COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45750

Dr Abhay Vispute Shantaram

drasv.surgiciansrv@gmail.com

2020-08-14

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1.Patient who provides written informed consent <br/ >2.Male or non-pregnant, non-lactating female aged â?¥ 18 and â?¤ 75 years (both inclusive) <br/ >3.RT-PCR confirmed diagnosis of COVID-19 <br/ >4.Able to take the drug orally and comply with study procedures <br/ >5.Women of childbearing potential must have a negative urine pregnancy test prior to study entry <br/ > <br/ >

1. Severe Type <br/ >Respiratory distress, RRâ?¥30 times/min <br/ >Finger oxygen saturation â?¤93% in rest state <br/ >Arterial partial pressure of oxygen (PaO2)/concentration of oxygen inhalation FiO2 â?¤300mmHg <br/ >2. Critical type: meeting any of the following criteria <br/ >Respiratory failure occurs and mechanical ventilation is required <br/ >Patients go into shock <br/ >ICU is needed for other organ failure. <br/ >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. <br/ >4.other viral pneumonia <br/ >5.patients who have received tumor immunotherapy in tha past one month and inflammatory factor modulators such as Ulinastatin <br/ >6. patients who have received organ transplantation or surgery planning in the past 6 months <br/ >7. patients who cant take food or drugs due to coma or intestinal obstruction <br/ >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 <br/ >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 <br/ >10.Allergic to systemic enzyme supplements <br/ >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 <br/ >12.ECLS (ECMO, ECCO2R, RRT) <br/ >13.Imminent death in the opinion of the clinical team <br/ >14.Patients who have participated in any other clinical study within 2 weeks prior to randomization <br/ >15.15. The investigator concludes that the patient is not suitable for the study <br/ >

2

SRV Hospital

18

75

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

60

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

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 2226, "treatment_name": "Immunoseb+probioseb csc3", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]