Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: N-163 and AFO-202: AFO-202- 3 gm per day (1 gm per each meal)
N-163- 1 sachet per day
Control Intervention1: Standard Treatment and N-163 and AFO-202: Inj. Remdesivir 200 mg (Day 1)
In
Sponsors
NichiIn Biosciences Pvt Ltd
GN Corporation Co Ltd
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. Patients with co-morbidities can be included. 3. 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. 5. Patients who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously been infected with SARS-CoV2 (symptomatic or Asymptomatic ) and recovered. 2. Patients who are known to be HIV, HBV, HCV positive. 3. 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. 4. Patients with complete cancer remission less than 3 years prior to the date of screening. 5. Patients who have undergone major surgical procedure 4 weeks prior to randomization. 6. Patients who are on anti-depressants, anti-psychotics. 7. 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 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, cephalic, malaise from baseline.Timepoint: 7th day or 14th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Immunology : CD4, CD8, CD56, CD13, IgA, IL6 2. Hospitalization : Mortality, ICU admission, Oxygen/Life-support 3. Blood Test : D-Dimer, CRP, ESR, FBG 4. Chest Scan : CT Lung Timepoint: Monitoring Adverse events everyday | — |
Countries
India
Contacts
Public ContactDr S R Tiruvalavan
Shanmuga Hospital Pvt Ltd
Outcome results
None listed