NanoViricides Inc (NNVC)

[loanranger]

Just a few questions based on some of the info received to date:

1. How will the patient population be allocated between the cohorts in 1a and 1b?
Total Sample Size="72"
Intervention A. NV-CoV-2 Oral Gummy (Chewable gel):
Single dose(Phase 1a) once only in three cohorts of 500mg, 1000mg and 2000mg for oral administration via sub lingual route
Multi-dose (phase1b) once every alternate day for five dosing days once in day in three cohorts of 500mg, 1000mg and 2000mg for oral administration via sub lingual route

Intervention B. NV-CoV-2 Oral Syrup
Single dose (phase 1a) once only for oral administration in three cohorts of 10mg/kg; 20mg/kg and 40mg/kg.
Multi dose (phase 1b) once every alternate day for five dosing days by oral administration in three cohorts of 10mg/kg; 20mg/kg and 40mg/kg.

IF I understand the process (a big IF) each cohort will involve dosing at least one unique individual ( in other words the Single dose 1a requires at least 3 individuals, 1 for each dosage). There are 12 total cohorts in the two trials.

If one were to assume that the cohorts include an equal number of individuals the total sample size of 72 would include 6 patients in each cohort. Is that adequate to "Evaluate Both Safety and Initial Efficacy Indications in COVID patients" (as described in the Company's press release) to any degree of medical certainty?


2. Exactly how is the mild to moderate/severe population defined?
"Phase 1b to Begin Shortly:
In Phase 1b, healthy persons will be dosed with multiple doses of the Oral Syrup and separately, Oral Gummies to study Safety and Tolerability.
Additionally, in Phase 1b, in separate cohorts, patients with mild to moderate/severe COVID-19 shall be enrolled to assess indication of efficacy. Patients deemed by the physician to be likely to require hospitalization within 48 hrs of screening will be excluded."

The last sentence alters the terms of the study to be patients with mild to moderate/severe COVID-19 that aren't likely to be hospitalized in the next 48 hours, eliminating a chunk of the moderate/severe population. It also differs slightly from the actual exclusion criteria, which says:
"Likely need for hospital admission within 24 to 48 hrs of randomization as per the assessment of the physician. (SpO2- <94%)"


3. Inclusion criteria:
Age From 18.00 Year(s)
Age To 60.00 Year(s)
Obviously a decision was made to exclude the over 60 group, which is known to be the high risk age group. Why?
It may be a reasonable criteria to include, but it seems as if the trial wasn't exactly designed in a way that is consistent with the Diwan promotional effort.
From the press release:
"Thus we believe that NV-CoV-2 will be useable in all segments of patient populations, (i) in age from pediatric to geriatric, with otherwise healthy adults included; (ii) with or without co-morbidities; (iii) with disease manifestation from mild, moderate, severe to hospitalized stage.
In contrast, existing COVID therapeutics are limited in the treatable segment(s) of population; thus, Remdesivir is indicated for hospitalized patients only; Molnupiravir and Paxlovid are both indicated for patients over 65 years of age with co-morbidities that are not taking other drugs that would cause interactions. This leaves a large patient population that is unserved. "

What a pair of balls. He excludes the same or similar groups from the current 1a and 1b tests that he accuses existing treatments of failing to serve while saying "we believe that NV-CoV-2 will be useable in all segments of patient populations".

Read the underlined passage above and compare it to the following Inclusion and Exclusion Criteria from the current trial:
Inclusions: Age From 18.00 Year(s)/Age To 60.00 Year(s)

Exclusions: 1-Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood-forming organs.
2-History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
3-History of severe infection or major surgery in the past 6 months.


I'm not saying that the trial inclusion/exclusion criteria are unreasonable....they aren't. What is unreasonable is the promotion of a treatment as being "useable in all segments of patient populations, (i) in age from pediatric to geriatric, with otherwise healthy adults included; (ii) with or without co-morbidities; (iii) with disease manifestation from mild, moderate, severe to hospitalized stage" in a press release about a clinical trial that has been designed to avoid those issues without any mention of that fact while at the same time taking note of the failures of existing treatments.

It's shady and it's no surprise.


edit: Please consider adding the Clinical Trial registry as a Sticky: https://ctri.nic.in/Clinicaltrials/showallp.php?mid1=67454&EncHid=&userName=Karveer Meditech