Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: ImmunoSEB plus ProbioSEB
CSC3: ImmunoSEB Capsule / 500 mg
2 capsule bid and ProbioSEB
CSC3 Capsule / 5 billion CFUs
2 Capsule OD for 14 day.
Control Intervention1: Standard Care: standa
Sponsors
Chirayu Medical College and Hospital
Chirayu Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient who provides written informed consent 2.Male or non-pregnant, non-lactating female aged 18 to 75 years (both inclusive) 3.RT-PCR confirmed diagnosis of COVID-19 4.Able to take the drug orally and comply with study procedures 5.Women of childbearing potential must have a negative urine pregnancy test prior to study entry
Exclusion criteria
Exclusion criteria: 1. Severe Type Respiratory distress, RR >30 times/min Finger oxygen saturation Arterial partial pressure of oxygen (PaO2)/concentration of oxygen inhalation FiO2 >300mmHg 2. Critical type: meeting any of the following criteria Respiratory failure occurs and mechanical ventilation is required Patients go into shock ICU is needed for other organ failure. 3.Patients who have received tumor immunotherapy such as PD-1/L1 CTLA4 etc. in the past 1 month, and inflammatory factor modulators such as Ulinastatin. 4.other viral pneumonia 5.patients who have received tumor immunotherapy in the past one month and inflammatory factor modulators such as Ulinastatin 6. patients who have received organ transplantation or surgery planning in the past 6 months 7. patients who cant take food or drugs due to coma or intestinal obstruction 8.Patients who have severe underlying diseases that affects survival,including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding,severe malnutrition, etc 9.Women subjects that are pregnant or lactating, or subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation) during the study period 10.Allergic to systemic enzyme supplements 11.Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal, or patients with child-Pugh grade C cirrhosis 12.ECLS (ECMO, ECCO2R, RRT) 13.Imminent death in the opinion of the clinical team 14.Patients who have participated in any other clinical study within 2 weeks prior to randomization 15.The investigator concludes that the patient is not suitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients showing clinical improvement.Timepoint: Proportion of patients showing clinical improvement at Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Proportion of patients showing clinical improvement. 2) Time to normalization of fever without use of antipyretics 3) Time to alleviation of cough, fever, dyspnoea, Anosmia and Muscle Pain 4) Time to first negative SARS-CoV-2 RT-PCR in in upper or lower respiratory tract specimen. 5) Duration (days) of supplemental oxygen therapy and Hospitalization. 6) Safety Evaluation and Deaths.Timepoint: 1) Proportion of patients showing clinical improvement.7 Days 2) Time to normalization of fever without use of antipyretics - Upto 21 Days 3) Time to alleviation of cough, fever, dyspnoea, Anosmia and Muscle Pain - Upto 21 Days 4) Time to first negative SARS-CoV-2 RT-PCR in in upper or lower respiratory tract specimen.Upto 21 Days 5) Duration (days) of supplemental oxygen therapy and Hospitalization. Upto 21 Days 6) Safety Evaluation and Deaths.- Upto 21 Days | — |
Countries
India
Contacts
Public ContactDr Rohit Parate
Chirayu Medical College and Hospital
Outcome results
None listed