NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04442230|
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infection||Biological: NasoVAX Other: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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)|
|Estimated Study Start Date :||September 29, 2020|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).
NasoVAX consists of replication-deficient adenovirus vectors in suspension
Placebo Comparator: Placebo
Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).
- Proportion of patients with clinical worsening [ Time Frame: Day 1 to Day 14 ]Decrease from baseline in mean resting SpO2
- Maximal severity of COVID-19 after treatment [ Time Frame: Day 1 to Day 42 ]Proportion of patients requiring hospitalization
- All-cause mortality [ Time Frame: Day 1 to Day 42 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442230
|Contact: Christine Orlando||(240) email@example.com|
|Contact: Staci Steelefirstname.lastname@example.org|
|United States, Florida|
|Miami Dade Medical Research Institute||Recruiting|
|Miami, Florida, United States, 33176|
|United States, Louisiana|
|Metairie, Louisiana, United States, 70006|
|United States, Texas|
|McAllen, Texas, United States, 78504|