COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54949

Mukul Maurya

rohitparate963@gmail.com

2021-05-12

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Long covid

Inclusion Criteria: <br/ > Subjects will be included in the study if they meet all of the following criteria: <br/ >1.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 at any time followed by an RT-PCR negative test <br/ >4.Patients who are experiencing fatigue and muscle weakness <br/ >5.Able to take the drug orally and comply with study procedures <br/ >6.Women of childbearing potential must have a negative urine pregnancy test prior to study entry

EXCLUSION CRITERIA <br/ >Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria: <br/ >1.Patients with severe to critical type of health condition as stratified below: <br/ >2.Clinical stratification: <br/ >3.Severe type: meeting any of the following criteria: <br/ >(a)Respiratory distress, RRâ?¥30 times/min <br/ >(b)Finger oxygen saturation â?¤90% in resting state <br/ >(c)Arterial partial pressure of oxygen (PaO2)/concentration of oxygen inhalation (FiO2)â?¤300mmHg. <br/ >4.Critical type: meeting any of the following criteria: <br/ >(a)Respiratory failure occurs and mechanical ventilation is required, <br/ >(b)Patients go into shock, <br/ >(c) ICU is needed for other organ failure. <br/ >5.Other viral pneumonia Patients who can not take food or drugs due to coma or intestinal obstruction <br/ >6.Consumption of other oral probiotic supplements during the trial <br/ >7.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/ >8.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/ >9.Allergic to systemic enzyme supplements. <br/ >10.Imminent death in the opinion of the clinical team <br/ >11.Patients with Hb less than 8 mg/dl <br/ >13.Patients who have participated in any other clinical study within 2 weeks prior to randomization, <br/ >14.The investigator concludes that the patient is not suitable for the study. <br/ >

2

Advanced Enzyme Technologies Ltd

18

75

India

Patients recovered from covid

N/A

200

1.Proportion of patients showing improvement on Chalder Fatigue Scale. <br/ >2. Proportion of patients showing Improvement in mental Fatigue on CFQ.Timepoint: 1.Proportion of patients showing improvement in physical Fatigue on CFQ [Time Frame: Day 14] <br/ >2.Proportion of patients showing Improvement in mental Fatigue on CFQ [Time Frame: Day 14] <br/ >

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

Phase 2

[{"arm_notes": "", "treatment_id": 2226, "treatment_name": "Immunoseb+probioseb csc3", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]