Methods of treatment

Abstract

This disclosure features compounds and compositions that are useful in methods of treating coronavirus infections (e.g., useful in methods of treating COVID-19) in a subject in need thereof. The methods include administering to the subject niclosamide compounds (or pharmaceutically acceptable salts and/or co-crystals thereof, e.g., niclosamide). In some embodiments, the niclosamide compounds have one or more properties that include, but are not limited to: a particular purity or a particular particle size. In an aspect, the niclosamide compounds described herein (e.g., niclosamide) can form part of compositions, dosage forms (e.g., unit dosage forms), and the like, which are suitable for respiratory administration (e.g., via inhalation and/or intranasally). In another aspect, the niclosamide compounds described herein (e.g., niclosamide) can form part of compositions, dosage forms (e.g., unit dosage forms), and the like, which are suitable for administration to the GI tract (e.g., orally or rectally such as via enema)).

1 - 20 . (canceled) 
     
     
         21 . A device adapted to administer a dose of a composition to the respiratory system of a subject, the device containing an effective amount of a compound comprising niclosamide: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt, hydrate, or co-crystal thereof to treat a COVID-19 viral infection in a subject in need of such treatment. 
       
     
     
         22 . The device of  claim 21 , wherein the compound comprises niclosamide ethanolamine. 
     
     
         23 . The device of  claim 21 , wherein the composition further comprises one or more pharmaceutically acceptable excipients independently selected from thickeners, viscosity enhancing agents, bulking agents, mucoadhesive agents, penetration enhancers, buffers, preservatives, diluents, binders, lubricants, glidants, disintegrants, fillers, solubilizing agents, pH modifying agents, preservatives, stabilizing agents, anti-oxidants, wetting or emulsifying agents, suspending agents, pigments, colorants, isotonic agents, chelating agents, emulsifiers, and diagnostic agents. 
     
     
         24 . The device of  claim 21 , wherein the composition further comprises:
 a polyvinylpyrrolidone; and   a beta cyclodextrin.   
     
     
         25 . The device of  claim 21 , wherein the composition further comprises sodium salicylate, citric acid, one or more chitosans, one or more phospholipids, one or more fatty acids, one or more fatty acid esters, glycerol, or combinations thereof. 
     
     
         26 . The device of  claim 21 , wherein the device is an inhalation device selected from a nebulizer, a metered dose inhaler, a dry powder inhaler, a jet nebulizer, an ultrasonic wave nebulizer, a heat vaporizer, a soft mist inhaler, a thermal aerosol inhaler, or an electrohydrodynamic-based solution misting inhaler. 
     
     
         27 . The device of  claim 21 , wherein the composition further comprises nanoparticles, spray dried materials, engineered porous particles, liposomes, or combinations thereof. 
     
     
         28 . The device of  claim 21 , wherein the device is a nasal spray. 
     
     
         29 . The device of  claim 21 , containing a prophylactic effective amount of niclosamide. 
     
     
         30 . The device of  claim 21 , wherein the composition has a particle size distribution D(0.9) of from about 1.0 μm to about 10.0 μm