ACTIVATING ENDOGENOUS ANTIMICROBIALS TO TREAT SARS-COV-2 INFECTION
Provided herein are methods of treating COVID-19 in a subject in need thereof, comprising administering to the subject a 25-hydroxyvitamin D compound. Also provided herein are hard capsule dosage forms of 25-hydroxyvitamin. In aspects, the 25-hydroxyvitamin D is administered as a controlled release formulation, optionally an extended release oral formulation, such as Rayaldee® extended release calcifediol capsules. Methods of treating SARS-CoV-2 infection including reducing SARS-CoV-2 viral load are provided. Methods of treating SARS-CoV-2 infection including increasing an immune response are provided.
1 .- 163 . (canceled)
164 . A method of treating a SARS-CoV-2 infection, comprising administering to a subject in need thereof an effective amount of a 25-hydroxyvitamin D compound to treat the SARS-CoV-2 infection.
165 . The method of claim 164 , comprising administering the 25-hydroxyvitamin D compound in a controlled release formulation.
166 . The method of claim 165 , wherein the controlled release formulation comprises a sustained release formulation.
167 . The method of claim 164 , wherein the 25-hydroxyvitamin D compound comprises 25-hydroxyvitamin D 3 or consists of 25-hydroxyvitamin D 3 .
168 . The method of claim 164 , wherein the subject has Chronic Kidney Disease Stage 3 or 4 and secondary hyperparathyroidism.
169 . The method of claim 164 , comprising administering to the subject in need thereof an effective amount of the 25-hydroxyvitamin D compound to increase the subject's serum total 25-hydroxyvitamin D level to at least 50 ng/ml, or greater than 50 ng/ml.
170 . The method of claim 169 , comprising administering to the subject in need thereof an effective amount of the 25-hydroxyvitamin D compound to increase the subject's serum total 25-hydroxyvitamin D level to at least 60 ng/ml.
171 . The method of claim 169 , comprising administering to the subject in need thereof an effective amount of the 25-hydroxyvitamin D compound to increase the subject's serum total 25-hydroxyvitamin D level to in a range of 50 ng/ml to 200 ng/ml.
172 . The method of claim 164 , comprising administering to the subject a loading dose of the 25-hydroxyvitamin D compound followed by one or more maintenance doses of the 25-hydroxyvitamin D compound.
173 . The method of claim 172 , wherein the loading dose is in a range of about 500 μg to about 1200 μg of the 25-hydroxyvitamin D compound.
174 . The method of claim 172 , wherein the loading dose is administered in divided doses over a period of 2 to 5 days.
175 . The method of claim 174 , wherein the loading dose is administered in divided doses over 3 days.
176 . The method of claim 173 , wherein the loading dose is 900 μg of the 25-hydroxyvitamin D compound.
177 . The method of claim 176 , wherein the loading dose is administered in divided doses over 3 days.
178 . The method of claim 172 , wherein the maintenance dose is in a range of about 50 μg to about 100 μg of the 25-hydroxyvitamin D compound.
179 . The method of claim 178 , wherein the maintenance dose is about 60 μg of the 25-hydroxyvitamin D compound per day.
180 . The method of claim 172 , wherein the loading dose is in a range of about 125 μg to about 300 μg bioavailable amount of 25-hydroxyvitamin D, and is administered in the fasting state.
181 . The method of claim 180 , wherein the loading dose is about 225 μg bioavailable amount of 25-hydroxyvitamin D, and is administered in the fasting state.
182 . The method of claim 172 , wherein the maintenance dose is in a range of about 6 μg to about 25 μg bioavailable amount of 25-hydroxyvitamin D per day, and is administered in the fasting state.
183 . The method of claim 182 , wherein the maintenance dose is about 15 μg bioavailable amount of 25-hydroxyvitamin D per day, and is administered in the fasting state.
184 . The method of claim 172 , comprising administering daily maintenance doses for at least 13 days.
185 . The method of claim 164 , comprising administering the 25-hydroxyvitamin D in the fasting state.
186 . The method of claim 164 , comprising administering the 25-hydroxyvitamin D orally.
187 . The method of claim 164 , wherein the subject has Coronavirus Disease 2019 (COVID-19).
188 . The method of claim 164 , wherein the subject's baseline serum total 25-hydroxyvitamin D level is less than 30 ng/mL.
189 . The method of claim 164 , wherein the subject's baseline serum total 25-hydroxyvitamin D level is at least 30 ng/mL.
190 . A method of treating COVID-19 disease, comprising administering to a subject having COVID-19 an effective amount of an oral, sustained release formulation comprising 25-hydroxyvitamin D 3 to improve the subject's COVID-19 symptoms.
191 . The method of claim 190 , wherein the administering accelerates the subject's return to normal activities and/or accelerates the subject's return to normal health.
192 . A method of treating COVID-19 disease, comprising administering to a subject having COVID-19 an oral, sustained release formulation comprising 25-hydroxyvitamin D 3 in a loading dose in a range of about 500 μg to 1200 μg 25-hydroxyvitamin D 3 administered in divided doses over multiple days, followed by at least two maintenance doses of the sustained release formulation comprising 25-hydroxyvitamin D 3 in a range of about 50 μg to about 100 μg per day.
193 . A method of treating COVID-19 disease, comprising administering to a subject having COVID-19 an oral formulation comprising 25-hydroxyvitamin D 3 in a loading dose in a range of about 125 μg to about 300 μg bioavailable amount of 25-hydroxyvitamin D 3 administered in divided doses over multiple days, followed by at least two maintenance doses of the formulation in a range of about 6 μg to about 25 μg bioavailable amount of 25-hydroxyvitamin D 3 per day.