Covid19Phase 2NCT04536350
Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS
A Phase 2 study testing Aviptadil 67μg in people with Covid19 and Corona Virus Infection, run by Prof. Dr. Jörg Leuppi at 2 sites in Switzerland.
Trial summary
The world is currently experiencing a coronavirus (CoV-2) pandemic. A new (SARS)-CoV infection epidemic began in Wuhan, Hubei, China, in late 2019; originally called 2019- nCoV the virus is now known as SARSCoV- 2 and the disease it causes COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Corona Virus Infection, ARDS
- What is being tested?
- Aviptadil 67μg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 18 May 2021to 14 Jun 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19 infection diagnosed
- Risk factors for the development of an ARDS according to an adapted EALI (early acute lung injury score) ≥ 2 Points (with at least one point from the EALI score)
- EALI Score:
- 2-6l O2 supplementation to achieve a SaO2>90%: 1 point
- >6l O2 supplementation to achieve a SaO2>90%: 2 points
- Respiratory rate ≥ 30/min: 1 point
Show all 14Show fewer
- Immunosuppression: 1 Point
- Modification (for adapting for risk factors for ARDS in SARS-CoV-2 affected patients
- Arterial hypertension: 1 point
- Diabetes: 1 point
- Fever > 39°C: 1 point
- Age > 18 years
- Ability to adequate compliance with the inhalation manoeuvre
- Ability to sign the informed consent
Who cannot join
- Known or highly suspected bacterial infection (antibiotic treatment to avoid bacterial superinfection may be allowed)
- PCT ≥ 1μg/l
- Mechanical ventilation
- Inability to conduct inhalation therapy
- Hemodynamic instability with requirement of vasopressor therapy
- Severe comorbidities interfering with the safe participation at the trial according to the treating physician
- Pregnancy
- Systemic immunosuppression
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Cantonal Hospital Baselland Liestal
Liestal, Basel-Landschaft, 4410
Cantonal Hospital St.Gallen
Sankt Gallen, 9007
About this study
Official title: Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS: A Randomized, Placebo Controlled, Multicenter Trial
The world is currently experiencing a coronavirus (CoV-2) pandemic. A new (SARS)-CoV infection epidemic began in Wuhan, Hubei, China, in late 2019; originally called 2019- nCoV the virus is now known as SARSCoV- 2 and the disease it causes COVID-19. Previous CoV epidemics included severe acute respiratory syndrome (SARS)-CoV, which started in China in 2003 and Middle East respiratory syndrome (MERS)-CoV in the Middle East, which started in 2012. The mortality rates were >10% for SARS and >35% for MERS. The direct cause of death is generally due to ensuing severe atypical pneumonia and ensuing acute respiratory distress syndrome (ARDS). Pneumonia also is generally the cause of death for people who develop influenza, although the mortality rate is lower (1%-3% for the influenza A H5N1 pandemic of 1918-1919 in the United States). Risk factors for a poor outcome of SARS-CoV-2 infection have so far been found to include older age and co-morbidities including chronic cardiovascular and respiratory conditions and current smoking status. In May 2020, the FDA authorized the emergency use of remdesivir for treatment of COVID-19 disease based on topline date of two clinical trials, even though an underpowered clinical trial did not find significant improvement in COVID- 19 patients treated with remdesivir. Nevertheless, remdesivir is the first and so far, only approved treatment for COVID-19. Additionally further trials and clinical observations have not found a significant benefit of other antiviral drugs. Although the results of several studies are still pending, there is still a desperate need for an effective, safe treatment for COVID-19. Aviptadil, which is a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP), might be beneficial in patients at risk of developing ARDS. Nonclinical studies demonstrate that VIP is highly concentrated in the lung, where it reduces inflammation.
Read the detailed description
About 20% of individuals with Corona Virus disease (COVID-19) experience more severe disease characterized by significant respiratory symptoms including acute respiratory distress syndrome (ARDS). ARDS is a known lethal complication due to its low blood oxygenation levels and may result in organ failure. Until now, there are no specific vaccines or therapeutic drugs targeting SARS-CoV-2, alternative therapeutic interventions are needed to prevent and ameliorate respiratory conditions associated with COVID-19 to effectively reduce mortality and prevent ICU admissions. Aviptadil, which is a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP), might be beneficial in patients at risk of developing ARDS. Nonclinical studies demonstrate that VIP is highly concentrated in the lung, where it prevents N-methyl-D-aspartate (NMDA)-induced caspase-3 activation, inhibits IL-6 and TNFa production and protects against HCl-induced pulmonary edema. Further, in animal model systems of lung injury in mice, rats, guinea pigs, sheep, swine and dogs, Aviptadil was shown to restore barrier function at the endothelial/alveolar interface and to protect the lung and other organs from failure. In Europe, Aviptadil is approved for human use and has been shown to be safe in phase II trials for sarcoidosis, pulmonary fibrosis, bronchospasm, erectile dysfunction as well as in a phase I trial in ARDS in the past two decades. In the US, VIP has been given FDA Orphan Drug Designation for the treatment of ARDS and was admitted to the FDA Corona Virus Technology Accelerator Program. In a phase I trial of Aviptadil performed by Sami Said in the early 2000s, eight patients with severe ARDS on mechanical ventilation were treated with ascending doses of intravenous VIP. Seven patients (88%) were successfully extubated and were alive at the five day time point. Six (75%) left the hospital and one (13%) died of an unrelated cardiac event. A phase II clinical trial using intravenous Aviptadil in patients with COVID-19 infection and ARDS has begun. Further, a phase II/III clinical trial will study the effect of inhaled Aviptadil for the treatment of non-acute lung injury in COVID- 19 and begins in June 2020. In Europe, two phase II trials of Aviptadil have been conducted. Further, studies with healthy volunteers have shown that inhaled Aviptadil is well tolerated with few adverse effects.
