In this randomized double blind Phase 3 clinical trial we will study the efficacy and safety of oral polio vaccine with and without NA-831 versus placebo.
Early clinical studies showed that besides protecting against poliomyelitis, oral polio vaccine (OPV) reduced the number of other viruses that could be isolated from immunized children, compared with placebo recipients. Both poliovirus and coronavirus are positive-strand RNA viruses; therefore, it is likely that they may induce and be affected by common innate immunity mechanisms. Recent reports indicate that COVID-19 may result in suppressed innate immune responses. Stimulation by live attenuated oral polio vaccines could increase resistance to infection by the causal virus, severe acute respiratory syndrome-SARS-CoV-2. It has been discovered that SARS-CoV-2 viruses (Covid-19) can directly invade the nervous system of patients, instead of injuring the nervous system through the immune response. Increasing evidence suggests that infection with SARS-CoV-2 causes neurological deficits in a substantial proportion of affected patients. It was observed that patients surviving COVID-19 are at high risk for subsequent development of neurological disease and in particular Alzheimer's disease. NA-831 is a new neuroprotective and neurogenesis drug that has been demonstrated its promising safety and efficacy in Phase 2A for the treatment of early onset ofAlzheimer's disease. NA-831 in oral formulation is well tolerated NA-831 with no adverse effects. The Phase 3 clinical trial will evaluate the safety and efficacy of OPV with and without NA-831 versus placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,600
Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump
Placebo of a vaccine 0.1 ml administered orally on a sugar lump
Drug: NA-831 30 mg of NA-831 in a capsule administered orally
Coronavirus Research Institute- Testing Site
Los Angeles, California, United States
Coronavirus Research Institute
Orange, California, United States
Coronavirus Research Institute-Testing Site
Palo Alto, California, United States
Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of OPV with or without NA-831
Number of participants infected with Covid-19 after second dose
Time frame: Time Frame: Day 29 (second dose) up to Day 365 (1 years after second dose)
Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal
Number of participants with adverse events
Time frame: Time Frame: Up to Day 365 (1 years after second dose)
Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of OPV with or without NA-831
Clinical signs indicative of severe COVID-19 as predefined for the study.
Time frame: Time Frame: Day 29 (second dose) up to Day 365 (1 years after second dose)
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
Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.
Time frame: Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose)
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Placebo 30 mg in a capsule administered orally
Combination of biological: Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump and drug NA-831 30 mg in a capsule administered orally
Combination of biological placebo 0.1 ml administered orally on a sugar lump and drug placebo 30 mg in a capsule administered orally
Coronavirus Research Testing Site
San Francisco, California, United States
Coronavirus Research Institute-Testing Site
Sunnyvale, California, United States
Coronavirus Research Institute
Sunnyvale, California, United States
Coronavirus Research Institute-Testing Site
Naperville, Illinois, United States
Coronavirus Research Institute-Testing Site-
The Bronx, New York, United States
NeuroActiva-Clinical Research Unit
Auckland, New Zealand
NeuroActiva Testing Facility of NeuroActiva (New Zealand) Ltd
Auckland, New Zealand