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 days
Control Intervention1: Standard Care: stand
Sponsors
SRV Hospital
SRV Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient who provides written informed consent 2.Male or non-pregnant, non-lactating female aged � 18 and � 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 �93% in rest state 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 tha 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 15.15. The investigator concludes that the patient is not suitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients showing clinical improvementTimepoint: Proportion of patients showing clinical improvement time frame day 14 from the baseline visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients showing clinical improvement [Time Frame: Day 7] 2. Proportion of patients showing clinical improvement [Time Frame: Day 21] 3. Time (Days) to clinical improvement [Time Frame: upto 21 days] Timepoint: 1. Day 7 2.day 21 3. upto day 21 | — |
Countries
India
Contacts
Public ContactDr Abhay Vispute Shantaram
SRV Hospital
Outcome results
None listed