T-COVID - Single-Dose Intranasal Therapeutic for the Treatment of Early Covid-19
Identical vector technology used for AdCOVID (COVID-19), NasoVAX (seasonal influenza) and NasoShield (anthrax) vaccines.
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T-COVIDTM: MODULATES INNATE IMMUNITY IN ANIMAL MODELS
Data from 6 preclinical studies of influenza infection funded by NIAID and conducted at Utah State University showed:
- Rapid, non-antigen mediatedmodification of host cytokine response
- Protection from lethal challengeoccurs within days and lasts for weeks
- Significantly decreased inflammationfollowing respiratory virus infection
PROTECTION ESTABLISHED IN ANIMALS WITHIN 2 DAYS
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 o...
- 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-...
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
TARGET PRODUCT PROFILE
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
PHASE 1/2 CLINICAL TRIAL DESIGN
- 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
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