DAS181 for COVID-19
Sponsored by Ansun Biopharma
This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection.
It also contains a sub-study to enroll patients with severe COVID-19.
About COVID-19
Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.
How is this study designed?
Study Type: Interventional (Clinical Trial) Estimated Enrollment: 250 participants Primary Purpose: Treatment Actual Study Start Date: May 23, 2019 Estimated Study Completion Date: December 28, 2021
Who is this study for?
For COVID-19 sub study*:
- Be ≥18 years of age
- Provide adequate medical history to permit accurate stratification (but health status may be healthy, high-risk conditions, or immunocompromised).
- Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of daily living (basic ADL)
- Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without contrast, to involve at least 2 lobes of the lung.
- Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by at least one of the following samples
* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
What should I expect?
Arm 1 Drug: DAS181 DAS181 4.5mg nebulized qd x 7 OR 10 days
Arm 2 Drug: Placebo Placebo nebulized qd x 7 OR 10 days
Arm 3 Drug: DAS181 OL DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days < 40kg
Arm 4 Drug: DAS181 COVID-19 DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
Have questions or need help?
For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you'll be connected to the team.