Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

If this isn't seriously ill, what is?

From your post:

"Inclusion criteria...

Currently hospitalized and requiring medical care for COVID-19.

Moderate OR severe COVID-19, defined by respiratory function at screening, as below:

Moderate, meets at least one of the following criteria:
Peripheral oxygen saturation SpO2 > 93% on room air;
Respiratory rate ≥ 20 to < 30 breaths per minute.

Severe, meets at least one of the following criteria:
Peripheral oxygen saturation SpO2 ≤ 93% on room air OR arterial oxygen partial pressure (PaO2) / fraction of inspired oxygen (FiO2) < 300mmHg (1mmHg=0.133kPa) [corrective formulation should be used for higher altitude regions (over 1000m)];
Respiratory rate ≥ 30 breaths per minute"

...most were older with significant comorbities."

Patients with mild to moderate renal and hepatic disease were allowed in the trial even though they are at risk of becoming worse with Covid 19.

Hypertensive patients with controlled BP on medication were allowed in the trial.

Only patients with severe uncontrolled hypertension are excluded:

"Hypertensive urgency (e.g., SBP >220 mmHg or DBP >120 mmHg) or hypertensive emergency within the last 72 hours..."

In other words stroke level hypertension was excluded

No exclusion listed for the following:
cancer patients, heart disease, asthma, Chronic obstructive pulmonary disease, epilepsy,diabetes, AIDS not requiring treatment,neurologic disorders,dementia, hematologic disorders, gastrointestinal disorders and most other chronic disorders which were well controlled.

Most of the rest of the exclusions are easily understandable

Individuals on ventilators and ECMO are excluded
Requiring systemic anti-infective therapy for suspected or confirmed active bacterial/fungal/viral systemic infection other than COVID-19.
Any serious medical or psychiatric condition or test abnormality(ies) that, in the investigator's judgment, puts the participant at significant risk, could confound the study results, or may interfere significantly with the subject's safe participation in and completion of the study.
Pregnancy or breast-feeding, or positive urine or serum pregnancy test in a pre-dose assessment.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception throughout the study and for up to 30 days after stopping treatment.

This study of other antiviral Covid treatments was discussed recently on the board. It is a good example of patients allowed in covid clinical trials:

https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00485-0/fulltext#coronavirus-linkback-header

Obesity 278 (34%) 138 (34%) 140 (34%)
Chronic cardiac disease 229 (28%) 111 (27%) 118 (28%)
Diabetes 217 (26%) 104 (26%) 113 (27%)
Chronic pulmonary disease 146 (18%) 71 (17%) 75 (18%)
Chronic kidney disease stage 1 to 3 51 (6%) 19 (5%) 32 (8%)
Auto-inflammatory disease 41 (5%) 17 (4%) 24 (6%)
Malignant haemopathy 35 (5%) 16 (4%) 19 (5%)
Chronic neurological disorder including dementia 34 (4%) 18 (4%) 16 (4%)
Mild liver disease 30 (4%) 15 (4%) 15 (4%)
Active malignant neoplasm 28 (3%) 13 (3%) 15 (4%)
Transplantation 11 (1%) 2 (<1%) 9 (2%)
Asplenia 4 (<1%) 1 (<1%) 3 (1%)
AIDS/HIV not on ART
Most moderately to severe covid patiets are older and many have other significant disease.


GLTA,

Farrell