COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46946

Dr Raghavendra Rao M

ccryn.director@gmail.com

2020-11-03

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1.Covid 19 positive case diagnosed using RT PCR in authorized Covid19 testing facility <br/ >2.Mild clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2, mild 0-4, severe 5-6) <br/ >3.Presenting with or without flu symptoms <br/ >4.Aged 18-60 years <br/ >5.High school education <br/ >6.Written consent to participate in any arm of the study <br/ >7.Those having a smart phone mobile device with android or IOS operating system. <br/ >

1.Severe infection News-3-4 requiring admission to ICU. <br/ >2.Unable to take oral medication, <br/ >3.Immunocompromised, <br/ >4.Creatinine clearance (CCL) < 30 ml/min, <br/ >5.Aspartate transaminase (AST) or alanine transaminase (ALT) > 5 times Upper limit of normal (ULN), <br/ >6.d-dimer > 2microgram per liter, or <br/ >7.Uncontrolled diabetes, Hypertension, Existing Heart disease and heart failure, any cancer, autoimmune disease, stroke, neurodegenerative diseases etc.. <br/ >8.Clinical condition that reduces survival to less than six months. <br/ >9.Pregnancy and lactating mothers <br/ >10.Clinical signs suggestive of septicemia and multi organ dysfunction. <br/ >11. Score of less than 24 points on the Folstein Mini-Mental State Examination(43). <br/ >12.Score of more than 14 points on the 9-item Patient Health Questionnaire (PHQ-9) depression screen (44). <br/ >13.BMI less than 18 <br/ >

2

Central Council for Research in Yoga and Naturopathy Ministry of AYUSH

18

60

India

Mild disease at enrollment

1: Mild disease at enrollment

86

The primary outcome will be defined as area-under-the curve global severity for all ARI illness days throughout observation; from consent to study exitTimepoint: Day 0 to study exit

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

Not reported

[{"arm_notes": "", "treatment_id": 1109, "treatment_name": "Respiratory exercises", "treatment_type": "Rehabilitation", "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"}]