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NA-831 for Coronavirus (OPV-NA831 Trial)

Phase 3

Waitlist Available

Research Sponsored by NeuroActiva, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame: day 29 (second dose) up to day 365 (1 years after second dose)

Awards & highlights

OPV-NA831 Trial Summary

This trial will study if oral polio vaccine is effective and safe when given with and without NA-831, compared to placebo.

Eligible Conditions

Coronavirus
SARS
COVID-19

OPV-NA831 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: day 29 (second dose) up to day 365 (1 years after second dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: day 29 (second dose) up to day 365 (1 years after second dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: day 29 (second dose) up to day 365 (1 years after second dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal

Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of OPV with or without NA-831

Secondary outcome measures

Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of OPV with or without NA-831 or Placebo regardless of evidence of prior SARS-CoV-2 Infection

Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of OPV with or without NA-831

OPV-NA831 Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Standard dose of bivalent OPV and NA-831Experimental Treatment1 Intervention

Biological: oral polio vaccine Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump Plus 30 mg of neuroprotection drug NA-831 in a capsule administered orally

Group II: Standard dose of NA-831Experimental Treatment1 Intervention

Drug: neuroprotection NA-831 30 mg of NA-831in a capsule administered orally

Group III: Standard dose bivalent oral polio vaccineExperimental Treatment1 Intervention

Biological: oral polio vaccine Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump

Group IV: Comparable PlaceboPlacebo Group1 Intervention

Placebo of a vaccine administered orally on a sugar lump Plus 30 mg of a placebo in a capsule administered orally

Group V: Comparable Placebo- 0.10 mg/kgPlacebo Group1 Intervention

Saline administered orally on a sugar lump

Group VI: Comparable Placebo- 30mgPlacebo Group1 Intervention

30 mg of placebo in a capsule administered orally

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Biomed Industries, Inc.Industry Sponsor

1 Previous Clinical Trials

525 Total Patients Enrolled

NeuroActiva, Inc.Lead Sponsor

3 Previous Clinical Trials

696 Total Patients Enrolled

Lloyd Tran, PhDStudy DirectorCoronavirus Research Institute

3 Previous Clinical Trials

696 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the potential harmful effects of NA-831?

"There is both pre-existing data supporting the efficacy of NA-831 and data from multiple rounds of testing that point to its safety. Consequently, our team has given it a score of 3."

Answered by AI

Are people currently signing up to be a part of this experiment?

"According to clinicaltrials.gov, this trial is not enrolling patients at the moment. The trial was first posted on November 1st, 2020 and was last updated on September 5th, 2020. Although this trial is not enrolling candidates anymore, there are 1166 other studies actively recruiting participants at this time."

Answered by AI

Are there any other published papers on NA-831's effects?

"There are currently 3 active clinical trials for NA-831, with 1 study in Phase 3. While most of the research is based in Burlington, Vermont, there are a total of 16 research sites for NA-831."

Answered by AI

How many people are entering this clinical trial?

"Presently, this trial is not looking for more patients. It was originally posted on November 1st, 2020 and updated on September 5th, 2020. There are currently 1163 clinical trials for severe acute respiratory syndrome (sars) and 3 trials for NA-831 that are actively recruiting participants."

Answered by AI

Have there been any similar trials like this one in the past?

"3 ongoing studies for NA-831 are being conducted in 11 cities and 4 countries. The first study, sponsored by NeuroActiva, Inc., was completed in 2020 and involved 3600 patients. 22 studies have been conducted in total since 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 3 Randomized Double Blind Efficacy and Safety Study of Oral Polio Vaccine and NA-831 for Covid-19

2020. "A Phase 3 Randomized Double Blind Efficacy and Safety Study of Oral Polio Vaccine and NA-831 for Covid-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04540185.

All > Polio