Austrian CoronaVirus Adaptive Clinical Trial (COVID-19)

  • STATUS
    Recruiting
  • End date
    Mar 31, 2022
  • participants needed
    500
  • sponsor
    Medical University of Vienna
Updated on 9 March 2021
COPD
mechanical ventilation
lopinavir/ritonavir
angiotensin
covid-19
SARS
oximetry
hydroxychloroquine
oxygen supplementation
antiviral drugs
antihypertensive drugs
chloroquine
coronavirus infection

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.

Details
Condition *COVID-19, Covid-19
Treatment Lopinavir/Ritonavir, Rivaroxaban, Candesartan, Best Standard of Care, Clazakizumab, Thromboprophylaxis, Remdesivir, Chloroquine or Hydroxychloroquine, non-RAS blocking antihypertensives, placebo for clazakizumab, Asunercept 400mg, Asunercept 100mg, Asunercept 25mg, Pentaglobin
Clinical Study IdentifierNCT04351724
SponsorMedical University of Vienna
Last Modified on9 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Laboratory confirmed (i.e. PCR-based assay) infection with SARS-CoV-2 (ideally
but not necessarily
hours before randomization for "antiviral" treatments) OR radiological
signs of COVID-19 in chest X-ray or computed tomography
years of age
Hospitalisation due to SARS-CoV-2 infection, except for sub-study B, which may also include outpatients with COVID-19
For female patients with childbearing potential: willingness to perform effective measures of contraception during the study
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
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)

Exclusion Criteria

Moribund, or estimated life expectancy <1 month (e.g. terminal cancer, etc.)
Pregnancy or breastfeeding
Patient does not qualify for intensive care, based on local triage criteria
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
Substudy A contraindications for rivaroxaban: active bleeding or bleeding diathesis, lesion or condition considered as major risk factor for bleeding, recent brain or spinal injury, recent brain or spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, major intraspinal or intracerebral vascular abnormalities, ongoing therapeutic anticoagulation, which will be continued, according to clinical practice
Sub-study B contraindications for nitrendipine: chronic heart failure, allergies, hypersensitivities and intolerances, severe hepatic impairment and/or cholestasis, concomitant therapy with aliskirencontaining medications (for patients with diabetes mellitus or a GFR<60ml/min/1.73m2), known significant bilateral renal artery stenosis or renal artery stenosis of a solitary kidney
Sub-study C contraindications for IL-6 blockade: Contraindications: allergies and intolerances, active untreated diverticulitis, inflammatory bowel disease, any treatment with an IL-6 or IL-6R blocking drug (e.g. tocilizumab, sarilumab, siltuximab) <30 days before study inclusion
Sub-study C: Known active tuberculosis
Asunercept: females of childbearing potential
Sub-study C with Pentaglobin: Contraindications to Pentaglobin
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