USE OF INHALED NITRIC OXIDE (iNO) FOR TREATMENT OF INFECTION, INCLUDING INFECTION WITH SARS-CoV2 AND TREATMENT OF COVID-19

1 . A method for treating COVID-19 in a patient, the method comprising administering a therapeutically effective amount of inhaled nitric oxide to said patient by:

a) Detecting a breath pattern in said patient including a total inspiratory time;

b) Correlating the breath pattern with an algorithm to calculate the timing of administration of the dose of nitric oxide; and

c) Administering the dose of nitric oxide to said patient in a pulsatile manner over a portion of the total inspiratory time,

wherein the COVID-19 is treated.

2 . A method for treating a viral, bacterial, or protozoal infection leading to development of a disease state in a patient, the method comprising administering a therapeutically effective amount of inhaled nitric oxide to said patient by:

a) Detecting a breath pattern in said patient including a total inspiratory time;

b) Correlating the breath pattern with an algorithm to calculate the timing of administration of the dose of nitric oxide; and

c) Administering the dose of nitric oxide to said patient in a pulsatile manner over a portion of the total inspiratory time,

wherein the viral, bacterial, or protozoal infection is treated.

3 . The method of claim 2 , wherein the viral infection is SARS-CoV2 and the disease state is COVID-19.

4 . A method for inhibiting viral replication of SARS-CoV2 virus in a patient, the method comprising administering a therapeutically effective amount of inhaled nitric oxide to said patient by:

a) Detecting a breath pattern in said patient including a total inspiratory time;

b) Correlating the breath pattern with an algorithm to calculate the timing of administration of the dose of nitric oxide; and

c) Administering the dose of nitric oxide to said patient in a pulsatile manner over a portion of the total inspiratory time,

wherein viral replication of SARS-CoV2 is inhibited.

5 . A method for reducing the need for supplemental oxygen in a patient suffering from a SARS-CoV2 infection or COVID-19, the method comprising administering a therapeutically effective amount of inhaled nitric oxide to said patient by:

a) Detecting a breath pattern in said patient including a total inspiratory time;

b) Correlating the breath pattern with an algorithm to calculate the timing of administration of the dose of nitric oxide; and

c) Administering the dose of nitric oxide to said patient in a pulsatile manner over a portion of the total inspiratory time,

wherein the need for supplemental oxygen is reduced or eliminated.

6 . A method for improving oxygenation of a patient suffering from SARS-CoV2 infection or COVID-19, the method comprising administering a therapeutically effective amount of inhaled nitric oxide to said patient by:

a) Detecting a breath pattern in said patient including a total inspiratory time;

b) Correlating the breath pattern with an algorithm to calculate the timing of administration of the dose of nitric oxide; and

c) Administering the dose of nitric oxide to said patient in a pulsatile manner over a portion of the total inspiratory time,

wherein oxygenation is improved.

7 . A method for improving oxygen saturation of a patient suffering from SARS-CoV2 infection or COVID-19, the method comprising administering a therapeutically effective amount of inhaled nitric oxide to said patient by:

a) Detecting a breath pattern in said patient including a total inspiratory time;

b) Correlating the breath pattern with an algorithm to calculate the timing of administration of the dose of nitric oxide; and

c) Administering the dose of nitric oxide to said patient in a pulsatile manner over a portion of the total inspiratory time,

wherein oxygen saturation is improved.

8 . A method for providing supportive care to a patient in respiratory distress due to COVID-19, the method comprising administering a therapeutically effective amount of inhaled nitric oxide to said patient by:

a) Detecting a breath pattern in said patient including a total inspiratory time;

b) Correlating the breath pattern with an algorithm to calculate the timing of administration of the dose of nitric oxide; and

c) Administering the dose of nitric oxide to said patient in a pulsatile manner over a portion of the total inspiratory time,

wherein the patient's respiratory distress is improved.

9 . A method for reducing the time a patient suffering from SARS-CoV2 infection or COVID-19 is in need of mechanical breathing assistance, the method comprising administering a therapeutically effective amount of inhaled nitric oxide to said patient by:

a) Detecting a breath pattern in said patient including a total inspiratory time;

b) Correlating the breath pattern with an algorithm to calculate the timing of administration of the dose of nitric oxide; and

c) Administering the dose of nitric oxide to said patient in a pulsatile manner over a portion of the total inspiratory time,

wherein the time in need of mechanical breathing assistance is reduced or eliminated.

