FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/04/024949 [Registered on: 30/04/2020] Trial Registered Prospectively
Last Modified On: 27/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to evaluate the effect of Oral Niclosamide in mild and very mild COVID-19 cases 
Scientific Title of Study   EFFICACY OF ORAL NICLOSAMIDE IN TREATMENT OF MILD AND VERY MILD COVID-19 CASES: AN OPEN-LABEL RANDOMIZED CONTROLLED TRIAL 
Trial Acronym  EONIC-COVID 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anupam Prakash 
Designation  Professor 
Affiliation  LADY HARDINGE MEDICAL COLLEGE 
Address  DEPARTMENT OF MEDICINE, SHAHEED BHAGAT SINGH MARG, NEW DELHI-110001

New Delhi
DELHI
110001
India 
Phone  8588885305  
Fax    
Email  prakashanupam@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anupam Prakash 
Designation  Professor 
Affiliation  LADY HARDINGE MEDICAL COLLEGE 
Address  DEPARTMENT OF MEDICINE, SHAHEED BHAGAT SINGH MARG, NEW DELHI-110001

New Delhi
DELHI
110001
India 
Phone  8588885305  
Fax    
Email  prakashanupam@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Anupam Prakash 
Designation  Professor 
Affiliation  LADY HARDINGE MEDICAL COLLEGE 
Address  DEPARTMENT OF MEDICINE, SHAHEED BHAGAT SINGH MARG, NEW DELHI-110001

New Delhi
DELHI
110001
India 
Phone  8588885305  
Fax    
Email  prakashanupam@hotmail.com  
 
Source of Monetary or Material Support  
Dr Anupam Prakash Professor Room No 1014 Department of Medicine Smt Sucheta Kriplani Marg Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi 110001 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Shaheed Bhagat Singh Marg New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anupam Prakash  Lady Hardinge Medical College  Shaheed Bhagat Singh Marg New Delhi
New Delhi
DELHI 
8588885305

prakashanupam@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Lady Hardinge Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere, B338||Other specified viral diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Niclosamide  500 mg bid for 7-14 days 
Comparator Agent  Standard of care  As per MoHFW, GoI guidelines 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  • Adult patients (≥18years) suffering from mild or very mild Covid-19 (8). A positive throat swab for nCoV-2019 (by real time PCR) obtained from a patient suspected to be Covid-19 or from a contact (or HCW) of Covid-19 patient will be considered to be a Covid-19 case, irrespective of the presence of symptoms. Mild disease will be defined as respiratory rate between 12-18/minute and SpO2 ≥ 95% in room air and no clinico-radiological (normal chest X-ray) signs of pneumonia. 
 
ExclusionCriteria 
Details  • Patients with renal or hepatic dysfunction (Serum creatinine > 1.5 mg/dL and serum transaminase levels >120 U/L)
• Patients with clinical heart failure/known CAD
• Known cases of neoplasms or immunodeficiency syndromes
• Patients who are on chemotherapy, immunosuppressive agents, steroids or antiviral agents, or have received in the preceding 4 weeks
• Pregnant and lactating patients
• Uncooperative patients (in the opinion of the investigator, if it is difficult to ensure patient cooperation during the study)
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients having virologic cure on Day 6 in both the groups  Day 6 of treatment initiation 
 
Secondary Outcome  
Outcome  TimePoints 
o Proportion of patients having resolution of symptoms on Day 7 and Day 14 in both the groups
o The individual proportion of aforementioned rescue criteria in both the groups.
o Side-effects (adverse events) noted in both the groups
 
7 and 14 days 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/05/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Brief Summary
Modification(s)  

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.

 
Close