Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Nichi Glucan: Nichi Glucan is provided along with Conventional Therapy
Dose : 0.5 g x 6 sachets per day â?? 3 gm
2 sachets to be taken 30 minutes after a meal thrice daily
Duration : 30 Days
Route of Administration : Oral
Control Intervention1: None. Only Conventional Therapy to be provided.: None. Only Conve
Sponsors
Medi Nippon Health Care Private Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Covid19 Clinical Symptoms: Time taken for improvement, complete recovery, recurrence in typical symptoms not limited to pyrexia, respiratory distress, cephalgia, malaise from baseline. 2. RT PCR: Time taken for negative RT PCR Result from baseline. 3. RT PCR : Reduction of titer/severity level from baseline.Timepoint: Covid19 Clinical Symptoms: Day 1, Day 15, Day 30 RT PCR: Day 1, Day 15, Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunology : CD4, CD8, CD56, CD13, IgA, IL6 Hospitalisation : Mortality, ICU admission, Oxygen/LifeSupport Blood Test : D-Dimer, CRP, ESR, FBG Chest Scan : CT Lung QoL QuestionnaireTimepoint: Immunological Parameters: Day 1, Day 15, Day 30 Hospitalization parameters: Day 15, Day 30 Blood Parameters: Day 1, Day 15, Day 30 Chest Scan: Day 1, Day 15, Day 30 Quality of life Questionnaire : Day 15, Day 30 | — |
Countries
India
Contacts
Public ContactDr R Senthilkumar
Medi Nippon Health Care Private Limited
Outcome results
None listed