Trial · Interventional
TerminatedPhase 2Registry dataThis trial was stopped early.
Reason given at the registry: 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.
Switzerland
1 trial · 1 stopped early
Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS
NCT0453635018 May 2021 to 14 Jun 2023
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
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
Outcomes the sponsor listed as primary.
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
Frequency of mechanical ventilation
Time frame · Randomization until discharge from hospital up to maximum 28 days
Frequency of Patient who need mechanical ventilation during hospital stay
Oxygen supplementation
Time frame · Randomization until discharge from hospital up to maximum 28 days
Time requiring oxygen supplementation
SaO2
Time frame · Randomization until discharge from hospital up to maximum 28 days
Slope in SaO2
FiO2
Time frame · Randomization until discharge from hospital but up to maximum 28 days
Slope in FiO2
C-reactive Protein
Time frame · measured at baseline, at least every 7 days and at discharge up to maximum 28 days
Slope in C-reactive Protein
Neutrophile
Time frame · measured at baseline, at least every 7 days and at discharge up to maximum 28 days
Neutrophile ratio
lymphocyte
Time frame · measured at baseline, at least every 7 days and at discharge up to maximum 28 days
lymphocyte ratio
Interleukine 6
Time frame · measured at baseline, at least every 7 days and at discharge up to maximum 28 days
Interleukine 6 level
Procalcitonin
Time frame · measured at baseline, at least every 7 days and at discharge up to maximum 28 days
Procalcitonin level
Frequency of Multi organ dysfunction Syndrome (MODS)
Time frame · Randomization until discharge from hospital up to maximum 28 days
Frequency of Patient who showed a multi organ dysfunction Syndrome during Hospital stay
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
0 studies on this page
Indexing hint: Clinical trial · 2022
Boesing et al. 2022Trialscited by 3
PMID 36127739PMC9486780DOI 10.1186/s13063-022-06723-wPUB-36127739
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated