Covid19Phase 1NCT05065645

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled APN01 Developed as Treatment for COVID-19

A Phase 1 study testing Angiotensin Converting Enzyme 2 and Sodium chloride in people with Covid19, run by Apeiron Biologics at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Covid19
What is being tested?: Angiotensin Converting Enzyme 2 and Sodium chloride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteAustria
Study dates: 19 Oct 2021to 27 May 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males and females between 18 to 55 years of age, inclusive, at the screening visit.
Subject voluntarily agrees to participate in this study and signs an Ethics Committee approved informed consent prior to performing any of the screening visit procedures.
Subject is able to understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff.
Women of childbearing potential must have a negative pregnancy test, should not be breastfeeding, and must be willing to use highly effective methods of contraception for at least 1 month before, while participating in this study and until 1 month after the end of the treatment. The following terms of contraception apply:
4.1. Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
4.2. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study intervention. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.

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4.3. Sterilization of male partner (at least 6 months prior to Screening) with post-procedural semen specimen to verify a successful procedure (the report of the male partner will not be collected since the partner is not study participant). For female participants on the study, the vasectomized male partner should be the sole partner for that participant.
4.4. Placement of an intrauterine device or intrauterine system, or other forms of non-hormonal contraception that have comparable efficacy (failure rate <1%).
4.5. Women who are postmenopausal are not required to use contraception. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range (FSH > 40 U/ml at Screening) must be used to confirm a postmenopausal state.
Male subject must agree to stay abstinent or must use together with his female partner(s) use a form of highly effective contraceptive from the time of signing the informed consent form (ICF) until up to 3 months after receiving the study drug.
Nonsmokers (and/or no use of other nicotine products during 1 year before screening visit).
Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at the screening visit.
Healthy with no clinically significant findings, determined by medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations) at Screening.
Forced expiratory volume in 1 second (FEV1) ≥80%.

Who cannot join

Female subjects who are breastfeeding or female subjects with a positive pregnancy test at the screening visit or admission.
Study participant has a history of an anaphylactic reaction to study drug or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation.
Subject has used an investigational drug within 30 days (or 5 half-lives whichever is longer) prior to the first dose of study drug.
Subject is on any regular (more than 4 days a week) prescription or nonprescription over the counter medication, topical medications, vitamins, dietary or herbal (occasional use of acetaminophen, paracetamol or ibuprofen allowed).
Subject has positive urine test for drugs of abuse at the screening visit or admission.
Regular consumption of alcohol within 6 months prior to Screening (> 7 drinks/week for females, > 14 drinks/week for males where 1 drink = 5 ounces [150 ml] of wine or 12 ounces [360 ml] of beer or 1.5 ounces [45 ml] of hard liquor), or use of illicit substances (such as marijuana) within 3 months prior to the screening visit.

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Subject has positive test for SARS-CoV-2 antigen or real-time RT-PCR, HBsAg, anti-HBc antibodies, HCV antibody, and/or HIV antibody at screening visit.
Donation or loss of 450 ml or more of blood within 4 weeks or 250 ml of plasma within 4 weeks prior to initial dosing.
Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, mental or other medical disorder, including cirrhosis or malignancy.
Subject has a history of a psychiatric disorder that will affect the subject's ability to participate in the study as determined by the Investigator.
Subject has a clinically relevant abnormal ECG.
Subject has clinically relevant abnormal laboratory values at the discretion of the Investigator.
Subject has hypertension with a mean systolic BP >150 mmHg or mean diastolic BP >100 mm Hg. Screening and admission tests may be repeated once if abnormal.
Subject has acute, clinically significant illness within 30 days prior to admission, or any other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study.
Subject is an employee of the clinical research team (any APEIRON Biologics AG or study center employee).
Subject is unable to understand the protocol requirements, instructions, study-related restrictions, nature, scope and possible consequences of the clinical study. Subject is unlikely to comply with the protocol requirements, instructions and study-related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study.
Subject judged inappropriate as participant for the study by the Investigator for other reasons.
Any signs of respiratory tract infection within 6 weeks of screening.
Subject previously diagnosed with COVID-19 pneumonia.
Presence of acute infection in the preceding 14 days, or presence of fever (> 37.9°C oral or tympanic temperature assessment), or acute symptoms of any severity on the scheduled date of admission.
Subject who has a current bacterial, parasitic, fungal, or viral infection; any infection requiring hospitalization or intravenous antibiotics within 6 weeks prior to Screening.
Subject has any pathological condition of the oro-laryngeal or respiratory tract that hinders use of nebulizer.
Any of the following laboratory abnormalities:
White blood cells, hemoglobin, platelets, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ±15% outside of normal limits. Alkaline phosphatase (ALP), urea and creatinine above 15% outside of normal limits.
Subject has received or plans to receive a coronavirus vaccine, or any other vaccine, within 7 days prior to the first dose of study drug or during the study.

