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Austrian CoronaVirus Adaptive Clinical Trial (COVID-19) | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

Austrian CoronaVirus Adaptive Clinical Trial (COVID-19)

A Multicenter, Randomized, Active Controlled, Open Label, Platform Trial on the Efficacy and Safety of Experimental Therapeutics for Patients With COVID-19 (Caused by Infection With Severe Acute Respiratory Syndrome Coronavirus-2)

NCT04351724•Medical University of Vienna

View on ClinicalTrials.gov

Summary

The Austrian Coronavirus Adaptive Clinical Trial (ACOVACT) is a randomized, controlled, multicenter, open-label basket trial that aims to compare various antiviral treatments for COVID-19. Moreover three substudies have been integrated. Currently, patients will be randomized to receive (hydroxy-)chloroquine (Treatment stopped after reports of safety issues), lopinavir/ritonavir, remdesivir or standard of care. Moreover, these patients are eligible for substudy A (randomized to rivaroxaban 5mg 1-0-1 vs. standard of care), substudy B (renin-angiotensin (RAS) blockade vs. no RAS blockade for patients with blood pressure \>120/80mmHg), and substudy C (asunercept vs standard of care, pentglobin vs. standard of care for patients with respiratory deterioration and high inflammatory biomarkers). Endpoints were chosen based on the master protocol published by the World Health Organisation and include a 7-point scale of clinical performance, mortality, oxygen requirement (both dose and type), duration of hospitalization, viral load and safety.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Laboratory confirmed (i.e. PCR-based assay) infection with SARS-CoV-2 (ideally but not necessarily
•≤72 hours before randomization for "antiviral" treatments) OR radiological signs of COVID-19 in chest X-ray or computed tomography
•Hospitalisation due to SARS-CoV-2 infection, except for sub-study B, which may also include outpatients with COVID-19
•Requirement of oxygen support (due to oxygen saturation \<94% on ambient air or \>3% drop in case of chronic obstructive lung disease)
•Informed Consent obtained, the patient understands and agrees to comply with the planned study procedures, except for sub-study C: obtaining informed consent may be impossible due to the severe condition of the patient and may be waived
•≥18 years of age
•Sub-study A: not on chronic anticoagulation Sub-study B: Sub-study B: blood pressure ≥130/85mmHg in 2 consecutive measurements OR patients with established and treated hypertension
•Sub-study B: Control group 1: Patients with suspicion of but negative tests for COVID-19. This group may consist of hospitalized and non-hospitalized patients.
•Sub-study B: healthy volunteers
•Sub-study C: Signs of respiratory deterioration and progressing inflammation: need for oxygen supplementation, non-invasive ventilation, high-flow oxygen devices or mechanical ventilation AND CRP levels \>5mg/dL (for Pentaglobin only) and ICU admission (for Pentaglobin only)
+1 more criteria

Exclusion Criteria

•Moribund, or estimated life expectancy \<1 month (e.g. terminal cancer, etc.)
•Patient does not qualify for intensive care, based on local triage criteria
•Pregnancy or breastfeeding
•Severe liver dysfunction (e.g. ALT/AST \> 5 times upper limit of normal)
•Stage 4 chronic kidney disease or requiring dialysis for direct anticoagulant treatment
•Allergy or intolerances to experimental substance (ineligibility for treatment arm), for Asunercept known hereditary fructose intolerance
•Anticipated discharge from hospital within 48 hours (for any given reason)
•Contraindications for treatment arm 2 (lopinavir/ritonavir): severe hepatic impairment, CYP3A4/5 metabolized drugs, as deemed relevant by treating physicians
•Contraindications for treatment arm 3 (remdesivir): \<40kg bodyweight
•Known active HIV or viral hepatitis
+6 more criteria

Locations (9)

Medical University of Innsbruck

Innsbruck, Tyrol, Austria

Medical University of Graz

Graz, Austria

Kepler University Hospital

Linz, Austria

Medical University of Vienna

Vienna, Austria

Wilhelminenspital

Vienna, Austria

SMZ Süd Kaiser Franz Josef Spital

Vienna, Austria

KH Hietzing

Vienna, Austria

SMZ Baumgartner Höhe Otto Wagner Spital

Vienna, Austria

SMZ Ost Donauspital

Vienna, Austria

Key Dates

Start Date

April 16, 2020

Primary Completion Date

December 1, 2021

Completion Date

March 31, 2022

Last Updated

March 2, 2021

Enrollment

500

ESTIMATED participants

Conditions

COVID-19

Interventions

Chloroquine or Hydroxychloroquine

DRUG

Lopinavir/Ritonavir

DRUG

Best standard of care

OTHER

Rivaroxaban

DRUG

Thromboprophylaxis

DRUG

Candesartan

DRUG

non-RAS blocking antihypertensives

DRUG

Remdesivir

DRUG

Asunercept 400mg

DRUG

Asunercept 100mg

DRUG

Asunercept 25mg

DRUG

Pentaglobin

DRUG

Contacts

Bernd Jilma, MD

CONTACT

+4314040029810 klin-pharmakologie@meduniwien.ac.at

Christian Schörgenhofer, MD, PHD

CONTACT

+4314040029810 klin-pharmakologie@meduniwien.ac.at

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Austrian CoronaVirus Adaptive Clinical Trial (COVID-19)

Inclusion Criteria

Exclusion Criteria

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