Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
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.