ProLectin M is an orally administered polysaccharide. Polysaccharides competitively bindto 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 ubiquitoushuman galectin expressed in various disease pathogenesis pathways [11].The objective of this clinical study is to evaluate the safety and efficacy of a galectinantagonist, ProLectin M (a Guar Gum Galactomannan), in the treatment of subjects withasymptomatic 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.
Drug: Prolectin-M
Prolectin-M
Precise chemistry based molecule that binds to galectin like receptors on the N terminal
of S1 subunit of the Sars-CoV2 virus
Other Name: Galactomannan
Inclusion Criteria:Patients must meet all of the following criteria to be included in
this study.
1. Male or Female subject of ≥ 18 years of age, willing and able to provide written
informed consent for participation in the study and ready to comply with the study
procedures and schedule.
2. Subject having a positive diagnosis for presence of SARS-CoV- 2, obtained from a
recently performed RT-PCR (≤ 3 days) with a Ct value ≤ 25.
3. Subject has the ability to take oral medication and be willing to adhere to the
trial protocol regimen of repeated nasopharyngeal swab collections and follow up
till day 14.
4. Females of child bearing potential who has been using a highly effective
contraception for at least 1 month prior to screening and agrees to continue using
it during the study participation/enrolment, confirmed through negative pregnancy
test.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from this study.
1. Oxygen Saturation levels (SpO2) ≤ 94% on room air.
2. Female subjects who are pregnant or breastfeeding.
3. Subjects with any active malignancy or undergoing active chemotherapy.
4. Subjects who are currently receiving or have received any investigational treatment
for COVID-19 within 30 days prior to screening.
5. Subjects with a history of hypercalcemia or serum calcium concentration >10mg/dl
6. Subjects currently on concomitant medication that can contains calcium, elevate
serum calcium levels, or exacerbate hypercalcemia (Ex. Lithium, thiazide diuretics
etc.).
7. Subjects currently on calcium-binding (chelation) concomitant medication that may
result in reduction in absorption (e.g. fluroquinolone, bisphosphonates, antivirals
such as integrase strand transfer inhibitors, antibiotics such as quinolones,
tetracyclines etc.)
8. In the opinion of the Investigator, the participation of the subject in the study is
not in the subject's best interest, or the subject has any medical condition that
does not allow the study protocol to be followed safely.
9. Subjects with known allergies to any of the components used in the formulation of
the interventions.
Not Provided
Mr.Srivatsa GS
6364147989
sri@samahitha.com
Ms.Keertana Shetty
6364149749
hr@samahitha.com
Sunitha Mali, Study Chair
Team Lead