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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: 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 |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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. |