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PRAETORIAN-COVID: A Double-blind, Placebo-controlled Randomized Clinical Trial With Valsartan for PRevention of Acute rEspiraTORy dIstress Syndrome in hospitAlized patieNts With SARS-COV-2 (COVID-19) Infection Disease

Trial Profile

PRAETORIAN-COVID: A Double-blind, Placebo-controlled Randomized Clinical Trial With Valsartan for PRevention of Acute rEspiraTORy dIstress Syndrome in hospitAlized patieNts With SARS-COV-2 (COVID-19) Infection Disease

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 28 May 2020

At a glance

  • Drugs Valsartan (Primary)
  • Indications Adult respiratory distress syndrome; COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms PRAETORIAN-COVID
  • Most Recent Events

    • 25 May 2020 Planned End Date changed from 1 Oct 2021 to 1 Dec 2021.
    • 25 May 2020 Planned primary completion date changed from 1 Oct 2020 to 1 Dec 2020.
    • 07 May 2020 Planned End Date changed from 1 Aug 2021 to 1 Oct 2021.

Trial Overview

Purpose

To investigate the effect of the valsartan in comparison to placebo in patients With SARS-COV-2 Infection Disease.

Primary Endpoints

first occurrence of intensive care unit admission, mechanical ventilation or death

description: Death is defined as all-cause mortality
time_frame: within 14 days

Other Endpoints

Death

description: All-cause mortality; and time to all-cause mortality
time_frame: Within 14 days, 30 days, 90 days and at 1 year

Mechanical ventilation

description: Occurrence of mechanical ventilation and time to ventilation
time_frame: within 14 days

Intensive care unit admission

description: Occurrence of ICU admission and time to admission
time_frame: within 14 days

Occurrence of acute kidney injury

description: Defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2
time_frame: Within 14 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
Adult respiratory distress syndrome prevention -
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 651

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient Inclusion Criteria

Inclusion Criteria - Adult (age ≥ 18 years) - Admitted to the hospital of any participating center - Confirmed SARS-CoV-2 infection with either: positive laboratory test for SARS-CoV-2* ; or positive CT thorax diagnostic for SARS-CoV-2 infection according to the prevailing criteria - Randomization: - Within 24 hours of confirmed in-hospital SARS-CoV-2 infection diagnosis OR - within 24 hours of hospital admission in case of pre-hospital confirmed SARS-CoV-2 infection. - In case there is a lack of laboratory tests for SARS-CoV-2 in the participating center of the potentially eligible patient, a positive laboratory test for SARS-CoV-2 will be no longer required. In that case, the potentially eligible patient needs to meet the prevailing criteria for the diagnosis of SARS-CoV-2 infection of that participating center, such as typical abnormalities on pulmonary CT in the setting of high clinical suspicion of SARS-CoV-2 infection.

Patient Exclusion Criteria

- Admitted to ICU prior to randomization - Currently taking an ARB or angiotensin-receptor-neprilysin-inhibitor (ARNI) - Use of other investigational drugs at the time of enrollment - Prior reaction or intolerance to an ARB or ARNI; or severe intolerance to an ACEi, defined as angio-oedema requiring medical intervention - Systolic blood pressure < 105mmHg or diastolic blood pressure <65mmHg - Potassium greater than 5.5 mEq/L within 4 weeks of study enrollment. - Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 within 4 weeks of study initiation - A known history of renal artery stenosis - AST and/or ALT > 3 times the upper limit of normal within 4 weeks of study enrollment. In case of mild to moderate liver dysfunction valsartan dosage will be limited to a maximum of 80mg - Severe liver dysfunction, biliary cirrhosis or cholestasis - Severe volume depletion or severe acute kidney injury that, in the opinion of the investigator, would preclude administration of valsartan - Concurrent treatment with Aliskiren - Inability to obtain informed consent - Pregnancy or breastfeeding - In females of childbearing age, unwillingness to use birth control or to be sexually abstinent for the duration of the study

