Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04442230
Status:
TERMINATED
Last Update Posted:
2022-04-04
First Post:
2020-06-17
Brief Title:
NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 COVID-19
Sponsor:
Altimmune Inc
Organization:
Altimmune Inc
Study Overview
Official Title:
Phase 2 Double-blind Randomized Placebo-controlled Study of NasoVAX in the Prevention of Clinical Worsening in Patients With Early Coronavirus Infectious Disease 2019 COVID-19
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of NasoVAX in preventing worsening of symptoms and hospitalization in patients with early COVID-19
Detailed Description:
After being informed about the study and potential risks all patient volunteers that have given written informed consent will undergo screening to determine eligibility for study entry If the patient qualifies for the study they will be randomized in a double-blind manner in a 11 ratio to receive NasoVAX or placebo On the same day of qualifying into the study the patient will be administered the investigational drug either NasoVAX or placebo
The patient will return home for the remainder of the study During this period the patient will be monitored remotely by the study center for clinical status The patient will also be contacted by study center personnel by telephone to ask about use of any medications and changes in health including information about any hospitalization
The patient will return home for the remainder of the study During this period the patient will be monitored remotely by the study center for clinical status The patient will also be contacted by study center personnel by telephone to ask about use of any medications and changes in health including information about any hospitalization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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