- Conditions
- Covid19, Corona Virus Infection, ARDS, Aviptadil
- Being tested
- Aviptadil 67μg, Placebo 0.9% NaCl solution
- Keywords
- Covid 19, Corona Virus Infection, acute respiratory distress syndrome (ARDS), Aviptadil, Faster recovery
- Medical subject headings
- COVID-19, Coronavirus Infections, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aviptadil 67μgDrug
Participants will receive standard care plus a dose of 67μg nebulized Aviptadil three times a day for ten days.
Placebo 0.9% NaCl solutionDrug
Patiens will receive Standard care plus 0.9% NaCl solution three times a day for ten days
| Study group | Role | What they receive |
|---|---|---|
| Aviptadil Treatment | Experimental | Participants will receive standard care plus a dose of 67μg nebulized Aviptadil three times a day for ten days. Receives: Drug: Aviptadil 67μg |
| Placebo Treatment | Placebo comparator | Participants in the control group will receive an Inhalation of 0.9% NaCl solution three times a day for 10 days Receives: Drug: Placebo 0.9% NaCl solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical improvement
Time to clinical improvement of a decrease of at least two points on a seven-point ordinal scale of clinical status or discharged alive from hospital. The seven-point scale consists of the following categories:
- not hospitalized;
- hospitalized, not requiring supplemental oxygen;
- hospitalized, requiring supplemental oxygen;
- hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both;
- hospitalized, intubation and mechanical ventilation;
- ventilation and additional organ support - pressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO);
- death
Measured: Randomization until discharge from hospital but up to maximum 28 days
Secondary outcomes (10)
Frequency of mechanical ventilation
Frequency of Patient who need mechanical ventilation during hospital stay
Measured: Randomization until discharge from hospital up to maximum 28 days
Oxygen supplementation
Time requiring oxygen supplementation
Measured: Randomization until discharge from hospital up to maximum 28 days
SaO2
Slope in SaO2
Measured: Randomization until discharge from hospital up to maximum 28 days
FiO2
Slope in FiO2
Measured: Randomization until discharge from hospital but up to maximum 28 days
C-reactive Protein
Slope in C-reactive Protein
Measured: measured at baseline, at least every 7 days and at discharge up to maximum 28 days
Neutrophile
Neutrophile ratio
Measured: measured at baseline, at least every 7 days and at discharge up to maximum 28 days
lymphocyte
lymphocyte ratio
Measured: measured at baseline, at least every 7 days and at discharge up to maximum 28 days
Interleukine 6
Interleukine 6 level
Measured: measured at baseline, at least every 7 days and at discharge up to maximum 28 days
Procalcitonin
Procalcitonin level
Measured: measured at baseline, at least every 7 days and at discharge up to maximum 28 days
Frequency of Multi organ dysfunction Syndrome (MODS)
Frequency of Patient who showed a multi organ dysfunction Syndrome during Hospital stay
Measured: Randomization until discharge from hospital up to maximum 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start18 May 2021
- Primary completion14 Jun 2023
- Study completion14 Jun 2023
Why it stopped: Difficulties recruiting participants for the Aviptadil study as there are nowadays very few hospitalized COVID patients. Continuous screening has been carried out but none of the patients met the eligibility criteria for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated to receive either Aviptadil together with standard care or the placebo (NaCl 0.9%) together with standard care,
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Jörg Leuppi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Jörg Leuppi, Cantonal Hospital, Baselland
- Investigators
- Jörg D Leuppi, Professor, Principal investigator, Cantonal Hospital, Baselland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536350
- Sponsor's protocol ID
- 2020-01902
- Status last verified
- Jan 2024
- First submitted
- 21 Aug 2020
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boesing M, Abig K, Brandle M, Brutsche M, Burri E, Frye BC, Giezendanner S, Grutters JC, Haas P, Heisler J, Jaun F, Leuppi-Taegtmeyer AB, Luthi-Corridori G, Muller-Quernheim J, Nuesch R, Pohl W, Rassouli F, Leuppi JD. Inhaled aviptadil for the possible treatment of COVID-19 in patients at high risk for ARDS: study protocol for a randomized, placebo-controlled, and multicenter trial. Trials. 2022 Sep 20;23(1):790. doi: 10.1186/s13063-022-06723-w.
