Is there a benefit in treating novel corona virus (Sars-CoV2) infections with the established antihypertensive valsartan?

Treatment of Sars-CoV2 infections (Covid-19) in patients without or with chronic kidney disease (CKD) with valsartan vs placebo, a three-armed randomized, partly blinded trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001431-27-DE

Enrollment

300

Registered

2020-04-07

Start date

2020-06-05

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sars-Cov2 infection

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: VALSARTAN CAS Number: 137862-53-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- Pharmaceutical form of the pl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients aged over 18 years with given consent, first positive Sars-Cov2 detection within the last three days - Patients with pre-existing chronic renal insufficiency in any degree of severity - Patients of both gender Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: - intolerance to RAS-I and ARB - Contraindications against ACE/ARB according to current clinical standard - History of falls (more than 2 falls in the last 8 weeks) - Symptomatic hypotension (i.e. blood pressure < 100 mmHg systolic and/or 50 mmHg diastolic together with hypotensive symptoms) - Acute renal failure from stage 2 - pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Since there is currently no high level evidence that allows a clear evaluation of advantages or disadvantages of a RAS-system inhibiting therapy (ACE-I, ARB) the influence of RAS-influencing drugs on COVID-19 will be investigated. The randomized switch from ACE-I to ARB against retention of ACE-I will be compared. The new setting with ARB (valsartan) will be compared against the administration of placebo.;Secondary Objective: By characterizing virus binding epitopes with relevance to a clinically relevant immune response, patient-side protein structures (Ig epitopes) can be identified, which are important for new fast and inexpensive testing possibilities and vaccination development.;Primary end point(s): combined clinical improvement (7-category ordinal scale of clinical Status or Hospital discharge);Timepoint(s) of evaluation of this end point: daily	—

Measure

Time frame

Main Objective: Since there is currently no high level evidence that allows a clear evaluation of advantages or disadvantages of a RAS-system inhibiting therapy (ACE-I, ARB) the influence of RAS-influencing drugs on COVID-19 will be investigated. The randomized switch from ACE-I to ARB against retention of ACE-I will be compared. The new setting with ARB (valsartan) will be compared against the administration of placebo.;Secondary Objective: By characterizing virus binding epitopes with relevance to a clinically relevant immune response, patient-side protein structures (Ig epitopes) can be identified, which are important for new fast and inexpensive testing possibilities and vaccination development.;Primary end point(s): combined clinical improvement (7-category ordinal scale of clinical Status or Hospital discharge);Timepoint(s) of evaluation of this end point: daily

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are collected post-hoc according to the availability of routine data. Mainly respiratory indices (Horovitz), virus load or PCR results, ventilation frequency, duration of hospitalisation and death are considered. ;Timepoint(s) of evaluation of this end point: according to availability	—

Countries

Germany

Contacts

Public ContactGeschäftsführung

Klinikum St. Georg gGmbH

004903419090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026