To test safety, efficacy and pharmacokinetics of Prolectin-M in patients With COVID-19

Phase 2

• Conditions: Health Condition 1: U071- COVID 19 virus identified

• Registration Number: CTRI/2023/01/049327
• Lead Sponsor: Pharmalectin Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 the 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 10 days.

4. Females of childbearing potential who has been using highly effective contraception for at least 1 month prior to screening and agree continue using it during the study participation/enrolment,

confirmed through negative pregnancy test

Exclusion Criteria

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

2. Female patients who are pregnant or breastfeeding.

3. Patients with any active malignancy or undergoing active chemotherapy.

4. Patients who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening.

5. 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.

6. 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