PubMed 36127739
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS: A Randomized, Placebo Controlled, Multicenter Trial
- ClinicalTrials.gov ID
- NCT04536350
- Acronym / sponsor ID
- 2020-01902
- Conditions
- Covid19, Corona Virus Infection, ARDS, Aviptadil
- Keywords
- Covid 19, Corona Virus Infection, acute respiratory distress syndrome (ARDS), Aviptadil, Faster recovery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties recruiting participants for the Aviptadil study as there are nowadays very few hospitalized COVID patients. Continuous screening has been carried out but none of the patients met the eligibility criteria for the study.
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Prof. Dr. Jörg LeuppiUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 2 Sep 2020 (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.
The world is currently experiencing a coronavirus (CoV-2) pandemic. A new (SARS)-CoV infection epidemic began in Wuhan, Hubei, China, in late 2019; originally called 2019- nCoV the virus is now known as SARSCoV- 2 and the disease it causes COVID-19. Previous CoV epidemics included severe acute respiratory syndrome (SARS)-CoV, which started in China in 2003 and Middle East respiratory syndrome (MERS)-CoV in the Middle East, which started in 2012. The mortality rates were >10% for SARS and >35% for MERS. The direct cause of death is generally due to ensuing severe atypical pneumonia and ensuing acute respiratory distress syndrome (ARDS). Pneumonia also is generally the cause of death for people who develop influenza, although the mortality rate is lower (1%-3% for the influenza A H5N1 pandemic of 1918-1919 in the United States). Risk factors for a poor outcome of SARS-CoV-2 infection have so far been found to include older age and co-morbidities including chronic cardiovascular and respiratory conditions and current smoking status. In May 2020, the FDA authorized the emergency use of remdesivir for treatment of COVID-19 disease based on topline date of two clinical trials, even though an underpowered clinical trial did not find significant improvement in COVID- 19 patients treated with remdesivir. Nevertheless, remdesivir is the first and so far, only approved treatment for COVID-19. Additionally further trials and clinical observations have not found a significant benefit of other antiviral drugs. Although the results of several studies are still pending, there is still a desperate need for an effective, safe treatment for COVID-19. Aviptadil, which is a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP), might be beneficial in patients at risk of developing ARDS. Nonclinical studies demonstrate that VIP is highly concentrated in the lung, where it reduces inflammation.
Detailed description
About 20% of individuals with Corona Virus disease (COVID-19) experience more severe disease characterized by significant respiratory symptoms including acute respiratory distress syndrome (ARDS). ARDS is a known lethal complication due to its low blood oxygenation levels and may result in organ failure. Until now, there are no specific vaccines or therapeutic drugs targeting SARS-CoV-2, alternative therapeutic interventions are needed to prevent and ameliorate respiratory conditions associated with COVID-19 to effectively reduce mortality and prevent ICU admissions. Aviptadil, which is a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP), might be beneficial in patients at risk of developing ARDS. Nonclinical studies demonstrate that VIP is highly concentrated in the lung, where it prevents N-methyl-D-aspartate (NMDA)-induced caspase-3 activation, inhibits IL-6 and TNFa production and protects against HCl-induced pulmonary edema. Further, in animal model systems of lung injury in mice, rats, guinea pigs, sheep, swine and dogs, Aviptadil was shown to restore barrier function at the endothelial/alveolar interface and to protect the lung and other organs from failure. In Europe, Aviptadil is approved for human use and has been shown to be safe in phase II trials for sarcoidosis, pulmonary fibrosis, bronchospasm, erectile dysfunction as well as in a phase I trial in ARDS in the past two decades. In the US, VIP has been given FDA Orphan Drug Designation for the treatment of ARDS and was admitted to the FDA Corona Virus Technology Accelerator Program. In a phase I trial of Aviptadil performed by Sami Said in the early 2000s, eight patients with severe ARDS on mechanical ventilation were treated with ascending doses of intravenous VIP. Seven patients (88%) were successfully extubated and were alive at the five day time point. Six (75%) left the hospital and one (13%) died of an unrelated cardiac event. A phase II clinical trial using intravenous Aviptadil in patients with COVID-19 infection and ARDS has begun. Further, a phase II/III clinical trial will study the effect of inhaled Aviptadil for the treatment of non-acute lung injury in COVID- 19 and begins in June 2020. In Europe, two phase II trials of Aviptadil have been conducted. Further, studies with healthy volunteers have shown that inhaled Aviptadil is well tolerated with few adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated to receive either Aviptadil together with standard care or the placebo (NaCl 0.9%) together with standard care,
