COVID-19Prolectin-MNCT04512027
Prolectin-M in COVID-19 Patients Having Mild to Moderate Symptoms Not Requiring Oxygen Support.
A study testing Prolectin-M; a (1-6)-alpha-D-Mannopyranose class in people with COVID-19, run by Composite Interceptive Med Science at 1 site in India.
Trial summary
A randomised controlled trial of open label Prolectin-M; a (1-6)-alpha-D-Mannopyranose among patients with RT PCR positive COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Prolectin-M; a (1-6)-alpha-D-Mannopyranose class
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 15 Sep 2020to 16 Oct 2020
- Phase
- Interventional
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic and laboratory-confirmed diagnosis of COVID-19.
- Age ≥18 years and ≤45 years, male and non-pregnant female
- Identified within 72 hours of testing positive on RT PCR.
- Able to give informed consent to stay in institutional care and undergo 3 times collection of throat and nasal swabs over 7-day period; Day 1, Day 3 and Day 5 since randomization.
Who cannot join
- Oxygen saturation at admission ≤96%.
- High temperature ≥100 deg F (≥37.5 deg C) not controlled on oral doses of acetaminophen.
- Known history of diabetes on oral medications or insulin.
- IL-6 levels ≥ 3times of laboratory reference range and / or significantly elevated levels of CRP, serum ferritin or d-dimer.
- Lymphocyte / monocyte ratio ≤3 or neutrophil / lymphocyte ratio ≥5 or platelet count ≤150,000 cells per microliter
- On any chronic medications for more than 4 weeks before randomization or active malignancy or having any co-morbidity that increases risk of rapid disease progression.
- Previously tested positive and recovered from COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prolectin-M; a (1-6)-Alpha-D-Mannopyranose on SarsCoV2 Viral Copy Numbers: A Proof of Concept, Open Label Randomized Controlled Trial
A randomised controlled trial of open label Prolectin-M; a (1-6)-alpha-D-Mannopyranose among patients with RT PCR positive COVID-19 patients.
Read the detailed description
SarsCoV2 has infected over 20 million people worldwide. The virus has a unique protein structure enabling it to rapidly infect and spread among the population. COVID19 is a global health emergency and has affected lives of all people irrespective of being infected. There are no proven therapies and a vaccine is yet to be approved for wide public usage.
Our study aims to test a hypothesis of physically blocking the spike protein from infecting the human cells, thus promoting its rapid excretion from the infected person.
We will randomise 10 subjects in this proof of concept trial and test the hypothesis by measuring the effect of Prolectin-M; a (1-6)-alpha-D-Mannopyranose in reducing the viral copy numbers over 5 days of treatment. The absolute copy numbers will be measured on digital droplet PCR developed by BioRad. A fall in copy numbers by 2-fold from baseline will be considered a positive treatment effect in this population. All standard care measures currently being practiced for these patients will be continued.
- Conditions
- COVID-19
- Being tested
- Prolectin-M; a (1-6)-alpha-D-Mannopyranose class, Standard of Care
- Keywords
- ddPCR,, SarsCoV2 Copies
- 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-M; a (1-6)-alpha-D-Mannopyranose classOther
A treatment to decrease viral load, detected through digital droplet PCR, in mild to moderate cases of RT-PCR positive COVID-19
Standard of CareOther
Currently approved standard of care for patients without symptoms requiring hospitalisation will be provided to all.
| Study group | Role | What they receive |
|---|---|---|
| Prolectin-M; a (1-6)-alpha-D-Mannopyranose class+Stand of care | Experimental | Tablet chewed for 5 days along and given alongside standard of care Receives: Other: Prolectin-M; a (1-6)-alpha-D-Mannopyranose class; Other: Standard of Care |
| Standard of Care | No intervention | All patients will receive currently practiced standard of care medicines |
What is being measured
The primary outcome is the main question the study is designed to answer.
SarsCoV2 viral copy number
Change in absolute viral copy number
Measured: 7 days from randomisation
Secondary outcomes (1)
b. Disease progression will be measured on a 7-point scale at 28 days. A 2-point change will be considered disease progression.
7-point severity score (ordinal scale):
- Not hospitalized, no limitations on activities
- Not hospitalized, limitation on activities;
- Hospitalized, not requiring supplemental oxygen;
- Hospitalized, requiring supplemental oxygen;
- Hospitalized, on non-invasive ventilation or high flow oxygen devices;
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
- Death
Measured: 28 days from randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start15 Sep 2020
- Primary completion19 Sep 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Composite Interceptive Med Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioxytran Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512027
- Sponsor's protocol ID
- CIMED - 002- 2020
- Acronym
- Prolectin-M
- Status last verified
- Oct 2020
- First submitted
- 11 Aug 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suo T, Liu X, Feng J, Guo M, Hu W, Guo D, Ullah H, Yang Y, Zhang Q, Wang X, Sajid M, Huang Z, Deng L, Chen T, Liu F, Xu K, Liu Y, Zhang Q, Liu Y, Xiong Y, Chen G, Lan K, Chen Y. ddPCR: a more accurate tool for SARS-CoV-2 detection in low viral load specimens. Emerg Microbes Infect. 2020 Dec;9(1):1259-1268. doi: 10.1080/22221751.2020.1772678.
