NCT04512027

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

4 days

First QC Date

August 11, 2020

Last Update Submit

October 16, 2020

Conditions

COVID-19

Keywords

ddPCR,SarsCoV2 Copies

Outcome Measures

Primary Outcomes (1)

  • SarsCoV2 viral copy number

    Change in absolute viral copy number

    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.

    28 days from randomisation

Study Arms (2)

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

Other: Prolectin-M; a (1-6)-alpha-D-Mannopyranose classOther: Standard of Care

Standard of Care

NO INTERVENTION

All patients will receive currently practiced standard of care medicines

Interventions

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

Prolectin-M; a (1-6)-alpha-D-Mannopyranose class+Stand of care
Standard of CareOTHER

Currently approved standard of care for patients without symptoms requiring hospitalisation will be provided to all.

Prolectin-M; a (1-6)-alpha-D-Mannopyranose class+Stand of care

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mazumdar Shaw Medical Centre

Bangalore, Karnataka, 560099, India

Location

Related Publications (2)

  • 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.

    PMID: 32438868BACKGROUND

  • http://medrxiv.org/lookup/doi/10.1101/2020.02.29.20029439

    BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 13, 2020

Study Start

September 15, 2020

Primary Completion

September 19, 2020

Study Completion

October 16, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)