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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | ProLectin M 1,400 mg Tab. Number of Doses -04 Dosing Frequency-once every 2 hours Total Dose/Day-5600 mg |
|
| Arm 2 | Experimental | ProLectin M 1,400 mg Tab. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-11200mg |
|
| Arm 3 | Experimental | ProLectin M 1,400 mg Tab. Number of Doses -12 Dosing Frequency-Hourly Total Dose/Day-16800 |
|
| Arm 4 | No Intervention | Matching Placebo. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-0 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolectin-M | Drug | Prolectin-M Precise chemistry based molecule that binds to galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change In Clinical Status | Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2 | Day 7 |
| 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 |
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Inclusion Criteria:Patients must meet all of the following criteria to be included in this study.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mr.Srivatsa GS | Contact | 6364147989 | sri@samahitha.com | |
| Ms.Keertana Shetty | Contact | 6364149749 | hr@samahitha.com |
| Name | Affiliation | Role |
|---|---|---|
| Sunitha Mali | Team Lead | Study Chair |
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The sponsors and the study representatives and other stakeholders will take a decision on completion of the trial
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C012990 | galactomannan |
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A Phase 1b/2a Randomized, Blinded, placebo-controlled Study
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Blinding will be maintained throughout the trial until database is locked after last patient last visit. Emergency unblinding will be allowed through a 24/7 helpline set up for any investigator / ethics committee member or others authorized to request for unblinding. Given
|
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |