Health Condition 1: B338- Other specified viral diseases
Conditions
Interventions
Intervention1: Tab. ProLectin-M: Arm 1: Tab. ProLectin-M daily dose of 5,600 mg/day (1400 mg x 4 doses – one dose every 2 hours) + Standard of Care (SOC)
Arm 2: Tab. ProLectin-M daily dose of 11,200
Sponsors
Pharmalectin Inc, USA.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female subject of = 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. Subject having a positive diagnosis for presence of SARS-CoV- 2, obtained from a recently performed RT-PCR (= 3 days) with a Ct value = 25. 3. Subject has the ability to take oral medication and be willing to adhere to the trial protocol regimen of repeated nasopharyngeal swab collections and follow up till day 14. 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 participation/enrolment, confirmed through negative pregnancy test.
Exclusion criteria
Exclusion criteria: 1. Oxygen Saturation levels (SpO2) = 94% on room air. 2. Female subjects who are pregnant or breastfeeding. 3. Subjects with any active malignancy or undergoing active chemotherapy. 4. Subjects who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening. 5. Subjects with a history of hypercalcemia or serum calcium concentration >10mg/dl 6. Subjects currently on concomitant medication that can contains calcium, elevate serum calcium levels, or exacerbate hypercalcemia (Ex. Lithium, thiazide diuretics etc.). 7. 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.) 8. 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. 9. Subjects with known allergies to any of the components used in the formulation of the interventions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2Timepoint: Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-detection of viral shedding in nasopharyngeal swab detecting qualitative SARS-CoV-2Timepoint: Day 3 and Day 5;Proportion of participants with treatment-emergent AEs (TEAEs) and laboratory abnormalitiesTimepoint: All days;Proportion of participants with TEAEs leading to study treatment discontinuationTimepoint: All days;Mortality rateTimepoint: Day 14;Characterization of the plasma concentrations of ProLectin-M and pharmacokinetic parameters such as Cmax, AUC0-t, AUC0-8, t1/2, Tmax, Kel, and AUC0-t/AUC0-8 Timepoint: Baseline, Day 3, Day 5 and Day 7;Change in SARS-CoV-2 Ct-valueTimepoint: All days;Time to alleviation (absent) of baseline COVID-19 symptoms as reported on the WHO clinical progression scaleTimepoint: All days;Rate of adverse eventsTimepoint: All days | — |
Countries
India
Contacts
Public ContactDr D Sathish Kumar
G7 Synergon Private Limited
Outcome results
None listed