Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04536350
Status:
TERMINATED
Last Update Posted:
2024-01-18
First Post:
2020-08-21
Brief Title:
Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS
Sponsor:
Prof Dr Jörg Leuppi
Organization:
Cantonal Hosptal Baselland
Study Overview
Official Title:
Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS A Randomized Placebo Controlled Multicenter Trial
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 endothelialalveolar 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 IIIII 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None