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Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS

NCT04536350 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2024-01-18

No results posted yet for this study

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.

Conditions

  • Covid19
  • Corona Virus Infection
  • ARDS
  • Aviptadil

Interventions

DRUG

Aviptadil 67μg

Participants will receive standard care plus a dose of 67μg nebulized Aviptadil three times a day for ten days.

DRUG

Placebo 0.9% NaCl solution

Patiens will receive Standard care plus 0.9% NaCl solution three times a day for ten days

Sponsors & Collaborators

  • Prof. Dr. Jörg Leuppi

    lead OTHER

Principal Investigators

  • Jörg D Leuppi, Professor · Cantonal Hosptal, Baselland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2023-06-14
Completion
2023-06-14

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04536350 on ClinicalTrials.gov