Principal Investigator:

Dr. Anupam Prakash,

Professor of Medicine, Lady Hardinge Medical College, New Delhi,

On behalf of the LHMC Medicine COVID-19 Investigator Group

Place of study:

Department of Medicine, Lady Hardinge Medical College and associated Hospitals, New Delhi.

Duration of study: May-October 2020

Type of study: Randomised controlled study.

The world is facing the crisis created by COVID-19, a pandemic of unassumed proportions, which does not have any known treatment yet. Several drugs are being repositioned to see their efficacy for Covid-19. This study is planned to study the efficacy of oral hydroxychloroquine, inhalational ciclesonide and oral ivermectin as treatment option in adult patients (≥18 years) with moderate Covid-19 illness.

Moderate Covid-19 illness will be defined as nasopharyngeal/nasal/oropharyngeal swab positivity by PCR, along with respiratory rate of 15-30/min and SpO2 between 90-94%. Those fitting the inclusion and exclusion criteria, will be enrolled after obtaining an informed written consent, and randomized (by draw of lots) to any of the 4 arms-

(i)            Group A - Hydroxychloroquine 400 mg bid oral Day 1, 200 mg bid on Day 2-7

(ii)          Group B –Ciclesonide 200 mcg bid (through rotahaler) for 7 days

(iii)         Group C –Ivermectin 12 mg orally OD for 7 days

(iv)         Group D –Standard of care only

A sample size of 30 in each arm is proposed to be included over a period of 6 months. A focused physical examination (General appearance and behaviour including mental status, vitals and chest examination) will be performed for each subject enrolled in the study. Routine blood and radiological investigations would be performed for each subject, and an ECG just after admission, and prior to satisfactory discharge. All patients recruited will anyway receive standard of care, and the institutional/national management protocol will be followed in all other respects. Enrolled subjects will be followed up for virologic cure (primary outcome). Repeat PCR testing on fresh swab would be done on Day 6 onwards and two consecutive negative throat swabs at least 24 hours apart would constitute virologic cure (primary outcome). Any positive throat swab on Day 6 onwards, would entail repeat testing after 48 hours. Trial drug would be continued in each group (A, B and C) would be continued for a period of 7 days, though follow-up will be for a period of virologic cure, to a maximum of 14 days. Trial drug would be withdrawn if they deteriorate to severe Covid-19 illness or disseminated intravascular coagulation (DIC) or shock. However, they will be included for the purpose of analysis.

Secondary outcomes include (1) Proportion of patients having resolution of symptoms/signs on Day 7 and Day 14 in each of the groups, (ii) Subjects deteriorating in to severe Covid-19 or developing DIC/shock, (iii) Side-effects observed in each of the group.

The comparative analysis will be performed using ANOVA testing, and the reporting would be done as per CONSORT guidelines.