COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57135

Soumya Umesh

drsoumya239@gmail.com

2021-06-22

Not recruiting

RCT

Randomized

Cluster

Open label

single-center

Treatment

CONSENTING COVID 19 PATIENTS HOSPITALISED FOR MILD,MODERATE,SEVERE DISEASE

1. Inability to prone due to mechanical reasons <br/ >2. Heart failure NYHA Class 3/4 <br/ >3. Decompensated Chronic Liver Disease with ascites <br/ >4. Presence of Pneumothorax or Pneumomediastinum <br/ >5. Critically Ill patients <br/ >6. Intubated patients <br/ >7. Morbid obesity <br/ >8. Pregnancy <br/ >9. Unstable Fractures <br/ >10. Acute Hypercapnic respiratory failure <br/ >11. Deep Vein Thrombosis (untreated <48hrs) <br/ >12. Other contraindications to Prone position documented in the Case record by the treating physician. <br/ >13. Intervention delayed beyond 48 hours of admission. <br/ > <br/ >

2

NONE

18

90

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

302

Need for invasive or non invasive ventilation or the occurence of death.Timepoint: At baseline; then daily till 7 days in both arms. After this all patients will be followed up till discharge or death. Final outcome will be recorded at that time.

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

Not reported

[{"arm_notes": "", "treatment_id": 1884, "treatment_name": "Multi-component educational intervention on proning man\u0153uvre", "treatment_type": "Education", "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"}]