Cohort 6: NDV-HXP-S high dose IM for COVID-19

Icahn School of Medicine at Mount Sinai, New York, NY
COVID-19NDV-HXP-S IM high dose - Biological
Eligibility
18 - 59
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new vaccine for COVID-19 that is given either in the nose or in the arm. The vaccine is made from a live virus that has been modified to express the spike protein of SARS-CoV-2. The trial will compare two different doses of the vaccine and will also test a placebo vaccine.

Eligible Conditions
  • COVID-19

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 365 days

14 days
Number of local and systemic reactions
365 days
Number of adverse events (AEs)
Number of medically-attended adverse events (MAAEs)
Number of serious adverse events (SAEs)

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

7 Treatment Groups

Cohort 6: NDV-HXP-S high dose IM
1 of 7
Cohort 2: NDV-HXP-S low dose IN
1 of 7
Cohort 3: NDV-HXP-S low dose IM
1 of 7
Cohort 4: NDV-HXP-S low dose IN+IM in combination
1 of 7
Cohort 5: NDV-HXP-S high dose IN
1 of 7
Cohort 7: NDV-HXP-S high dose IN+IM in combination
1 of 7
Cohort 1: Placebo / Sodium Chloride
1 of 7

Active Control

Non-Treatment Group

35 Total Participants · 7 Treatment Groups

Primary Treatment: Cohort 6: NDV-HXP-S high dose IM · Has Placebo Group · Phase 1

Cohort 1: Placebo / Sodium Chloride
Drug
PlaceboComparator Group · 1 Intervention: Sodium Chloride · Intervention Types: Drug
Cohort 6: NDV-HXP-S high dose IM
Biological
ActiveComparator Group · 1 Intervention: NDV-HXP-S IM high dose · Intervention Types: Biological
Cohort 2: NDV-HXP-S low dose IN
Biological
ActiveComparator Group · 1 Intervention: NDV-HXP-S IN low dose · Intervention Types: Biological
Cohort 3: NDV-HXP-S low dose IM
Biological
ActiveComparator Group · 1 Intervention: NDV-HXP-S IM low dose · Intervention Types: Biological
Cohort 4: NDV-HXP-S low dose IN+IM in combinationActiveComparator Group · 2 Interventions: NDV-HXP-S IN low dose, NDV-HXP-S IM low dose · Intervention Types: Biological, Biological
Cohort 5: NDV-HXP-S high dose IN
Biological
ActiveComparator Group · 1 Intervention: NDV-HXP-S IN high dose · Intervention Types: Biological
Cohort 7: NDV-HXP-S high dose IN+IM in combinationActiveComparator Group · 2 Interventions: NDV-HXP-S IM high dose, NDV-HXP-S IN high dose · Intervention Types: Biological, Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 365 days

Who is running the clinical trial?

Sean LiuLead Sponsor
Sean Liu, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Eligibility Criteria

Age 18 - 59 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

How many volunteers are partaking in this clinical trial?

"Confirmed. The information hosted on clinicaltrials.gov reveals that recruitment for this medical trial is still underway, having been initiated February 1st 2022 and most recently updated June 30th 2022. 35 participants are needed at a single site to complete the study." - Anonymous Online Contributor

Unverified Answer

Is the research team recruiting patients for participation in this trial?

"According to clinicaltrials.gov, this investigation is still recruiting participants for their trial which was posted on February 1st 2022 and last amended on June 30th of the same year." - Anonymous Online Contributor

Unverified Answer

How perilous is the administration of high doses of NDV-HXP-S via intramuscular injection for individuals?

"Power's safety assessment of Cohort 6: NDV-HXP-S high dose IM is a 1, due to limited clinical evidence regarding its efficacy and security." - Anonymous Online Contributor

Unverified Answer

Who has the capability to participate in this experiment?

"This experimental trial is searching for 35 individuals diagnosed with Newcastle Disease between the ages of 19 and 59. Before enrolment, applicants must meet a variety of criteria such as providing written consent, being neither pregnant nor trying to conceive, testing negative on an RT-PCR test and SARS-CoV-2 nucleocapsid antibody test at screening, agreeing not to participate in another clinical study related to COVID until day 365 post intervention and granting permission for medical records release. In addition, male participants are asked to use condoms during sexual activity where ejaculate can be passed onto others while WOCBP partners may take advantage of additional highly" - Anonymous Online Contributor

Unverified Answer

Are individuals of a younger age bracket eligible to partake in this research?

"The ages of the patients selected for this medical trial must be between 19 and 59 years old." - Anonymous Online Contributor

Unverified Answer

What is the traditional function of Cohort 6: NDV-HXP-S high dose IM?

"Cohort 6: NDV-HXP-S high dose IM is a popular remedy for diarrhea, as well as inflammation of the nasal mucosa and corneal edema. It can be used in general surgery applications too." - Anonymous Online Contributor

Unverified Answer

Does the research literature contain any other studies related to Cohort 6: NDV-HXP-S high dose IM?

"Currently, there are 100 live experiments researching Cohort 6: NDV-HXP-S high dose IM with 25 trials in the Phase 3 stage. The concentration of these studies is predominantly found in Philadelphia, Pennsylvania; however 385 medical centres across the globe have conducted research on Cohort 6: NDV-HXP-S high dose IM." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.