ImmunoModulatory Efficacy of Nichi Glucan in Covid19 Patients.

Recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/12/030051
• Lead Sponsor: Medi Nippon Health Care Private Limited

Brief Summary

StudyDesign :  An Open Label, Prospective, Randomised, Comparative, TwoArm Clinical Study Investigational Product : Nichi Glucan Comparator :  None. Conventional Therapy only to be provdied. Indication : Covid19 caused by SARS-COV2 (beta COV) Subject Population : Adult Subjects aged between 18 and 65 years ( bothages all sexes inclusive) who are confirmed to be positive for SARS-COV2 by wayof RT-PCR in a laboratory approved by MoH-FW and the State Government Number of Subjects : 48 Subjects Treatment Arms : Two Treatment Arm I : Nichi Glucan + Conventional Therapy : 24 Subjects Treatment Arm II : Conventional Therapy : 24 Subjects Treatment Duration : Maximum of 30 days per enrolled Subject Assessments 1. Covid19 Clinical Symptoms : Day 1, Day 15, Day 30 2. RT PCR : Day 1, Day 15, Day 30 3. Immunological Parameters : Day 1, Day 15, Day 30 4. Hospitalisation Parameters : Day 1, Day 15, Day 30 5. Blood Parameters : Day 1, Day 15, Day 30 6. Chest Scan : Day 1, Day 15, Day 30 7. Quality of Life Questionnaire : Day 15, Day 30

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Last Update Posted: 2021-10-30

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 1.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.
• 2.Subjects with co-morbidities can be included.
• To be analysed as cohort.
• 3.Subjects who are found to be Covid19 positive requiring hospitalization.
• (symptomatic or asymptomatic) 4.Subject and LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period.
• 5.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

Exclusion Criteria

• 1.Subjects who have previously been infected with SARS-CoV2 (symptomatic or asymptomatic) and recovered.
• 2.Subjects who are known to be HIV, HBV, HCV positive.
• 3.Subjects 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.
• 4.Subjects with complete cancer remission less than 3 years prior to the date of screening.
• 5.Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
• 6.Subjects who are on anti-depressants, anti-psychotics.
• 7.Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; except those that are considered etiology of said indication.
• 8.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.Covid19 Clinical Symptoms: Time taken for improvement, complete recovery, recurrence in typical symptoms not limited to pyrexia, respiratory distress, cephalgia, malaise from baseline.	Covid19 Clinical Symptoms: Day 1, Day 15, Day 30 | RT PCR: Day 1, Day 15, Day 30
2.RT PCR: Time taken for negative RT PCR Result from baseline.	Covid19 Clinical Symptoms: Day 1, Day 15, Day 30 | RT PCR: Day 1, Day 15, Day 30
3.RT PCR : Reduction of titer/severity level from baseline.	Covid19 Clinical Symptoms: Day 1, Day 15, Day 30 | RT PCR: Day 1, Day 15, Day 30

Secondary Outcome Measures

Name	Time	Method
Immunology : CD4, CD8, CD56, CD13, IgA, IL6	Hospitalisation : Mortality, ICU admission, Oxygen/LifeSupport

Trial Locations

Locations (1)

Yashoda Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Yashoda Hospitals

🇮🇳Hyderabad, TELANGANA, India

Dr Naveen Reddy

Principal investigator

04045674567

drnaveenreddy@yahoo.com