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Vienna
Vienna, 1090

Other trials in Austria

About this study

Official title: A Phase I, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Inhaled APN01

APN01 is a soluble recombinant form of the human angiotensin-converting enzyme 2 (rhACE2) that is currently under development as a therapy for corona-virus-disease 2019 (COVID-19). By effectively mimicking ACE2 within the body, APN01 is designed to block the SARS-CoV-2 from binding to the ACE2 receptor and infecting cells while at the same time downregulating the renin-aldosterone-angiotensin system (RAAS) to help prevent inflammation and organ injury - critical components involved in the cytokine storm response. ACE2 is the key entry receptor for the SARS-CoV-2. Competitive binding by exogenous angiotensin-converting enzyme 2 (ACE2) may block viral entry, thereby decreasing viral replication in ACE2 expressing organs and protecting the lungs and distal organs from injury induced by SARS-CoV-2.

APN01 has been developed as an IV agent to treat acute lung injury and pulmonary arterial hypertension, and moderate to severe COVID-19 infection. Encouraged by the favorable safety profile of IV APN01, we have developed the nebulized APN01 formulation to deliver the drug directly to the respiratory tract, where the virus is mainly found, decreasing systemic exposure and increasing local pulmonary concentration. APN01 intravenously and as inhalation in preclinical studies has been well tolerated with no overall difference in clinical studies from placebo in human trials to date.

This study will investigate nebulized APN01 safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity before stepping forward in proof-of-concept studies in patients with COVID-19.

Conditions: Covid19
Being tested: Angiotensin Converting Enzyme 2, Sodium chloride
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Angiotensin Converting Enzyme 2Drug
Also called Inhalation solution
SAD: single dose; MAD: dosage 2x daily for 7 days
Sodium chlorideDrug
Also called Inhalation solution
SAD: single dose; MAD: dosage 2x daily for 7 days

Study groups in NCT05065645
Study group	Role	What they receive
APN01	Active comparator	Angiotensin Converting Enzyme 2: 1.25 mg/ml, 2.5 mg/ml or 5 mg/ml Receives: Drug: Angiotensin Converting Enzyme 2
NaCl	Placebo comparator	Sodium Chloride: 0.9% NaCl solution Receives: Drug: Sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events
Incidence of adverse events (AEs), serious AEs (SAEs), study withdrawals due to AEs, adverse drug reactions (ADRs), and all-cause death,
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Vital signs: Supine blood pressure assessed by systolic and diastolic blood pressure in mmHg
Systolic and diastolic blood pressure in mmHg
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Vital signs: Resting pulse rate measured in beats per minute
Resting pulse rate measured in beats per minute
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Vital signs: Body temperature assessed contactless via TriTemp thermometer in degree C
Body temperature measured in degree C
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Vital signs: Respiratory rate measured in breaths/min
Respiratory rate measured in breaths/min
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Vital signs: Peripheral oxygen saturation (SaO2) measured in %
Peripheral oxygen saturation (SaO2) measured in %
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Clinical laboratory tests: Clinically significant changes of hematology, clinical chemistry and coagulation assessed via blood sample collection
Clinically significant changes of hematology, clinical chemistry, coagulation and urinalysis assessed via blood sample collection
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Clinical laboratory tests: Clinically significant changes of urinalysis measurement assessed via urin collection
Clinically significant changes of urinalysis measurement assessed via urin collection
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the general appearance
Abnormal findings of general appearance
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the ears
Abnormal findings of the ears
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the nose
Abnormal findings of the nose
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the head
Abnormal findings of the head
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the eyes
Abnormal findings of the eyes
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the dermatologic system
Abnormal findings of the dermatologic system
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the mouth/throat/neck
Abnormal findings of the mouth/throat/neck
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the thyroid
Abnormal findings of the thyroid
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the lymph nodes
Abnormal findings of the lymph nodes
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the respiratory system
Abnormal findings of the respiratory system
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the cardiovascular system
Abnormal findings of the cardiovascular system
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the gastrointestinal system
Abnormal findings of the gastrointestinal system
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the extremities
Abnormal findings of the extremities
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the musculoskeletal system
Abnormal findings of the musculoskeletal system
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the neurologic system
Abnormal findings of the neurologic system
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Physical examination: Abnormal findings of the psychiatric system
Abnormal findings of the psychiatric system
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Heart function: QT interval corrected for heart rate (QTc) (Bazett's correction [QTcB]) in msec assessed via Twelve lead ECG
Twelve lead ECG: QT interval corrected for heart rate (QTc) (Bazett's correction [QTcB]) measured in msec
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Pulmonary function assessed via Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) measured in L by spirometry
Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) measured in L
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Pulmonary function assessed via Peak expiratory flow (PEF) measured in L/s by spirometry
Peak expiratory flow (PEF) measured in L/s
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Pulmonary function assessed via FEV1/FVC ratio measured in % by spirometry
FEV1/FVC ratio measured in %
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Pulmonary function assessed via Total lung capacity (TLC) and Residual volume (RV) measured in L by body plethysmography
Total lung capacity (TLC) and Residual volume (RV) measured in L
Measured: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Fractional Exhaled Nitric Oxide (FeNO) levels measured in parts per billion (ppb) - in MAD cohort only
Fractional Exhaled Nitric Oxide (FeNO) levels measured in parts per billion (ppb)
Measured: MAD cohort: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 202127 May 2022

