Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19 (APN01-COVID-19)
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ClinicalTrials.gov Identifier: NCT04335136 |
Recruitment Status :
Completed
First Posted : April 6, 2020
Last Update Posted : January 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: RhACE2 APN01 Drug: Physiological saline solution | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19 |
Actual Study Start Date : | April 30, 2020 |
Actual Primary Completion Date : | December 26, 2020 |
Actual Study Completion Date : | December 26, 2020 |
Arm | Intervention/treatment |
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Active Comparator: Group A (active) APN01
Recombinant human angiotensin-converting enzyme 2 (rhACE2) - APN01
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Drug: RhACE2 APN01
Patients will be treated with APN01 intravenously twice daily (BID).
Other Names:
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Placebo Comparator: Group B (placebo control) |
Drug: Physiological saline solution
Patients will be treated with placebo intravenously twice daily (BID). |
- All Cause-death or invasive mechanical ventilation [ Time Frame: 28 days ]The primary endpoint is a composite endpoint of all cause-death or invasive mechanical ventilation up to 28 days or hospital discharge
- LDH level [ Time Frame: Day 5 ]Log transformed levels of Lactate dehydrogenase (LDH) at day 5 as a surrogate marker for organ damage (powered secondary endpoint
- Mortality [ Time Frame: 28 days ]28-day mortality (all cause-death)
- VFD [ Time Frame: 28 days ]Ventilator-free days (VFD) up to 28 days or hospital discharge
- Time to death [ Time Frame: 28 days ]Time to death (all causes)

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Hospitalized male or female
- Diagnosed to be COVID-19 POSITIV
- Signed Inform Consent Form
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335136

Principal Investigator: | Henning Bundgaard, MD. | Cap. Region's Unit of Inherited Cardiac Diseases, Faculty Health&Medical |
Responsible Party: | Apeiron Biologics |
ClinicalTrials.gov Identifier: | NCT04335136 |
Other Study ID Numbers: |
APN01-01-COVID19 |
First Posted: | April 6, 2020 Key Record Dates |
Last Update Posted: | January 22, 2021 |
Last Verified: | May 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |