| CTRI Number |
CTRI/2020/08/027282 [Registered on: 20/08/2020] Trial Registered Prospectively |
| Last Modified On: |
19/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Prophylactic Ivermectin in COVID 19 Contacts |
|
Scientific Title of Study
|
Effectiveness of Ivermectin in preventing development of symptomatic Covid-19 among primary contacts of newly diagnosed Covid-19 positive patients at a tertiary care hospital in North India - an interventional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rambha Pathak |
| Designation |
Dean Prof. and head |
| Affiliation |
Govt Institute of Medical Sciences |
| Address |
Room no. 135
Deans office
Government Institute of Medical Sciences
Greater Noida
UP
Gautam Buddha Nagar
UTTAR PRADESH
201312
India |
| Phone |
8826843180 |
| Fax |
|
| Email |
rambha_p@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Srivastava |
| Designation |
Prof. & Head, Dept. of Medicine |
| Affiliation |
Govt Institute of Medical Sciences |
| Address |
Room No.101
Department of Medicine
Government Institute of Medical Sciences
Greater Noida
UP
Gautam Buddha Nagar
UTTAR PRADESH
201312
India |
| Phone |
|
| Fax |
|
| Email |
saurabhsrivas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hariom Kumar Solanki |
| Designation |
Assistant Professor |
| Affiliation |
Govt Institute of Medical Sciences |
| Address |
Room no. 401
Department of Community Medicine
Government Institute of Medical Sciences
Greater Noida
UP
Gautam Buddha Nagar
UTTAR PRADESH
201312
India |
| Phone |
|
| Fax |
|
| Email |
hariom.mamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Director
Government Institute of Medical Sciences
Greater Noida
Gautam Budh Nagar
Uttar Pradesh 201310 |
|
|
Primary Sponsor
|
| Name |
Department of Community Medicine |
| Address |
Govt. Institute of Medical Sciences
Greater Noida
Gautam Budh Nagar
Uttar Pradesh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rakesh Gupta |
Govt. Institute of Medical Sciences
Greater Noida
UP |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rambha Pathak |
Government Institute of Medical Sciences |
Room no. 135
Dept. of Community Medicine Govt Institute of Medical Sciences
Greater Noida
UP
Gautam Buddha Nagar
UTTAR PRADESH |
08826843180
rambha_p@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy contact of COVID 19 Patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ivermectin 12mg or Ivermectin 36mg single dose orally once only |
The study will have two intervention arms.
In the intervention Arm 1: 12mg oral Ivermectin will be given to the close family contacts fulfilling the inclusion- exclusion criteria for this study; of the newly diagnosed Covid-19 patient within 24 hours of diagnosis. The drug will be given orally and once only (under supervision).
In the intervention Arm 2: 36 mg oral Ivermectin will be given to the close family contacts fulfilling the inclusion- exclusion criteria for this study; of the newly diagnosed Covid-19 patient within 24 hours of diagnosis. The drug will be given orally and once only (under supervision). |
| Comparator Agent |
Two Multivitamin tablets |
In the control group - each participant will be given 2 (two) multivitamin tablets (available in the supply at the study institute). These tablets will be given orally, under-supervision and only once. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All the family members of a newly diagnosed Covid-19 patient who are - living with the patient in the last 2 weeks, aged between 18 years and 60 years of age, asymptomatic on the day of diagnosis of the index case. |
|
| ExclusionCriteria |
| Details |
The following will be excluded from the study:
1. Pregnant or lactating women
2. Those with any degree of ARI symptoms or fever.
3. Person with known history of severe hypersensitivity reaction to previous exposure to Ivermectin.
4. People with pre-existng severe medical conditions according to the judgement of
the investigators |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptomatic Covid-19 among the study participants |
Between 7 and 10 days of Ivermectin intake |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects of Ivermectin experienced by the study participants |
On the day of Ivermectin intake and between 7 and 10 days of Ivermectin intake |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 3 |
|
Date of First Enrollment (India)
|
31/08/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. Şimşek Yavuz S, Ünal S. Antiviral treatment of COVID-19. Turk J
Med Sci. 2020;50(SI-1):611-619. Published 2020 Apr 21.
doi:10.3906/sag-2004-145.
2. Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDAapproved
drug ivermectin inhibits the replication of SARS-CoV-2
in vitro. Antiviral Res. 2020. https://doi.org/
10.1016/j.antiviral.2020.104787
3. Patrì A, Fabbrocini G. Hydroxychloroquine and ivermectin: A
synergistic combination for COVID-19 chemoprophylaxis and
treatment?. J Am Acad Dermatol. 2020;82(6):e221.
doi:10.1016/j.jaad.2020.04.017.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Effective medical prophylaxis can help in curbing the transmission of COVID 19. Ivermectin has been found to be having antiviral properties against SARS-COV-2 virus and trials have been started in various parts of the world to study the effectiveness of Ivermectin as a post exposure prophylaxis of COVID 19. Keeping this in view an attempt is being made in the study to determine the effectiveness of single-dose ivermectin 12mg or 36mg in reducing the probability of contracting the infection from positive household contacts in India. |