COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48811

Dr Upendra Hansda

uhansdah@gmail.com

2020-12-18

Recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

Suspected (presenting with dyspnea, fever, cough) or confirmed COVID-19 positive having SpO2 â?¥90% with FiO2 â?¤0.6.

Patients who are suspected or confirmed COVID-19 and <br/ >a. Not able to follow commands and prone by self <br/ >b. Intestinal obstruction/perforation <br/ >c. Recent abdominal or thoracic surgery <br/ >d. Hemodynamically unstable (SBP <90, HR >120) <br/ >e. Physical habitus not permitting prone position <br/ >f. Pregnancy ( >20 weeks) <br/ >g. Unstable spine or unstable fracture <br/ >h. Respiratory distress with use of accessory respiratory muscles <br/ >i. SpO2 <90% with FiO2 of â?¥0.6 ( <90% with non-rebreather mask and respiratory rate >30) <br/ >j. Patients on ventilator support <br/ >

2

Dr Upendra Hansda

18

80

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

190

Requirement of ventilatory supportTimepoint: Day 1; Day 2; Day 3; Day 4; Day 5; Day 6; Day 7; Day 8; Day 9; Day 10.

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

Not reported

[{"arm_notes": "", "treatment_id": 1027, "treatment_name": "Prone position", "treatment_type": "Respiratory support", "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"}]