Health Condition 1: B338- Other specified viral diseases
Conditions
Interventions
Intervention1: Budesonide dry powder inhaler: 400 mcg budesonide inhaler. Two puffs twice a day up to twenty eight days
Control Intervention1: Usual care: Care of COVID-19 as per local guidelines
Sponsors
YOU BREATHE WE CARE
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participant is willing and able to give informed consent 2.Male or Female aged 18 years or above 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 4.Able and willing to comply with all trial requirements as per Investigator
Exclusion criteria
Exclusion criteria: 1.A known allergy to IMP 2. Any known contraindication to IMP 3. Patient currently prescribed inhaled or systemic corticosteroids 4.Recent use, within the previous 7 days of inhaled or systemic corticosteroids 5. Patient needs hospitalisation at time of study consent 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 participant’s ability to participate in the trial. 7. Participants who have participated in another research trial involving an investigational product in the past 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospitalisation or emergency department attendance related to COVIDTimepoint: Day zero to day twenty eight | — |
Secondary
| Measure | Time frame |
|---|---|
| Body temperature Timepoint: Day zero to day twenty eight;Blood oxygen saturation levelTimepoint: Day zero to day twenty eight;Common cold questionnaireTimepoint: Day zero to day twenty eight;FluPRO questionnaireTimepoint: Day zero to day twenty eight;Nasal /throat swabTimepoint: Day 0, Day 7-9 | — |
Countries
India
Contacts
Public ContactDr Raja Dhar
Outcome results
None listed