COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59357

Dr Ayush Agarwal

doctoranimeshray@gmail.com

2021-08-17

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

a) Aged at least 18 years <br/ >b) Hospitalised <br/ >c) Confirmed SARS-CoV-2 infection by nucleic acid based testing (RT-PCR, CB-NAAT, or TrueNAT) or antigen testing <br/ >d) Moderate and severe COVID-19 pneumonia (SpO2 <94%) <br/ >e) Decreasing supplemental oxygen requirements (Nasal prongs â?¤6 L/min) <br/ >f) Hemodynamically stable <br/ >g) Cooperative <br/ >h) No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial <br/ >

a) MMSE <24 <br/ >b) Recent surgery, cardiovascular event (ACS, PE) <br/ >c) Moderate-severe heart disease (NYHA grade III or IV) <br/ >d) CLD with ascites <br/ >e) Prior history of TB, COPD, asthma, ILD <br/ >f) Pregnant and lactating women <br/ >g) Difficulty in mobilisation (for 6MWT) <br/ >h) Hemodynamically unstable <br/ >i) Refusal of consent

3

Dr Animesh Ray

18

99

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

75

Degree of improvement in respiratory parameters as measured by S. George Respiratory questionnaire (SGRQ); 6 minute walk test (6MWT); mMRC dyspnea scale and single breath count.Timepoint: At discharge; 2 weeks; 1 month and 3 months

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

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1894, "treatment_name": "Volume oriented spirometer", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1893, "treatment_name": "Flow oriented spirometer", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 388, "treatment_name": "Deep breathing exercise", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}]