or ARBs, in the two groups of patients, and evaluate whether these characteristics can be associated with diagnosis of SARS-CoV-2 infection and severity.
We hope that this study will provide a better understanding of the effect of RAAS inhibitors on Covid-19 pneumonia and its severity.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with COVID-19 | – | –Patients with positive RT-PCR for SARS-CoV-2, and patients with négative RT-PCR for SARS-CoV-2 but clinical presentation highly suggestive of COVID-19, and typical COVID-19 abnormalities on chest CT-Scan. |
| patients without COVID-19 | – | –Patients with négative RT-PCR for SARS-CoV-2 and chest CT-Scan or chest X-ray not suggestive of COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients presenting to the Centre hospitalier de Versailles emergency department from 2020 March 10th to April, 15th with clinical symptoms suggestive of COVID-19, who fulfilled the inclusion criteria.
Key inclusion criteria (4 listed)
- Age equal or more than 18;
- Symptoms suggestive of Covid-19 pneumonia. At least : fever > 38°C or influenza-like illness (asthenia, myalgia, chills, muscular aches, …) AND cough or dyspnea;
- Hospitalization required on clinical criteria including: oxygen saturation <96% without oxygen support, respiratory frequency > 25 per minute, hemodynamic instability, medical history or comorbidities known at high risk for Covid-19 (chronic heart disease, congestive heart failure, chronic bronchopulmonary disease, diabetes mellitus, age>70, history of cancer, immunosuppression, …);
- Covid-19 confirmation test performed (RT-PCR).
Key exclusion criteria (4 listed)
- Age < 18
- Refusal to participate in the study
- detainee or prisoner
- Protected adult uncapable to consent
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
Prior treatment by ACEi
Time frame: at admission to hospital
Prevalence of a previous treatment by angiotensin converting enzyme inhibitors in patients with and without confirmed Covid-19 pneumonia.
Prior treatment by ARB
Time frame: at admission to hospital
Prevalence of a previous treatment by angiotensin II type 1-receptor blockers in patients with and without confirmed Covid-19 pneumonia.
2 secondary outcomes
Baseline characteristics and comorbidities
Time frame: at admission to hospital
Major Clinical Adverse Events
Time frame: One month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Versailles Hospital.
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 4 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 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Jean-Louis GEORGES, MD, MPH (33+139638870, jgeorges@ch-versailles.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prior treatment by ACEi (time frame: at admission to hospital). The study lists 2 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 5 May 2020.