10 . The method of any of claims 1 - 9 , wherein delivery of the dose of nitric oxide occurs within the first half of the total inspiratory time.

11 . The method of any of claims 1 - 9 , wherein the nitric oxide is delivered in a series of pulses over a period of time.

12 . The method of any of claims 1 - 9 , wherein the inhaled nitric oxide is administered at a dose in a range of about 75 mcg/kg IBW/hr to about 200 mcg/kg IBW/hr.

13 . The method of any of claims 1 - 9 , wherein the inhaled nitric oxide is administered at a dose in a range of about 100 mcg/kg IBW/hr to about 150 mcg/kg IBW/hr.

14 . The method of claim 13 , wherein the inhaled nitric oxide is administered at a dose of about 125 mcg/kg IBW/hr.

15 . The method of any of claims 1 - 14 , wherein the nitric oxide is administered in combination with at least one additional gas.

16 . The method of claim 15 , wherein the at least one additional gas is oxygen.

17 . The method of any of claim 15 or 16 , further comprising the administration of at least one additional therapeutic agent.

18 . The method of claim 17 , wherein administration of the iNO occurs in an outpatient setting.

19 . The method of claims 1 - 14 , wherein the inhaled nitric oxide is administered for at least 24 hours per day over the course of the treatment period.

20 . The method of claim 19 , wherein the inhaled nitric oxide is administered for least 18 hours per day over the course of the treatment period.

21 . The method of claim 20 , wherein the inhaled nitric oxide is administered for least 12 hours per day over the course of the treatment period.

22 . The method of claim 21 , wherein the inhaled nitric oxide is administered for least 8 hours per day over the course of the treatment period.

23 . The method of any of claims 19 - 22 , wherein the treatment period is at least twenty-one days.

24 . The method of claim 23 , wherein the treatment period is at least fourteen days.

25 . The method of claim 24 , wherein the treatment period is at least ten days.

26 . The method of claim 25 , wherein the treatment period is at least seven days.

27 . The method of claim 26 , wherein the treatment period is at least five days.

28 . A method for delivery of a dose of nitric oxide to a patient in need, said method comprising:

a) Detecting a breath pattern in said patient including a total inspiratory time using a device comprising a breath sensitivity control;

b) Correlating the breath pattern with an algorithm to calculate the timing of administration of the dose of nitric oxide, wherein the dose is from about 500 mcg/kg IBW/hr to about 1200 mcg/kg IBW/hr; and

c) Delivering the dose of nitric oxide to said patient in a pulsatile manner over a portion of the total inspiratory time.

29 . The method of claim 28 , wherein the dose is from about 500 mcg/kg IBW/hr to about 1000 mcg/kg/IBW.

30 . The method of claim 28 , wherein the dose is 1000 mcg/kg IBW/hr.

31 . The method of claim 28 , wherein the dose is 1050 mcg/kg IBW/hr.

32 . The method of any of claims 28 - 31 , wherein the dose of iNO is delivered twice a day.

33 . The method of any of claims 28 - 31 , wherein the dose of iNO is delivered three times a day.

34 . The method of any of claims 28 - 31 , wherein the dose of iNO is delivered four times a day.

35 . The method of any of claims 28 - 31 , wherein the dose of iNO is delivered five times a day.

36 . The method of any of claims 28 - 31 , wherein the dose of iNO is delivered two to four times a day.

37 . The method of any of claims 32 - 36 , wherein the dose of iNO is administered for at least 15 minutes per day over the course of the treatment period.

38 . The method of any of claims 32 - 36 , wherein the dose of iNO is administered for at least 30 minutes per day over the course of the treatment period.

39 . The method of any of claims 32 - 36 , wherein the dose of iNO is administered for at least 45 minutes per day over the course of the treatment period.

40 . The method of any of claims 32 - 36 , wherein the dose of iNO is administered for at least one hour per day over the course of the treatment period.

41 . The method of any of claims 32 - 36 , wherein the dose of iNO is administered for at least 1.5 minutes per day over the course of the treatment period.

42 . The method of any of claims 32 - 36 , wherein the dose of iNO is administered for at least two hours per day over the course of the treatment period.

43 . The method of any of claims 32 - 36 , wherein the dose of iNO is administered for between one to two hours per day over the course of the treatment period.

44 . The method of any of claims 37 - 43 , wherein the treatment period is from about one day to about seven days.