Trial Details

Identifiers

Identifier Owner
NCT04335786 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001320-34 European Clinical Trials Database
NL73547-091-20 -
2020-6384 -

Trial Dates

  • Initiation Dates

    Planned : 01 Apr 2020

    Actual : 17 Apr 2020

  • Primary Completion Dates

    Planned : 01 Dec 2020

  • End Dates

    Planned : 01 Dec 2021

Substudies/Extensions

• Age group (above/below median age; above/below 65 years) • Gender (male/female) • Admission hospital (study site) • Hypertension (yes/no) • Diabetes (yes/no) • Saturation at baseline (above/below median) • Treatment with ACE-inhibition (yes/no) • Viral load (high/low)

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase IV
  • Location Netherlands
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
ValsartanPrimary Drug Oral Tablet

Active treatment arm

Valsartan at a dosage and frequency titrated to blood pressure with 80mg or 160mg tablets up to a maximum dose of 160mg b.i.d.
Drug: Valsartan (Diovan) (At the time of randomization each participant will start with study treatment and continue up to 14 days, or up to reaching the primary endpoint, or up to hospital discharge, or up to any of the pre-defined stopping criteria.
Study drug dosages will be titrated to blood pressure with a maximum of 160mg b.i.d.)

Placebo arm

Matching 80mg or 160mg placebo tablets at a dosage and frequency titrated to systolic blood pressure
Drug: Placebo oral tablet (At the time of randomization each participant will start with study treatment and continue up to 14 days, or up to reaching the primary endpoint, or up to hospital discharge, or up to any of the pre-defined stopping criteria.)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Cardiology Research Department

Geert Grooteplein Zuid 10
Nijmegen
Postcode: 6525 GA
Netherlands
Telephone: +31621137538
show details
Radboudumc Netherlands
Corstiaan A Den Uil, MD PhD Erasmus MC Netherlands
Frank Gommans, MD PhD
frank.gommans@radboudumc.nl
show details
, Radboud University
-
Niels van Royen, MD PhD Radboud University
-
Peter de Jager, MD PhD Jeroen Bosch Ziekenhuis Netherlands
Ragnar Lunde Laurentius Ziekenhuis Netherlands
Regina A Carels, MD Ikazia Ziekenhuis Netherlands
Robert-Jan Hassing, MD PhD Rijnstate Netherlands
Roland RJ van Kimmenade, MD PhD
+31243616785 Roland.vanKimmenade@radboudumc.nl
show details
, Radboud University
-
Roland van Kimmenade, MD PhD Radboudumc Netherlands

Centres

Centre Name Location Trial Centre Country
-
-
-
Erasmus MC Rotterdam Netherlands
Ikazia Ziekenhuis Rotterdam Netherlands
Jeroen Bosch Ziekenhuis 's-Hertogenbosch Netherlands
Laurentius Ziekenhuis Roermond Netherlands
Radboud University
-
-
Radboud University
-
-
Radboudumc Nijmegen Netherlands
Radboudumc Nijmegen Netherlands
Rijnstate Arnhem Netherlands

Trial History

Event Date Event Type Comment
28 May 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 28 May 2020
25 May 2020 Completion date Planned End Date changed from 1 Oct 2021 to 1 Dec 2021. Updated 28 May 2020
25 May 2020 Other trial event Planned primary completion date changed from 1 Oct 2020 to 1 Dec 2020. Updated 28 May 2020
16 May 2020 Other trial event Last checked against European Clinical Trials Database record. Updated 18 May 2020
07 May 2020 Completion date Planned End Date changed from 1 Aug 2021 to 1 Oct 2021. Updated 11 May 2020
07 May 2020 Other trial event Planned primary completion date changed from 1 Jul 2020 to 1 Oct 2020. Updated 11 May 2020
20 Apr 2020 Other trial event New source identified and integrated (European Clinical Trials Database: EudraCT2020-001320-34) Updated 20 Apr 2020
15 Apr 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 20 Apr 2020
08 Apr 2020 New trial record New trial record Updated 08 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
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