Clinical trial NCT04606563: Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?
Official title: Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?
Conditions: Covid19
SARS-CoV Infection
Summary: SARS-CoV-2 is a member of a class of viruses: angiotensin converting enzyme 2 (ACE2)-binding viruses that study calls "ABVs". The World Health Organization (WHO) and others are performing randomized controlled trials (RCTs) of vaccines and novel antivirals to address SARS-CoV-2 directly. However, the critical illness complications of COVID-19 are caused in part by SARS-CoV-2's binding and inhibiting ACE2 and the consequent host response.
ACE 2 is the receptor for H1N1, H5N1, and SARS-CoV-2. After binding ACE2, SARS-CoV-2 is endocytosed, and surface ACE2 is down-regulated, increasing angiotensin II (ATII a potent vasoconstrictor) in COVID-19. The original ARBs limits lung injury in murine influenza H7N9 and decreases viral titre and RNA.
Study has a unique opportunity to complement vaccine and anti-viral RCTs with an RCT modulating the host response using an angiotensin II type 1 receptor blocker (ARBs) to decrease the mortality of hospitalized COVID-19 patient.
Interventions:
description: Oral losartan 25 mg, stepped up to 50 mg and then up to 100 mg peak dose, as tolerated.
name: Losartan
other_name: Cozaar
type: Drug
description: Oral Valsartan 40 mg, stepped up to 80 mg and then up to 160 mg peak dose, as tolerated.
name: Valsartan
other_name: Diovan
type: Drug
description: Oral Azilsartan 40 mg, and stepped up to 80 mg.
name: Azilsartan
other_name: Edarbi
type: Drug
description: Oral Candesartan 8 mg, stepped up to 16 mg and then up to 32 mg peak dose, as tolerated.
name: Candesartan
other_name: Atacand
type: Drug
description: Oral Eprosartan 400 mg, stepped up to 600 mg and then up to 800 mg peak dose, as tolerated.
name: Eprosartan
other_name: Teventen
type: Drug
description: Oral Irbesartan 75 mg, stepped up to 150 mg and then up to 300 mg peak dose, as tolerated.
name: Irbesartan
other_name: Avapro
type: Drug
description: Oral Olmesartan 10 mg, stepped up to 20 mg and then up to 40 mg peak dose, as tolerated.
name: Olmesartan
other_name: Olmetec
type: Drug
description: Oral Azilsartan 40 mg, and stepped up to 80 mg.
name: Telmisartan
other_name: Micardis
type: Drug
Study arms:
design_group_description: Patients will initially receive initial dose of oral ARBs, increased to higher dose after 24 hours and then increased to a max dose after another 24 hours, dependent on tolerance. Patient will remain at dose for duration of hospital (max of 3 months if still hospitalized). Tolerance is defined as having no severe adverse events 24 hours after the first dose. Investigators and/or attending physicians discretion may dictate that dose will not be increased, at which point dose will stay at initial or higher dose.
design_group_title: ARBs (Losartan, Valsartan, Azilsartan, Candesartan, Eprosartan, Irbesartan, Olmesartan, Telmisartan)
design_group_type: Experimental
design_group_description: Usual care for duration of hospitalization for up to 3 months if still hospitalized. Due to the lack of clinical guidance from this emergent disease, this may vary dependent on Institution and/or country
design_group_title: Usual Care Control
design_group_type: No Intervention
Sponsor: University of British Columbia
Collaborators: Canadian Institutes of Health Research
Drug name mappings:
name: 厄贝沙坦
lang: CN
name: Irbesartan
lang: EN
name: イルベサルタン
lang: JP
name: 坎地沙坦酯
lang: CN
name: Candesartan Cilexetil
lang: EN
name: カンデサルタン シレキセチル
lang: JP
name: 缬沙坦
lang: CN
name: Valsartan
lang: EN
name: バルサルタン
lang: JP
name: 依普沙坦
lang: CN
name: Eprosartan Mesylate
lang: EN
name: 奥美沙坦酯
lang: CN
name: Olmesartan Medoxomil
lang: EN
name: オルメサルタン メドキソミル
lang: JP
name: 阿齐沙坦酯钾盐
lang: CN
name: Azilsartan Kamedoxomil
lang: EN
name: 氯沙坦钾
lang: CN
name: Losartan Potassium
lang: EN
name: ロサルタンカリウム
lang: JP
name: 替米沙坦
lang: CN
name: Telmisartan
lang: EN
name: テルミサルタン
lang: JP