Covid19 Clinical Trial
Official title:
A Phase 3, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Polio Vaccine and NA-831 for Prophylaxis and Treatment of Early Onset of Covid-19
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.
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