COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48544

Dr Raja Dhar

pulmoresearch@gmail.com

2021-05-27

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1.Participant is willing and able to give informed consent <br/ >2.Male or Female aged 18 years or above <br/ >3.New onset of symptoms suggestive of COVID19 like new onset cough fever, loss of smell or taste within 7 or fewer days of participant being seen at visit 1 <br/ >4.Able and willing to comply with all trial requirements as per Investigator

1.A known allergy to IMP <br/ >2. Any known contraindication to IMP <br/ >3. Patient currently prescribed inhaled or systemic corticosteroids <br/ >4.Recent use, within the previous 7 days of inhaled or systemic corticosteroids <br/ >5. Patient needs hospitalisation at time of study consent <br/ >6. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participantâ??s ability to participate in the trial. <br/ >7. Participants who have participated in another research trial involving an investigational product in the past 12 weeks

2

YOU BREATHE WE CARE

18

99

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

820

Hospitalisation or emergency department attendance related to COVIDTimepoint: Day zero to day twenty eight

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

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 242, "treatment_name": "Budesonide", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]