Clinical trial NCT04512027: Prolectin-M in COVID-19 Patients Having Mild to Moderate Symptoms Not Requiring Oxygen Support.
Official title: Effect of Prolectin-M; a (1-6)-Alpha-D-Mannopyranose on SarsCoV2 Viral Copy Numbers: A Proof of Concept, Open Label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: ddPCR,
SarsCoV2 Copies
Lead sponsor: Composite Interceptive Med Science
Sponsor class: INDUSTRY
Collaborators: name: Bioxytran Inc.
First posted: 2020-08-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised controlled trial of open label Prolectin-M; a (1-6)-alpha-D-Mannopyranose among patients with RT PCR positive COVID-19 patients.

Detailed description: SarsCoV2 has infected over 20 million people worldwide. The virus has a unique protein structure enabling it to rapidly infect and spread among the population. COVID19 is a global health emergency and has affected lives of all people irrespective of being infected. There are no proven therapies and a vaccine is yet to be approved for wide public usage.

Our study aims to test a hypothesis of physically blocking the spike protein from infecting the human cells, thus promoting its rapid excretion from the infected person.

We will randomise 10 subjects in this proof of concept trial and test the hypothesis by measuring the effect of Prolectin-M; a (1-6)-alpha-D-Mannopyranose in reducing the viral copy numbers over 5 days of treatment. The absolute copy numbers will be measured on digital droplet PCR developed by BioRad. A fall in copy numbers by 2-fold from baseline will be considered a positive treatment effect in this population. All standard care measures currently being practiced for these patients will be continued.

Eligibility criteria: Inclusion Criteria:

* Symptomatic and laboratory-confirmed diagnosis of COVID-19.
* Age ≥18 years and ≤45 years, male and non-pregnant female
* Identified within 72 hours of testing positive on RT PCR.
* Able to give informed consent to stay in institutional care and undergo 3 times collection of throat and nasal swabs over 7-day period; Day 1, Day 3 and Day 5 since randomization.

Exclusion Criteria:

* Oxygen saturation at admission ≤96%.
* High temperature ≥100 deg F (≥37.5 deg C) not controlled on oral doses of acetaminophen.
* Known history of diabetes on oral medications or insulin.
* IL-6 levels ≥ 3times of laboratory reference range and / or significantly elevated levels of CRP, serum ferritin or d-dimer.
* Lymphocyte / monocyte ratio ≤3 or neutrophil / lymphocyte ratio ≥5 or platelet count ≤150,000 cells per microliter
* On any chronic medications for more than 4 weeks before randomization or active malignancy or having any co-morbidity that increases risk of rapid disease progression.
* Previously tested positive and recovered from COVID-19

Primary outcomes:
measure: SarsCoV2 viral copy number
timeFrame: 7 days from randomisation
Secondary outcomes:
measure: b. Disease progression will be measured on a 7-point scale at 28 days. A 2-point change will be considered disease progression.
timeFrame: 28 days from randomisation
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Mazumdar Shaw Medical Centre
state: Karnataka
Study officials:
References:
citation: Suo T, Liu X, Feng J, Guo M, Hu W, Guo D, Ullah H, Yang Y, Zhang Q, Wang X, Sajid M, Huang Z, Deng L, Chen T, Liu F, Xu K, Liu Y, Zhang Q, Liu Y, Xiong Y, Chen G, Lan K, Chen Y. ddPCR: a more accurate tool for SARS-CoV-2 detection in low viral load specimens. Emerg Microbes Infect. 2020 Dec;9(1):1259-1268. doi: 10.1080/22221751.2020.1772678.
citation: http://medrxiv.org/lookup/doi/10.1101/2020.02.29.20029439