NCT04374695: COVHYP

Renin-Angiotensin-Aldosterone System Inhibitors, Hypertension, and COVID-19

Status unknown Last updated 5 May 2020

What this trial tests

trial in COVID-19 in 700 participants. Status unknown.

Timeline

1 May 2020

Primary endpoint
1 June 2020

1 July 2020

Quick facts

Lead sponsor	Versailles Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	700
Start date	1 May 2020
Primary completion	1 June 2020
Estimated completion	1 July 2020

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Versailles Hospital

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. ACE2 imbalance as a key player for the poor outcomes in COVID-19 patients with age-related comorbidities - Role of gut microbiota dysbiosis.
   Viana SD, Nunes S, Reis F. · · 2020 · cited 122× · PMID 32683039 · DOI 10.1016/j.arr.2020.101123
2. The Rationale for Potential Pharmacotherapy of COVID-19.
   Saber-Ayad M, Saleh MA, Abu-Gharbieh E. · · 2020 · cited 30× · PMID 32423024 · DOI 10.3390/ph13050096
3. ACE2 as a Therapeutic Target for COVID-19; its Role in Infectious Processes and Regulation by Modulators of the RAAS System.
   Michaud V, Deodhar M, Arwood M, Al Rihani SB, et al · · 2020 · cited 29× · PMID 32635289 · DOI 10.3390/jcm9072096
4. Renin-angiotensin system at the interface of COVID-19 infection.
   Gul R, Kim UH, Alfadda AA. · · 2021 · cited 24× · PMID 33086029 · DOI 10.1016/j.ejphar.2020.173656
5. Angiotensin-converting enzyme 2: a double-edged sword in COVID-19 patients with an increased risk of heart failure.
   Razeghian-Jahromi I, Zibaeenezhad MJ, Lu Z, Zahra E, et al · · 2021 · cited 19× · PMID 32844337 · DOI 10.1007/s10741-020-10016-2
6. Hypertension and COVID-19: Updates from the era of vaccines and variants.
   Swamy S, Koch CA, Hannah-Shmouni F, Schiffrin EL, et al · · 2022 · cited 10× · PMID 34900602 · DOI 10.1016/j.jcte.2021.100285
7. [Association of hypertension and antihypertensive agents and the severity of COVID-19 pneumonia. A monocentric French prospective study].
   Georges JL, Cochet H, Roger G, Ben Jemaa H, et al · · 2020 · cited 10× · PMID 33039120 · DOI 10.1016/j.ancard.2020.09.030
8. Biologia Futura: is ADAM 17 the reason for COVID-19 susceptibility in hyperglycemic and diabetic patients?
   Stepanova G. · · 2021 · cited 7× · PMID 34554559 · DOI 10.1007/s42977-021-00092-2