Clinical Study on Nichi Glucan to Verify Effectiveness on Covid19

Phase 3

Not yet recruiting

Conditions: Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2021/10/037380

Lead Sponsor: NichiIn Bio Sciences Pvt Ltd

Brief Summary: **Study Design:** An Open Label, Prospective, Randomized, Comparative Clinical Study **Indication:** Covid-19 **Investigational Product:** Conventional Therapy and Nichi Glucan -AFO-202- and Nichi Glucan Refix -N-163 **Comparator:** Conventional Therapy

**Dose** **Nichi Glucan -AFO-202**- 1 g **Nichi Glucan Refix -N-163**-10g

**Dosage** **Nichi Glucan -AFO-202**- 1 g sachets thrice daily with meals **Nichi Glucan Refix -N-163**-10g gel sachet once daily

**Subject Population**-Adult subjects between 18 and 65 years -both ages and sexes-inclusive- who are confirmed to be positive for SARS-CoV2 by way of RT-PCR in a laboratory approved by MoH-FW and the State Government.

**Number of Subjects:** 100 Evaluable Subjects

**Treatment Arms**

Group I: Standard treatment (Control) 50 Subjects Group II: Standard treatment along with food supplement Nichi Glucan AFO-202 -1 g sachet thrice daily with meals- and N-163 -10g gel sachet once daily (50 Subjects)

**Treatment Duration :** 60 days per enrolled subject

**Assessments**

Blood Tests Complete blood count â€“CBC-, D-Dimer, C-reactive protein â€“CRP-, Erythrocyte Sedimentation rate â€“ESR-, Fasting â€“FBG- and post-prandial â€“PPG- blood glucose, HbA1C, Lipid profile, Liver function test, Ferritin **Tests on Day 0 and repeated on Day 15, Day 30 and Day 60**

COVID-19 Clinical Symptoms Time taken for improvement, complete recovery, recurrence in typical symptoms not limited to pyrexia, respiratory distress, cephalic and malaise -Day 0 and repeated on Day 15, Day 30 and Day 60

**Background of the study:**The ongoing COVID-19 pandemic caused by the novel Corona virus CoV strain -2019-nCoV-, termed severe acute respiratory syndrome CoV-2 -SARS-CoV-2- has led to 205,338,159 confirmed cases of COVID-19, including 4,333,094 deaths, worldwide. Current supportive care measures such as ventilation oxygenation and fluid management remain the standard of care. Current pharmacological treatment can provide partial or complete recovery despite their adverse effects. An alternative treatment with food supplements with higher level of safety and effectiveness are needed.

**Purpose of the Study:**Nichi Glucan is a food supplement containing 1,3-1,6 Beta Glucan which is a dietary fiber obtained from a black yeast known as the Aureobasidium pullulans strains AFO- 202- Nichi Glucan- and N-163 -Nichi Glucan Refix-. Nichi glucan has many beneficial effects on improving metabolism, boosting immunity, maintaining blood sugar levels etc. This clinical study is done to evaluate the Immunomodulatory Efficacy of Nichi Glucan in Comparison with Conventional Therapeutic Regimen in Adult Subjects with Covid-19 caused by SARS-COV2 (B-COV)

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Adult subjects between 18 and 65 years -both ages and sexes-inclusive- who are confirmed to be positive for SARS-CoV2 by way of RT-PCR in a laboratory approved by MoH-FW and the State Government.
Patients with co-morbidities can be included.
Patients who are found to be Covid19 positive requiring hospitalization.
Symptomatic or asymptomatic- 4.
Patients and LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period.
Patients who are willing not to participate in any other clinical trial during participation in the current trial.

Exclusion Criteria

Patients who are known to be HIV, HBV, HCV positive.
Patients who have clinically abnormal renal or hepatic function values that are 3x times normal upper limit or in the opinion of the Investigator would impact the objectives of the study.
Patients with complete cancer remission less than 3 years prior to the date of screening.
Patients who have undergone major surgical procedure 4 weeks prior to randomization.
Patients who are on anti-depressants, anti-psychotics.
Patients with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; expect those that are considered etiology of said indication 7.
Females who are pregnant or nursing or planning to become pregnant during the study period.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Immunology: IL-2, IL6, IgA	Day 0, Day 7, Day 15, Day 30, Day 60
2. Hospitalisation: Mortality, Duration of hospital stay, Need for Oxygen or Life-support	Day 0, Day 7, Day 15, Day 30, Day 60
3. Blood Test :Complete blood count â€“CBC-, D-Dimer, C-reactive protein â€“CRP-, Erythrocyte Sedimentation rate â€“ESR-, Fasting â€“FBG- and post-prandial â€“PPG- blood glucose, HbA1C, Lipid profile, Liver function test, Ferritin	Day 0, Day 7, Day 15, Day 30, Day 60

Secondary Outcome Measures

Name	Time	Method
COVID-19 Clinical Symptoms: Time taken for improvement, complete recovery, recurrence in typical symptoms not limited to pyrexia, respiratory distress, cephalic, malaise from baseline.	Day 0, Day 7, Day 15, Day 30, Day 60

Trial Locations

Locations (1): Madras Medical College (Affiliated to the Tamil Nadu MGR Medical University)
🇮🇳
Chennai, TAMIL NADU, India
Madras Medical College (Affiliated to the Tamil Nadu MGR Medical University)
🇮🇳Chennai, TAMIL NADU, India
Dr Pushkala S
Principal investigator
9042932009
pushkala.s@tnmgrmu.ac.in