T-COVID - Single-Dose Intranasal Therapeutic for the Treatment of Early Covid-19

Experimental design
Day -2 or Day -22

• Intranasal administration (2.5 x108ifu) of either empty vector (vector without antigen) or NasoVAX (vector with antigen)

Day 0

• Challenge with influenza A/CA/04/2009 (3 x LD50)

Results

• Protection provided by both empty vector and NasoVAX
• Protection occurred when treated between 2-and 22-days prior to challenge
• Identical results obtained following challenge with other influenza A strains, influenza B, H5N1 and H7N9

• Intranasal administration of either empty vector or NasoVAX on Day -2
• Challenge with influenza A/PR/08/34 (4 x LD50) on Day 0
• Lung histology on Day +19 post-challenge

Balb/c mice administered an intranasal dose of RD-Ad5 (3.2 x 108ifu) on Day -2 and challenged with influenza A/CA/04/2009 (3 x LD50) on Day 0. Cytokines in lung lavage were analyzed on Days 3 and 6; mean ±SD, p ≤ 0.05, **p ≤ 0.01 by ANOVA

Indications:

• Prevention of clinical worsening and hospitalization of ambulatory patients with early COVID-19
• Prevention of COVID-19 in individuals at high-risk of infection (known exposures)
• Potential first-line community protection against future strains of coronavirus and other pandemics

Mode of administration: Single dose, intranasal, with potential for self-administration
Storage and distribution: Stable at ambient temperatures for 3 or more months
Safety profile: Similar to placebo

• 96 community-based patients with fever, cough, or shortness of breath, with onset of symptoms within 48 hours, and a diagnosis of COVID-19 within 24 hours, will be randomized 1:1 to NasoVAX or placebo administered as a single 0.5 mL nasal spray on the day of diagnosis
• The study will consist of 3 cohorts of increasing age and risk for complications of COVID-19
• Primary efficacy endpoint
• Proportion of patients with clinical worsening, defined as a 4% decrease in pulse oxygen saturation (SpO2), or hospitalization
• Secondary endpoints
• Average decrease in resting SpO2
• Average increase in resting pulse rate
• Proportion of patients requiring oxygen supplementation and mechanical ventilation
• FDA agreed to allow Altimmune use its existing lot of RD-Ad5-based NasoVAX influenza vaccine for this trial so that it may be initiated quickly