PubMed 32438868http://medrxiv.org/lookup/doi/10.1101/2020.02.29.20029439
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prolectin-M; a (1-6)-Alpha-D-Mannopyranose on SarsCoV2 Viral Copy Numbers: A Proof of Concept, Open Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04512027
- Acronym / sponsor ID
- Prolectin-M / CIMED - 002- 2020
- Conditions
- COVID-19
- Keywords
- ddPCR,, SarsCoV2 Copies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Composite Interceptive Med ScienceIndustry (pharma, biotech, devices)
- Collaborators
- Bioxytran Inc.
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 19 Sep 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 13 Aug 2020 (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.
A randomised controlled trial of open label Prolectin-M; a (1-6)-alpha-D-Mannopyranose among patients with RT PCR positive COVID-19 patients.
Detailed description
SarsCoV2 has infected over 20 million people worldwide. The virus has a unique protein structure enabling it to rapidly infect and spread among the population. COVID19 is a global health emergency and has affected lives of all people irrespective of being infected. There are no proven therapies and a vaccine is yet to be approved for wide public usage.
Our study aims to test a hypothesis of physically blocking the spike protein from infecting the human cells, thus promoting its rapid excretion from the infected person.
We will randomise 10 subjects in this proof of concept trial and test the hypothesis by measuring the effect of Prolectin-M; a (1-6)-alpha-D-Mannopyranose in reducing the viral copy numbers over 5 days of treatment. The absolute copy numbers will be measured on digital droplet PCR developed by BioRad. A fall in copy numbers by 2-fold from baseline will be considered a positive treatment effect in this population. All standard care measures currently being practiced for these patients will be continued.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolectin-M; a (1-6)-alpha-D-Mannopyranose class+Stand of care | Experimental | Other: Prolectin-M; a (1-6)-alpha-D-Mannopyranose class, Other: Standard of CareTablet chewed for 5 days along and given alongside standard of care |
| Standard of Care | No intervention | –All patients will receive currently practiced standard of care medicines |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Symptomatic and laboratory-confirmed diagnosis of COVID-19.
- Age ≥18 years and ≤45 years, male and non-pregnant female
- Identified within 72 hours of testing positive on RT PCR.
- Able to give informed consent to stay in institutional care and undergo 3 times collection of throat and nasal swabs over 7-day period; Day 1, Day 3 and Day 5 since randomization.
Key exclusion criteria (7 listed)
- Oxygen saturation at admission ≤96%.
- High temperature ≥100 deg F (≥37.5 deg C) not controlled on oral doses of acetaminophen.
- Known history of diabetes on oral medications or insulin.
- IL-6 levels ≥ 3times of laboratory reference range and / or significantly elevated levels of CRP, serum ferritin or d-dimer.
- Lymphocyte / monocyte ratio ≤3 or neutrophil / lymphocyte ratio ≥5 or platelet count ≤150,000 cells per microliter
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-M; a (1-6)-alpha-D-Mannopyranose classA treatment to decrease viral load, detected through digital droplet PCR, in mild to moderate cases of RT-PCR positive COVID-19 | Other | Prolectin-M; a (1-6)-alpha-D-Mannopyranose class+Stand of care |
| Standard of CareCurrently approved standard of care for patients without symptoms requiring hospitalisation will be provided to all. | Other | Prolectin-M; a (1-6)-alpha-D-Mannopyranose class+Stand of care |
Primary outcome
SarsCoV2 viral copy number
Time frame: 7 days from randomisation
Change in absolute viral copy number
1 secondary outcome
b. Disease progression will be measured on a 7-point scale at 28 days. A 2-point change will be considered disease progression.
Time frame: 28 days from randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 32438868Suo T, Liu X, Feng J, Guo M, Hu W, Guo D, Ullah H, Yang Y, Zhang Q, Wang X, Sajid M, Huang Z, Deng L, Chen T, Liu F, Xu K, Liu Y, Zhang Q, Liu Y, Xiong Y, Chen G, Lan K, Chen Y. ddPCR: a more accurate tool for SARS-CoV-2 detection in low viral load specimens. Emerg Microbes Infect. 2020 Dec;9(1):1259-1268. doi: 10.1080/22221751.2020.1772678.
- Backgroundhttp://medrxiv.org/lookup/doi/10.1101/2020.02.29.20029439
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolectin-M; a (1-6)-alpha-D-Mannopyranose class in people with COVID-19, run by Composite Interceptive Med Science at 1 site in India.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SarsCoV2 viral copy number (time frame: 7 days from randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04512027, which also lists 2 linked publications.
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 19 Oct 2020.