First posted4 Oct 2021
Study start19 Oct 2021
Primary completion27 May 2022
Study completion27 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05065645
Sponsor's protocol ID: APN01-01-INHAL
Status last verified: Feb 2022
First submitted: 30 Aug 2021
Last updated: 23 Sep 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Bauer M, Jorda A, Al-Jalali V, Wolfl-Duchek M, Bergmann F, Nussbaumer-Proll A, Steindl A, Gugenberger R, Bischof S, Wimmer D, Idzko M, Zeitlinger M. Phase I dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of an inhaled recombinant human ACE2. ERJ Open Res. 2024 Feb 19;10(1):00567-2023. doi: 10.1183/23120541.00567-2023. eCollection 2024 Jan.
PubMed 38375429
Shoemaker RH, Panettieri RA Jr, Libutti SK, Hochster HS, Watts NR, Wingfield PT, Starkl P, Pimenov L, Gawish R, Hladik A, Knapp S, Boring D, White JM, Lawrence Q, Boone J, Marshall JD, Matthews RL, Cholewa BD, Richig JW, Chen BT, McCormick DL, Gugensberger R, Holler S, Penninger JM, Wirnsberger G. Development of an aerosol intervention for COVID-19 disease: Tolerability of soluble ACE2 (APN01) administered via nebulizer. PLoS One. 2022 Jul 11;17(7):e0271066. doi: 10.1371/journal.pone.0271066. eCollection 2022.
PubMed 35816490

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Inhaled APN01
ClinicalTrials.gov ID: NCT05065645
Acronym / sponsor ID: APN01-01-INHAL
Conditions: Covid19
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Apeiron BiologicsIndustry (pharma, biotech, devices)
Collaborators: Apeiron Respiratory Therapies GmbH
Study start: 19 Oct 2021 (actual)
Primary completion: 27 May 2022 (actual)
Study completion: 27 May 2022 (actual)
First posted: 4 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will investigate nebulized APN01 safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity before stepping forward in proof-of-concept studies in patients with COVID-19.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
APN01	Active comparator	Drug: Angiotensin Converting Enzyme 2Angiotensin Converting Enzyme 2: 1.25 mg/ml, 2.5 mg/ml or 5 mg/ml
NaCl	Placebo comparator	Drug: Sodium chlorideSodium Chloride: 0.9% NaCl solution

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Healthy males and females between 18 to 55 years of age, inclusive, at the screening visit.
Subject voluntarily agrees to participate in this study and signs an Ethics Committee approved informed consent prior to performing any of the screening visit procedures.
Subject is able to understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff.
Women of childbearing potential must have a negative pregnancy test, should not be breastfeeding, and must be willing to use highly effective methods of contraception for at least 1 month before, while participating in this study and until 1 month after the end of the treatment. The following terms of contraception apply:
4.1. Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

Key exclusion criteria (25 listed)

Female subjects who are breastfeeding or female subjects with a positive pregnancy test at the screening visit or admission.
Study participant has a history of an anaphylactic reaction to study drug or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation.
Subject has used an investigational drug within 30 days (or 5 half-lives whichever is longer) prior to the first dose of study drug.
Subject is on any regular (more than 4 days a week) prescription or nonprescription over the counter medication, topical medications, vitamins, dietary or herbal (occasional use of acetaminophen, paracetamol or ibuprofen allowed).
Subject has positive urine test for drugs of abuse at the screening visit or admission.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Angiotensin Converting Enzyme 2Also: Inhalation solutionSAD: single dose; MAD: dosage 2x daily for 7 days	Drug	APN01
Sodium chlorideAlso: Inhalation solutionSAD: single dose; MAD: dosage 2x daily for 7 days	Drug	NaCl

