This is a Phase 2, randomized, double-blind, placebo-controlled study of INNA-051 in adults following household contact with an individual with RT-PCR confirmed SARS CoV-2 infection. This study will evaluate 2 active dose levels of INNA-051 and placebo.
Adults who have a household member with RT-PCR-confirmed SARS-CoV-2 infection and have been in close contact, and who test negative to SARS-CoV-2, will be randomized. Participants will receive 4 doses of study medication over a 10 day period, and complete symptoms scores and questionnaires. Development of COVID-19 symptoms will require collection of a nasal swab for RT-PCR testing. Telephone visits will occur on Days 2, 4, 10, 21, 28, and 35. Additional visits will occur on Days 7, 14, and 42 (end of study).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Evaluate the ability of INNA-051 to reduce the incidence of symptomatic RT-PCR confirmed SARS-CoV-2 infection
Incidence of symptomatic RT PCR confirmed SARS CoV 2 infection
Time frame: To Day 14
Evaluate the safety and tolerability of INNA 051.
Treatment emergent adverse events
Time frame: To Day 42
Evaluate the ability of INNA 051 to reduce the severity of symptoms in adults who develop RT PCR confirmed SARS CoV-2 infection after randomization
Incidences of RT PCR confirmed moderate or severe SARS-CoV-2 infection, or COVID 19 related death
Time frame: To Day 14 and to Day 28
Evaluate the ability of INNA 051 to reduce the severity of symptoms in adults who develop RT PCR confirmed SARS CoV-2 infection after randomization
Incidences of RT-PCR confirmed severe SARS-CoV-2 infection, or COVID-19-related death
Time frame: To Day 14 and to Day 28
Evaluate the ability of INNA 051 to reduce the severity of symptoms in adults who develop RT PCR confirmed SARS CoV-2 infection after randomization
Modified FLU-PRO© total scores
Time frame: On Day 14 and Day 28
Evaluate the ability of INNA 051 to reduce the severity of symptoms in adults who develop RT PCR confirmed SARS CoV-2 infection after randomization
Modified FLU-PRO subscale scores for symptom severity by body system (nose, throat, eyes, chest/respiratory and gastrointestinal) in participants with RT PCR confirmed SARS CoV-2 infection
Time frame: On Day 14 and Day 28
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Evaluate the ability of INNA 051 to reduce the incidence of RT PCR confirmed SARS CoV-2 infection
Incidence of symptomatic RT-PCR-confirmed SARS CoV-2 infection confirmed SARS CoV-2 infection
Time frame: To Day 28
Evaluate the ability of INNA 051 to reduce the incidence of RT PCR confirmed SARS CoV-2 infection
Incidence of RT PCR confirmed SARS CoV-2 infection, through Day 14 and Day 28
Time frame: To Day 14 and to Day 28
Evaluate the ability of INNA 051 to reduce COVID 19 related healthcare utilization
Incidences of COVID 19 related emergency room visits, hospitalizations, or COVID 19 related death among participants with RT PCR confirmed SARS CoV-2 infection
Time frame: To Day 14 and to Day 28
Evaluate the ability of INNA 051 to reduce COVID 19 related healthcare utilization
2\. Incidences of COVID 19 related medically attended visits (telemedicine, physician office, urgent care center, emergency room, hospitalization) or COVID 19 related death among participants with RT PCR-confirmed SARS CoV-2 infection
Time frame: To Day 14 and to Day 28