CTRI/2020/04/024948.

Study name	Efficacy of hydroxychloroquine, ciclesonide and ivermectin in treatment of moderate COVID‐19 illness: an open‐label randomised controlled study
Methods	Trial design: randomised, parallel‐group trial Sample size: 120 Setting: inpatient Language: English Number of centres: 1 Type of intervention: treatment
Participants	Inclusion criteria: adults (aged > 18 years) with COVID‐19 positive throat swab (by real‐time PCR) obtained from a patient suspected to be COVID‐19 or from a contact (or healthcare worker) of person with COVID‐19 will be considered to be a COVID‐19 case presence of moderate COVID‐19 as defined by the presence of pneumonia (clinical and radiological signs) with a respiratory rate 15–30/minute or oxygen saturation 90–94% on room air, or both Exclusion criteria: people with renal or hepatic dysfunction (serum creatinine > 1.5 mg/dL and serum transaminase levels > 120 U/L) people with clinical heart failure/known coronary artery disease known cases of neoplasms or immunodeficiency syndromes people receiving chemotherapy, immunosuppressive agents, steroids or antiviral agents, or have received in the preceding 4 weeks pregnant and lactating women unco‐operative people (in the opinion of the investigator)
Interventions	Intervention group: inhaled ciclesonide 200 μg twice daily for 7 days Control group: supportive management as per national guidelines Concomitant therapy: no
Outcomes	Primary outcome: proportion of people having virological cure on day 6 of treatment initiation Secondary outcomes: proportion of people with resolution of symptoms/signs on days 7 and 14; proportion of rescue criteria on days 7 and 14; adverse effects on days 7 and 14
Starting date	15 May 2020
Contact information	Anupam Prakash Department of Medicine Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi 110001 India prakashanupam@hotmail.com
Notes	Recruitment status: not yet recruiting Prospective completion date: not reported Date last update was posted: 30 April 2020 Sponsor/funding: Lady Hardinge Medical College