ProLectin M is an orally administered polysaccharide. Polysaccharides competitively bind to the N-terminal tail of human galectin-3 through a proline isomerization \[10\]. Galetin-3 (Gal-3) is 1 among the 15 galectins described in humans and also a ubiquitous human galectin expressed in various disease pathogenesis pathways \[11\]. The objective of this clinical study is to evaluate the safety and efficacy of a galectin antagonist, ProLectin M (a Guar Gum Galactomannan), in the treatment of subjects with asymptomatic to moderately-severe, ambulatory COVID-19 patients.
This trial will test the efficacy of ProLectin M in lowering viral load among those infected with SARS-CoV-2. Viral load will be measured using nucleic acid amplification-based diagnostics, RT-PCR. The RT-PCR will measure an absolute increase in cycle threshold values from baseline. ProLectin M (a guar gum galactomannan), an oral form of galectin antagonist could treat COVID-19 patients. When given early in the disease pathogenesis and the viral replication is stopped, it can prevent further spread of SARS-CoV-2 among the household contacts and their community.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
40
Prolectin-M Precise chemistry based molecule that binds to galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus
Change In Clinical Status
Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2
Time frame: Day 7
Safety Outcome
Proportion of participants with treatment-emergent AEs (TEAEs) and laboratory abnormalities.
Time frame: from time of signing informed consent till day 14
Safety Outcome
Proportion of participants with TEAEs leading to study treatment discontinuation
Time frame: from time of signing informed consent till day 14
Mortality
Mortality rate by Day 14
Time frame: from time of signing informed consent till day 14
Plasma Concentration of PL-M
Characterization of the plasma concentrations of ProLectin-M and its metabolites including AUC0 24h, AUClast, CLss/F, t1/2, Vz/F, Cmax, Tmax, Clast, Tlast, AUCtau, λz, and Ctau
Time frame: Day 7
Time to discharge of viral load
Time to negative SARS-CoV-2 polymerase chain reaction (PCR)
Time frame: from time of signing informed consent till day 14
Change in Clinical Status from Baseline to End of the study
Time to alleviation (absent) of baseline COVID- 19 symptoms as reported on the WHO clinical progression scale
Time frame: from time of signing informed consent till day 14
Safety Outcome
Rate of adverse events
Time frame: from time of signing informed consent till day 14
Change in Clinical Status
Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2 Outcome TimePoints Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2
Time frame: Day 3 and Day 5
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