Carbohydrate ProLectin M, a Gelectin-3 Antagonist to block SARS-CoV2 Activity

Not Applicable

Completed

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2022/03/040757

Lead Sponsor: Dr Surender Reddy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Male or Female patient of >=â??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.

2. 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:

i. Ct value <= 25

ii. Hospitalized for having classical (CDC defined)

symptoms of COVID-19 (onset <= 5 days)

iii. 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.

3. 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 29 days.

4. 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

Exclusion Criteria

Oxygen Saturation levels (SpO2) <= 94% on room air.

6. Female patients who are pregnant or breastfeeding.

7. Patients with any active malignancy or undergoing active

chemotherapy.

8. Patients who are currently receiving or have received any

investigational treatment for COVID-19 within 30 days prior to

screening.

9. In the opinion of the Investigator, the participation of the patient

in the study is not in the patientâ??s best interest, or the patient

has any medical condition that does not allow the study

protocol to be followed safely.

10. Patients with known allergies to any of the components used in

the formulation of the interventions.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to non-detection of viral shedding in outpatient swab, <br/ ><br>detecting quantitative SARS-CoV-2 in nasopharynx <br/ ><br> <br/ ><br>Proportion of patients who show <br/ ><br>improvement will be compared between the two groups <br/ ><br>Timepoint: baseline at 0 day, day 3, 5,7, 14 and 28 post recruitment

Secondary Outcome Measures