Primary outcome

Adverse events
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Incidence of adverse events (AEs), serious AEs (SAEs), study withdrawals due to AEs, adverse drug reactions (ADRs), and all-cause death,
Vital signs: Supine blood pressure assessed by systolic and diastolic blood pressure in mmHg
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Systolic and diastolic blood pressure in mmHg
Vital signs: Resting pulse rate measured in beats per minute
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Resting pulse rate measured in beats per minute
Vital signs: Body temperature assessed contactless via TriTemp thermometer in degree C
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Body temperature measured in degree C
Vital signs: Respiratory rate measured in breaths/min
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Respiratory rate measured in breaths/min
Vital signs: Peripheral oxygen saturation (SaO2) measured in %
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Peripheral oxygen saturation (SaO2) measured in %
Clinical laboratory tests: Clinically significant changes of hematology, clinical chemistry and coagulation assessed via blood sample collection
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Clinically significant changes of hematology, clinical chemistry, coagulation and urinalysis assessed via blood sample collection
Clinical laboratory tests: Clinically significant changes of urinalysis measurement assessed via urin collection
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Clinically significant changes of urinalysis measurement assessed via urin collection
Physical examination: Abnormal findings of the general appearance
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of general appearance
Physical examination: Abnormal findings of the ears
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the ears
Physical examination: Abnormal findings of the nose
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the nose
Physical examination: Abnormal findings of the head
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the head
Physical examination: Abnormal findings of the eyes
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the eyes
Physical examination: Abnormal findings of the dermatologic system
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the dermatologic system
Physical examination: Abnormal findings of the mouth/throat/neck
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the mouth/throat/neck
Physical examination: Abnormal findings of the thyroid
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the thyroid
Physical examination: Abnormal findings of the lymph nodes
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the lymph nodes
Physical examination: Abnormal findings of the respiratory system
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the respiratory system
Physical examination: Abnormal findings of the cardiovascular system
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the cardiovascular system
Physical examination: Abnormal findings of the gastrointestinal system
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the gastrointestinal system
Physical examination: Abnormal findings of the extremities
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the extremities
Physical examination: Abnormal findings of the musculoskeletal system
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the musculoskeletal system
Physical examination: Abnormal findings of the neurologic system
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the neurologic system
Physical examination: Abnormal findings of the psychiatric system
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Abnormal findings of the psychiatric system
Heart function: QT interval corrected for heart rate (QTc) (Bazett's correction [QTcB]) in msec assessed via Twelve lead ECG
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Twelve lead ECG: QT interval corrected for heart rate (QTc) (Bazett's correction [QTcB]) measured in msec
Pulmonary function assessed via Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) measured in L by spirometry
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) measured in L
Pulmonary function assessed via Peak expiratory flow (PEF) measured in L/s by spirometry
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Peak expiratory flow (PEF) measured in L/s
Pulmonary function assessed via FEV1/FVC ratio measured in % by spirometry
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
FEV1/FVC ratio measured in %
Pulmonary function assessed via Total lung capacity (TLC) and Residual volume (RV) measured in L by body plethysmography
Time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks
Total lung capacity (TLC) and Residual volume (RV) measured in L
Fractional Exhaled Nitric Oxide (FeNO) levels measured in parts per billion (ppb) - in MAD cohort only
Time frame: MAD cohort: 3 weeks
Fractional Exhaled Nitric Oxide (FeNO) levels measured in parts per billion (ppb)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
Derived from this study: PubMed 38375429Bauer M, Jorda A, Al-Jalali V, Wolfl-Duchek M, Bergmann F, Nussbaumer-Proll A, Steindl A, Gugenberger R, Bischof S, Wimmer D, Idzko M, Zeitlinger M. Phase I dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of an inhaled recombinant human ACE2. ERJ Open Res. 2024 Feb 19;10(1):00567-2023. doi: 10.1183/23120541.00567-2023. eCollection 2024 Jan.
Derived from this study: PubMed 35816490Shoemaker RH, Panettieri RA Jr, Libutti SK, Hochster HS, Watts NR, Wingfield PT, Starkl P, Pimenov L, Gawish R, Hladik A, Knapp S, Boring D, White JM, Lawrence Q, Boone J, Marshall JD, Matthews RL, Cholewa BD, Richig JW, Chen BT, McCormick DL, Gugensberger R, Holler S, Penninger JM, Wirnsberger G. Development of an aerosol intervention for COVID-19 disease: Tolerability of soluble ACE2 (APN01) administered via nebulizer. PLoS One. 2022 Jul 11;17(7):e0271066. doi: 10.1371/journal.pone.0271066. eCollection 2022.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Angiotensin Converting Enzyme 2 and Sodium chloride in people with Covid19, run by Apeiron Biologics at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: SAD cohort: 2 weeks, MAD cohort: 3 weeks). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05065645, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.