| Arm | Type | Receives |
|---|---|---|
| Aviptadil Treatment | Experimental | Drug: Aviptadil 67μgParticipants will receive standard care plus a dose of 67μg nebulized Aviptadil three times a day for ten days. |
| Placebo Treatment | Placebo comparator | Drug: Placebo 0.9% NaCl solutionParticipants in the control group will receive an Inhalation of 0.9% NaCl solution three times a day for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- COVID-19 infection diagnosed
- Risk factors for the development of an ARDS according to an adapted EALI (early acute lung injury score) ≥ 2 Points (with at least one point from the EALI score)
- 2-6l O2 supplementation to achieve a SaO2>90%: 1 point
- >6l O2 supplementation to achieve a SaO2>90%: 2 points
- Respiratory rate ≥ 30/min: 1 point
Key exclusion criteria (8 listed)
- Known or highly suspected bacterial infection (antibiotic treatment to avoid bacterial superinfection may be allowed)
- PCT ≥ 1μg/l
- Mechanical ventilation
- Inability to conduct inhalation therapy
- Hemodynamic instability with requirement of vasopressor therapy
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 |
|---|---|---|
| Aviptadil 67μgParticipants will receive standard care plus a dose of 67μg nebulized Aviptadil three times a day for ten days. | Drug | Aviptadil Treatment |
| Placebo 0.9% NaCl solutionPatiens will receive Standard care plus 0.9% NaCl solution three times a day for ten days | Drug | Placebo Treatment |
Primary outcome
Time to clinical improvement
Time frame: Randomization until discharge from hospital but up to maximum 28 days
Time to clinical improvement of a decrease of at least two points on a seven-point ordinal scale of clinical status or discharged alive from hospital. The seven-point scale consists of the following categories: 1. not hospitalized; 2. hospitalized, not requiring supplemental oxygen; 3. hospitalized, requiring supplemental oxygen; 4. hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; 5. hospitalized, intubation and mechanical ventilation; 6. ventilation and additional organ support - pressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO); 7. death
10 secondary outcomes
Frequency of mechanical ventilation
Time frame: Randomization until discharge from hospital up to maximum 28 days
Oxygen supplementation
Time frame: Randomization until discharge from hospital up to maximum 28 days
SaO2
Time frame: Randomization until discharge from hospital up to maximum 28 days
FiO2
Time frame: Randomization until discharge from hospital but up to maximum 28 days
C-reactive Protein
Time frame: measured at baseline, at least every 7 days and at discharge up to maximum 28 days
Neutrophile
Time frame: measured at baseline, at least every 7 days and at discharge up to maximum 28 days
lymphocyte
Time frame: measured at baseline, at least every 7 days and at discharge up to maximum 28 days
Interleukine 6
Time frame: measured at baseline, at least every 7 days and at discharge up to maximum 28 days
Procalcitonin
Time frame: measured at baseline, at least every 7 days and at discharge up to maximum 28 days
Frequency of Multi organ dysfunction Syndrome (MODS)
Time frame: Randomization until discharge from hospital up to maximum 28 days
Results and safety
The study was stopped early (reason given: Difficulties recruiting participants for the Aviptadil study as there are nowadays very few hospitalized COVID patients. Continuous screening has been carried out but none of the patients met the eligibility criteria for the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 36127739Boesing M, Abig K, Brandle M, Brutsche M, Burri E, Frye BC, Giezendanner S, Grutters JC, Haas P, Heisler J, Jaun F, Leuppi-Taegtmeyer AB, Luthi-Corridori G, Muller-Quernheim J, Nuesch R, Pohl W, Rassouli F, Leuppi JD. Inhaled aviptadil for the possible treatment of COVID-19 in patients at high risk for ARDS: study protocol for a randomized, placebo-controlled, and multicenter trial. Trials. 2022 Sep 20;23(1):790. doi: 10.1186/s13063-022-06723-w.
- Individual participant dataSharing planned: No
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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.
Jörg D Leuppi, Professor principal investigator
Cantonal Hospital, Baselland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aviptadil 67μg in people with Covid19 and Corona Virus Infection, run by Prof. Dr. Jörg Leuppi at 2 sites in Switzerland.
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 8 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: stopped early, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Difficulties recruiting participants for the Aviptadil study as there are nowadays very few hospitalized COVID patients. Continuous screening has been carried out but none of the patients met the eligibility criteria for the study.). Results are not available in the source record.
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?
Time to clinical improvement (time frame: Randomization until discharge from hospital but up to maximum 28 days). 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 NCT04536350, which also lists 1 linked publication.
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 18 Jan 2024.