COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48223

Pragya Jain Shrimal

trisatyapriya77@gmail.com

2020-10-20

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1) Only COVID-19 positives confirmed by RT-PCR method to be recruited. <br/ >2)Patients who are affected by the coronavirus (COVID-19) and are in hospital confinement. <br/ >3) Patients with mild symptoms which may include: uncomplicated upper respiratory tract viral infection symptoms such as fever, fatigue, cough (with or without sputum production), anorexia, malaise, muscle pain, sore throat, dyspnoea, nasal congestion, or headache. <br/ >4)Inclusion of symptomatic patients. <br/ >

1) Unwilling for participation. <br/ >2) Physical and mental disability. <br/ >3) Medical restriction for physical movement. <br/ >4) History of recent surgery. <br/ >5) Patients with Pneumonia, Acute Respiratory Distress Syndrome (ARDS) & patients admitted in Intensive Care Units (ICU). <br/ >6) Pregnant females. <br/ >7) Patients with severe co-morbid conditions (Congestive Heart failure, Uncontrolled Diabetes, Renal failure on hemodialysis, Cancer patients).

2

Pragya Jain Shrimal

18

80

India

Mild disease at enrollment

1: Mild disease at enrollment

50

Oxygen Saturation; Heart Rate; Respiratory Rate and Blood pressure <br/ >Timepoint: Day 5th and Day 6th <br/ >

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 1

[{"arm_notes": "", "treatment_id": 987, "treatment_name": "Physical 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"}]