To Evaluate the Safety, Efficacy,and Pharmacokinetics of Orally Administered Prolectin-M

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1b/2a Randomized, Blinded, Placebo-controlled Study in Participants With Mild to Moderate COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Orally Administered ProLectin-M

Conditions
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COVID-19, SARS CoV 2 Infection

Intervention / Treatment
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* Drug: Prolectin-M


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Patients must meet all of the following criteria to be included in this study. 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. 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. 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. 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. Oxygen Saturation levels (SpO2) ≤ 94% on room air. Female subjects who are pregnant or breastfeeding. Subjects with any active malignancy or undergoing active chemotherapy. Subjects who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening. Subjects with a history of hypercalcemia or serum calcium concentration >10mg/dl Subjects currently on concomitant medication that can contains calcium, elevate serum calcium levels, or exacerbate hypercalcemia (Ex. Lithium, thiazide diuretics etc.). 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.) 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. Subjects with known allergies to any of the components used in the formulation of the interventions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Phase 1b/2a Randomized, Blinded, placebo-controlled Study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>ProLectin M 1,400 mg Tab. Number of Doses -04 Dosing Frequency-once every 2 hours Total Dose/Day-5600 mg | Drug: Prolectin-M<br>* Prolectin-M Precise chemistry based molecule that binds to galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus<br>* Other names: Galactomannan;|
| Experimental: Arm 2<br>ProLectin M 1,400 mg Tab. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-11200mg | Drug: Prolectin-M<br>* Prolectin-M Precise chemistry based molecule that binds to galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus<br>* Other names: Galactomannan;|
| Experimental: Arm 3<br>ProLectin M 1,400 mg Tab. Number of Doses -12 Dosing Frequency-Hourly Total Dose/Day-16800 | Drug: Prolectin-M<br>* Prolectin-M Precise chemistry based molecule that binds to galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus<br>* Other names: Galactomannan;|
| No Intervention: Arm 4<br>Matching Placebo. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-0 mg | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change In Clinical Status | Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2 | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Outcome | Proportion of participants with treatment-emergent AEs (TEAEs) and laboratory abnormalities. | from time of signing informed consent till day 14 | 
| Safety Outcome | Proportion of participants with TEAEs leading to study treatment discontinuation | from time of signing informed consent till day 14 | 
| Mortality | Mortality rate by Day 14 | 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 | Day 7 | 
| Time to discharge of viral load | Time to negative SARS-CoV-2 polymerase chain reaction (PCR) | 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 | from time of signing informed consent till day 14 | 
| Safety Outcome | Rate of adverse events | 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 | Day 3 and Day 5 |