Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS: A Randomized, Placebo Controlled, Multicenter Trial

Who is this study for? Patients with COVID-19 at high risk for ARDS
What treatments are being studied? Aviptadil
Status: Terminated
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

Locations
Other Locations
Switzerland
Cantonal Hospital Baselland Liestal
Liestal
Cantonal Hospital St.Gallen
Sankt Gallen
Time Frame
Start Date: 2021-05-18
Completion Date: 2023-06-14
Participants
Target number of participants: 83
Treatments
Experimental: Aviptadil Treatment
Participants will receive standard care plus a dose of 67μg nebulized Aviptadil three times a day for ten days.
Placebo_comparator: Placebo Treatment
Participants in the control group will receive an Inhalation of 0.9% NaCl solution three times a day for 10 days
Sponsors
Leads: Prof. Dr. Jörg Leuppi

This content was sourced from clinicaltrials.gov

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