NCT04351724

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)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-04-16
• Primary completion: 2021-12-01
• Completion: 2022-03-31
• First posted: 2020-04-17
• Last updated: 2021-03-02

Locations

9 sites across 1 country: Austria