Summary of Protocol

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-July 2020

Type of study: Randomised Controlled Trial

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. Niclosamide has been reported to have excellent in vitro antiviral activity but has yet not been tested in diseased humans. This study is planned to study the efficacy of oral niclosamide as treatment option in adult patients (≥18 years) with mild and very mild Covid-19 illness.

Mild/presymptomatic Covid-19 illness will be defined as nasopharyngeal/nasal/oropharyngeal swab positivity for nCoV-2019 by PCR, along with respiratory rate of 12-18/min and SpO2 ≥95% and no clinico-radiological signs of pneumonia. Those fitting the inclusion and exclusion criteria, will be enrolled after obtaining an informed written consent, and randomized (by draw of lots) to either of the 3 arms-

(i)            Group A – Standard of care only (n=30)

(ii)          Group B –Niclosamide 500 mg oral bid for a period of 7 days (n=30)

(iii)         Group C –Niclosamide 1000 mg bid for a period of 7 days (n=30)

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 after admission, and prior to satisfactory discharge. All patients recruited will be receiving the 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 Day 6 onwards and two consecutive negative throat swabs at least 24 hours apart would constitute virologic cure (primary outcome). A positive throat swab Day 6 or thereafter, would entail repeat testing after 48 hours. Trial drug would be continued till virologic cure (minimum duration of therapy 7 days). Trial drug would be withdrawn if enrolled subjects do not achieve virologic cure by Day 14 or if they deteriorate in to severe Covid-19 illness or DIC or shock.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 3 and Day 5, in each of the groups, (ii) Proportion of subjects deteriorating to moderate or severe Covid-19, (iii) Adverse effects noted in each of the group.

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