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
Results First Posted : August 2, 2021
Last Update Posted : August 2, 2021
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Sponsor:
Apeiron Biologics
Information provided by (Responsible Party):
Apeiron Biologics
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
COVID-19 |
Interventions |
Drug: RhACE2 APN01 Drug: Physiological saline solution |
Enrollment | 185 |
Participant Flow
Recruitment Details | 185 Patients were screened of whom 181 patients were randomized. |
Pre-assignment Details |
Arm/Group Title | Group A (Active) APN01 | Group B (Placebo Control) |
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Patients were treated with APN01 (Recombinant human angiotensin-converting enzyme 2 [rhACE2]) intravenously twice daily (BID). | Patients were treated with placebo (physiological saline solution) intravenously twice daily (BID). |
Period Title: Overall Study | ||
Started [1] | 91 | 90 |
Treated | 88 | 90 |
Completed | 77 | 83 |
Not Completed | 14 | 7 |
Reason Not Completed | ||
Death | 8 | 4 |
Lost to Follow-up | 2 | 0 |
Protocol Violation | 1 | 0 |
Withdrawal by Subject | 1 | 1 |
Health-threatening condition | 0 | 1 |
Adverse Event | 0 | 1 |
Erroneously randomized | 2 | 0 |
[1]
Patients randomized.
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Baseline Characteristics
Arm/Group Title | Group A (Active) APN01 | Group B (Placebo Control) | Total | |
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Patients were treated with APN01 (Recombinant human angiotensin-converting enzyme 2 [rhACE2]) intravenously twice daily (BID). | Patients were treated with placebo (physiological saline solution) intravenously twice daily (BID). | Total of all reporting groups | |
Overall Number of Baseline Participants | 88 | 90 | 178 | |
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All randomized patients who received at least 1 dose of investigational medicinal product (IMP).
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 88 participants | 90 participants | 178 participants | |
59.6 (11.3) | 58.5 (12.4) | 59.0 (11.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 88 participants | 90 participants | 178 participants | |
Female |
33 37.5%
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31 34.4%
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64 36.0%
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Male |
55 62.5%
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59 65.6%
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114 64.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 88 participants | 90 participants | 178 participants | |
Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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Not Hispanic or Latino |
88 100.0%
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90 100.0%
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178 100.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 88 participants | 89 participants | 177 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
1 1.1%
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1 1.1%
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2 1.1%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
1 1.1%
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0 0.0%
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1 0.6%
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White |
86 97.7%
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88 98.9%
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174 98.3%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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[1]
Measure Analysis Population Description: Data of 1 patient in the placebo group are missing.
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Austria | Number Analyzed | 88 participants | 90 participants | 178 participants |
19 | 20 | 39 | ||
Germany | Number Analyzed | 88 participants | 90 participants | 178 participants |
2 | 3 | 5 | ||
Russia | Number Analyzed | 88 participants | 90 participants | 178 participants |
67 | 67 | 134 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Romana Gugenberger |
Organization: | APEIRON Biologics AG |
Phone: | +4366488506236 |
EMail: | romana.gugenberger@apeiron-biologics.com |
Responsible Party: | Apeiron Biologics |
ClinicalTrials.gov Identifier: | NCT04335136 |
Other Study ID Numbers: |
APN01-01-COVID19 |
First Submitted: | April 1, 2020 |
First Posted: | April 6, 2020 |
Results First Submitted: | June 7, 2021 |
Results First Posted: | August 2, 2021 |
Last Update Posted: | August 2, 2021 |