Clinical trial study to investigate safety and efficacy of ImmunoSEB and ProbioSEB

Not Applicable

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/08/027168
• Lead Sponsor: SRV Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients showing clinical improvementTimepoint: Proportion of patients showing clinical improvement time frame day 14 from the baseline visit

Secondary Outcome Measures

Name	Time	Method
1. Proportion of patients showing clinical improvement [Time Frame: Day 7] <br/ ><br>2. Proportion of patients showing clinical improvement [Time Frame: Day 21] <br/ ><br>3. Time (Days) to clinical improvement [Time Frame: upto 21 days] <br/ ><br>Timepoint: 1. Day 7 <br/ ><br>2.day 21 <br/ ><br>3. upto day 21