COVID-19Phase 2NCT05733780
To Evaluate the Safety, Efficacy,and Pharmacokinetics of Orally Administered Prolectin-M
A Phase 2 study testing Prolectin-M in people with COVID-19 and SARS CoV 2 Infection, run by Bioxytran Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS CoV 2 Infection
- What is being tested?
- Prolectin-M
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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.
Read the 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, 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.
- Conditions
- COVID-19, SARS CoV 2 Infection
- Being tested
- Prolectin-M
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolectin-MDrug
Also called Galactomannan
Prolectin-M
Precise chemistry based molecule that binds to galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | ProLectin M 1,400 mg Tab. Number of Doses -04 Dosing Frequency-once every 2 hours Total Dose/Day-5600 mg Receives: Drug: Prolectin-M |
| Arm 2 | Experimental | ProLectin M 1,400 mg Tab. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-11200mg Receives: Drug: Prolectin-M |
| Arm 3 | Experimental | ProLectin M 1,400 mg Tab. Number of Doses -12 Dosing Frequency-Hourly Total Dose/Day-16800 Receives: Drug: Prolectin-M |
| Arm 4 | No intervention | Matching Placebo. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In Clinical Status
Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2
Measured: Day 7
Secondary outcomes (8)
Safety Outcome
Proportion of participants with treatment-emergent AEs (TEAEs) and laboratory abnormalities.
Measured: from time of signing informed consent till day 14
Safety Outcome
Proportion of participants with TEAEs leading to study treatment discontinuation
Measured: from time of signing informed consent till day 14
Mortality
Mortality rate by Day 14
Measured: 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
Measured: Day 7
Time to discharge of viral load
Time to negative SARS-CoV-2 polymerase chain reaction (PCR)
Measured: 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
Measured: from time of signing informed consent till day 14
Safety Outcome
Rate of adverse events
Measured: 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
Measured: Day 3 and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study startSep 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Phase 1b/2a Randomized, Blinded, placebo-controlled Study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioxytran Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunitha Mali, Study chair, Team Lead
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733780
- Sponsor's protocol ID
- CTSRS/2205
- Status last verified
- Sep 2023
- First submitted
- 26 Dec 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsors and the study representatives and other stakeholders will take a decision on completion of the trial
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05733780
- Acronym / sponsor ID
- CTSRS/2205
- Conditions
- COVID-19, SARS CoV 2 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bioxytran Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- A Phase 1b/2a Randomized, Blinded, placebo-controlled Study
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Prolectin-MProLectin M 1,400 mg Tab. Number of Doses -04 Dosing Frequency-once every 2 hours Total Dose/Day-5600 mg |
| Arm 2 | Experimental | Drug: Prolectin-MProLectin M 1,400 mg Tab. Number of Doses -08 Dosing Frequency-Hourly Total Dose/Day-11200mg |
| Arm 3 | Experimental | Drug: Prolectin-MProLectin 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolectin-MAlso: GalactomannanProlectin-M Precise chemistry based molecule that binds to galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus | Drug | Arm 1, Arm 2, Arm 3 |
Primary outcome
Change In Clinical Status
Time frame: Day 7
Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2
8 secondary outcomes
Safety Outcome
Time frame: from time of signing informed consent till day 14
Safety Outcome
Time frame: from time of signing informed consent till day 14
Mortality
Time frame: from time of signing informed consent till day 14
Plasma Concentration of PL-M
Time frame: Day 7
Time to discharge of viral load
Time frame: from time of signing informed consent till day 14
Change in Clinical Status from Baseline to End of the study
Time frame: from time of signing informed consent till day 14
Safety Outcome
Time frame: from time of signing informed consent till day 14
Change in Clinical Status
Time frame: Day 3 and Day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No. The sponsors and the study representatives and other stakeholders will take a decision on completion of the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunitha Mali study chair
Team Lead
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prolectin-M in people with COVID-19 and SARS CoV 2 Infection, run by Bioxytran Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mr.Srivatsa GS (6364147989, sri@samahitha.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change In Clinical Status (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.