To Evaluate the Safety, Efficacy,and Pharmacokinetics of Orally Administered Prolectin-M
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
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, rRT-PCR and ddPCR. The rRT-PCR will measure an absolute increase in cycle threshold values from baseline and the ddPCR will measure an absolute drop to undetectable values of viral copy numbers within 5 days of drug administration.
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 ProLectin M 1,400 mg Tab. Number of Doses -04 Dosing Frequency-once every 2 hours Total Dose/Day-5600 mg |
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 Names:
|
| Experimental: Arm 2 ProLectin M 1,400 mg Tab. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-11200mg |
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 Names:
|
| Experimental: Arm 3 ProLectin M 1,400 mg Tab. Number of Doses -12 Dosing Frequency-Hourly Total Dose/Day-16800 |
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 Names:
|
| No Intervention: Arm 4 ProLectin M 1,400 mg Tab. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-0 mg |
Outcome Measures
Primary Outcome Measures
- Change In Clinical Status [Time frame: Day 3, 5, and 7]
Time to non-detection of viral shedding in outpatient swab, detecting quantitative SARS-CoV-2 in nasopharynx at intervals of days Day 3, 5, and 7. The disease severity will be measured in terms of severity of symptoms on a WHO clinical progression scale. The percentage of patients remaining or moving up or down the scale by 2 or more points by day 3, 5, 7 and 10 days will be compared.
Secondary Outcome Measures
- Safety Outcome [from time of signing informed consent till day 90]
Proportion of participants with treatment-emergent AEs (TEAEs) and laboratory abnormalities.
- Safety Outcome [from time of signing informed consent till day 90]
Proportion of participants with TEAEs leading to study treatment discontinuation
- Mortality /SAE [from time of signing informed consent till day 90]
Mortality rate by Day 90
- Plasma Concentration of PL-M [Day 7]
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 to discharge of viral load [day 3 ,day 5, and day 7]
Change in SARS-CoV-2 viral load from baseline to Day 3, 5, and 7
- Time to discharge of viral load [Day 3, 5, and 7]
Change in SARS-CoV-2 Ct-value from baseline to Day 3, 5, and 7
- Time to discharge of viral load [from time of signing informed consent till day 90]
Time to negative SARS-CoV-2 polymerase chain reaction (PCR)
- Change in Clinical Status from Baseline to End of the study [from time of signing informed consent till day 90]
Time to alleviation (absent) of baseline COVID- 19 symptoms as reported on the WHO clinical progression scale
- Safety Outcome [from time of signing informed consent till day 90]
Rate of adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:Patients must meet all of the following criteria to be included in this study.
-
Male or Female patient 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.
-
Patient having a positive diagnosis for presence of SARS-CoV- 2, obtained from a recently performed rRT-PCR (≤ 3 days) with any 1 of the following:
- Ct value ≤ 25. ii. Hospitalized for having classical (CDC defined) symptoms of COVID-19 (onset ≤ 5 days).
- High risk category of COVID-19: blood group type A-positive, type 2 diabetes, or other chronic disease known to have higher morbidity risk with SARS-CoV-2 infection.
-
Patient has the ability to take oral medication and be willing to adhere to the trial protocol regimen of repeated swab collections and frequent follow up for 10 days.
-
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 patients who are pregnant or breastfeeding.
-
Patients with any active malignancy or undergoing active chemotherapy.
-
Patients who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening.
-
In the opinion of the Investigator, the participation of the patient in the study is not in the patient's best interest, or the patient has any medical condition that does not allow the study protocol to be followed safely.
-
Patients with known allergies to any of the components used in the formulation of the interventions.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Bioxytran Inc.
Investigators
- Study Chair: Sunitha Mali, Team Lead
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTSRS/2205