Austrian CoronaVirus Adaptive Clinical Trial (COVID-19)

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.

Conditions

• COVID-19

Interventions

DRUG

Chloroquine or Hydroxychloroquine

Hydroxychloroquine 200mg 2-0-2 on day 1 followed by 200mg 1-0-1, or Chloroquine 250mg 2-0-2, as available

DRUG

Lopinavir/Ritonavir

Lopinavir/Ritonavir 200mg/50mg 2-0-2

OTHER

Best standard of care

best standard of care

DRUG

Rivaroxaban

2.5mg 2-0-2 or 10mg 1/2-0-1/2, as applicable

DRUG

Thromboprophylaxis

as local standard, most likely to be low molecular weight heparin

DRUG

Candesartan

starting dose 4mg once daily, titrated to normotension

DRUG

non-RAS blocking antihypertensives

This excludes angiotensin converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (AT-blockers, sartans) and includes alpha-receptor antagonists, calcium antagonists, amongst others

DRUG

Remdesivir

200mg on day 1, thereafter 100mg for a total of 5-10 treatment days, according to local standards

DRUG

Asunercept 400mg

asunercept 400mg once per week, up to 4 doses in total

DRUG

Asunercept 100mg

asunercept 100mg once per week, up to 4 doses in total

DRUG

Asunercept 25mg

asunercept 25mg once per week, up to 4 doses in total

DRUG

Pentaglobin

7ml/kg/day for 12h for 5 days

Sponsors & Collaborators

• Kaiser Franz Josef Hospital

  collaborator OTHER

• SMZ-Ost Donauspital

  collaborator OTHER

• Otto Wagner Hospital

  collaborator OTHER

• Hospital Hietzing

  collaborator OTHER

• Wilhelminenspital Vienna

  collaborator OTHER

• Medical University Innsbruck

  collaborator OTHER

• Medical University of Graz

  collaborator OTHER

• Kepler University Hospital

  collaborator OTHER

• Medical University of Vienna

  lead OTHER

Principal Investigators

• Bernd Jilma, MD · Medical University of Vienna

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-04-16

Primary Completion

2021-12-01

Completion

2022-03-31

Countries

• Austria

Study Locations