NCT04442230

NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Altimmune, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 1:1 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.

Conditions

• Coronavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	NasoVAX	NasoVAX consists of replication-deficient adenovirus vectors in suspension
OTHER	Placebo	Normal saline

Timeline

• Start date: 2020-10-10
• Primary completion: 2021-02-15
• Completion: 2021-02-15
• First posted: 2020-06-22
• Last updated: 2022-04-04
• Results posted: 2022-04-04

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study