This is a double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating Nitric Oxide Nasal Irrigation (NONI) for the treatment of COVID-19 in individuals with mild COVID-19 Infection.
Up to 50 subjects will be enrolled into one of two cohorts of this study in a ratio of 1:1 (Treatment: Placebo Control). Subjects will be screened and randomized into one of two parallel cohorts. * Treatment (N = up to 25): Subjects will be enrolled and receive daily NONI treatment for 14 days with a follow-up visit on Day 28 post randomization. * Placebo (N = up to 25): Subjects will be enrolled and receive a placebo for 14 days with a follow-up visit on Day 28 post randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Nasal Spray + Nasal Irrigation
To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity
Measure the SARS-CoV-2 viral load (Cycle threshold) at baseline through Day 6 between NONI and control arms.
Time frame: 6 Days
To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection
Measure the proportion of subjects reaching Ct threshold (ie: unmeasurable viral load) between NONI and control
Time frame: 2, 4 and 6 days
To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection
Measure the difference in time-to Ct threshold (ie: unmeasurable viral load) between NONI and control.
Time frame: 2, 4 and 6 days
To Measure the efficacy of NONI in prevention of progression of COVID-19
Measure the proportion of subjects requiring hospitalization or ER/ED visits for COVID-19/flu-like symptoms
Time frame: 28 days
To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life (QoL) in subjects with COVID-19
Measure the difference in 12-point COVID Symptom PROs score 0-3 (min 0 \& max 36) and a QoL score from 0-100 (lower is worse) from baseline between NONI and control arms.
Time frame: 6 days
To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19
Measure the difference in proportion of subjects experiencing a reduction of ≥ 5 from baseline between NONI and control arms.
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Time frame: 2, 4, 6, 14 and 28 days
To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19
Measure the difference in proportion of subjects with reduction to a score of zero from baseline between NONI and control arms.
Time frame: 2, 4, 6, 14 and 28 days
To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection
Number of participants lost-to-follow-up,discontinuing study treatment or number of treatments due to intolerance
Time frame: 14 days
To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection
Severity and frequency of adverse events, pain, discomfort or discontinuations of treatment.
Time frame: 14 days