NCT04335136

Brief Summary

Recombinant human angotensin-converting enzyme 2 (rhACE2) as a treatment for patients with COVID-19 to block viral entry and decrease viral replication.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Apr 2020

Geographic Reach
5 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

April 30, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2020

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 2, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

8 months

First QC Date

April 1, 2020

Results QC Date

June 7, 2021

Last Update Submit

July 29, 2021

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • All Cause-death or Invasive Mechanical Ventilation

    The primary endpoint was a composite endpoint of all cause-death or invasive mechanical ventilation up to 28 days or hospital discharge.

    28 days

Secondary Outcomes (16)

  • Lactate Dehydrogenase (LDH) Level

    Day 5

  • Mortality

    28 days

  • Ventilator-free Days (VFD)

    28 days

  • Time to Death

    28 days

  • Number of Responders, Defined as ≥2 Improvement in World Health Organization (WHO)'s 11-Point Score System at Days 7, 10, 14 and 28

    Day 7, Day 10, Day 14, Day 28

  • +11 more secondary outcomes

Study Arms (2)

Group A (active) APN01

ACTIVE COMPARATOR

Recombinant human angiotensin-converting enzyme 2 (rhACE2) - APN01

Drug: RhACE2 APN01

Group B (placebo control)

PLACEBO COMPARATOR
Drug: Physiological saline solution

Interventions

RhACE2 APN01DRUG

Patients will be treated with APN01 intravenously twice daily (BID).

Also known as: APN01, Recombinant human angiotensin-converting enzyme 2
Group A (active) APN01
Physiological saline solutionDRUG

Patients will be treated with placebo intravenously twice daily (BID).

Group B (placebo control)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized male or female
  • Diagnosed to be COVID-19 POSITIV
  • Signed Inform Consent Form

You may not qualify if:

  • Any patient whose clinical condition is deteriorating rapidly
  • Known history of positive Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
  • Pregnant females as determined by positive serum or urine hCG test prior to dosing
  • Lung transplantation
  • Pre-existing renal failure, i.e. requiring renal replacement therapy with hemodialysis or peritoneal dialysis
  • There are other uncontrolled co-morbidities that increase the risks associated with the study drug administration, that are assessed by the medical expert team as unsuitable
  • Patient in clinical trials for COVID-19 within 30 days before ICF
  • Immunocompromised patients (chemotherapy, HIV, organ transplants, stem cell transplants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Medizinische Universität Innsbruck

Innsbruck, Austria

Location

Kaiser Franz Josef Spital, 4. Medizinische Abteilung mit Infektions- und Tropenmedizin

Vienna, Austria

Location

Medizinische Universität Wien

Vienna, Austria

Location

The National University Hospital, Rigshospitalet

Copenhagen, Denmark

Location

Herlev Gentofte Hospital

Herlev, 2730, Denmark

Location

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Klinikum rechts der Isar, Technische Universität München

München, Germany

Location

Regional State Budgetary Educational Institution "Clinical Hospital № 5, Barnaul"

Barnaul, 656045, Russia

Location

State Healthcare Institution "State Clinical Hspital № 15 named after O.M. Filatov"

Moscow, 111539, Russia

Location

Moscow State Budgetary Healthcare Institution "City Clinical Hospital №52 of Health Department of Moscow"

Moscow, 123182, Russia

Location

Moscow State Budgetary Healthcare Institution "N.V. Sklifosovsky Research Institute for Emergency Medicine of Health Department of Moscow"

Moscow, 129090, Russia

Location

Saint Petersburg SBHI City Hospital 38 named after N A Semashko

Pushkin, 196600, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after I.P. Pavlov" HD RF

Ryazan, 390026, Russia

Location

Alexandrovskaya Hospital

Saint Petersburg, 193312, Russia

Location

Saint-Petersburg State Budget Healthcare Institution City Hospital 15

Saint Petersburg, 198205, Russia

Location

Federal State Budgetary Educational Institution of Higher Education " Saratov State Medical University named after V.I. Razumovsky" HD RF

Saratov, 410054, Russia

Location

Regional State Budgetary Healthcare Institution "Clinical Hospital №1"

Smolensk, 214006, Russia

Location

State budgetary institution of Healthcare of Tver region "Regional clinical hospital"

Tver', 170036, Russia

Location

Yaroslavl Regional Clinical Hospital for Military Veterans - International Centre for Gerontological Problems "Healthy Ageing"

Yaroslavl, 150047, Russia

Location

Cambridge University Hospitals NHS Trust/University of Cambridge

Cambridge, CB2 0QQ, United Kingdom

Location

Related Publications (2)

  • Chene A, Desrames A, Tomlinson A, Ruffie C, Tangy F, Gamain B. An ACE2-Based Bimodular Fusion Protein Enables Reorientation of Endogenous Anti-Epstein-Barr Virus Antibodies Toward SARS-CoV-2 Spike. J Infect Dis. 2023 Dec 20;228(12):1675-1679. doi: 10.1093/infdis/jiad329.

    PMID: 37562051DERIVED

  • Morrell ED. Tipping the Balance of Ubiquitination toward a Therapy for COVID-19. Am J Respir Cell Mol Biol. 2023 May;68(5):480-481. doi: 10.1165/rcmb.2023-0020ED. No abstract available.

    PMID: 36796097DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

alunacedase alfa

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr. Romana Gugenberger
Organization
APEIRON Biologics AG
romana.gugenberger@apeiron-biologics.com
+4366488506236

Study Officials

  • Henning Bundgaard, MD.

    Cap. Region's Unit of Inherited Cardiac Diseases, Faculty Health&Medical

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 6, 2020

Study Start

April 30, 2020

Primary Completion

December 26, 2020

Study Completion

December 26, 2020

Last Updated

August 2, 2021

Results First Posted

August 2, 2021

Record last verified: 2021-07

Locations

RU(12)GB(1)DE(2)AU(3)DK(4)