| CTRI Number |
CTRI/2020/09/027944 [Registered on: 22/09/2020] Trial Registered Prospectively |
| Last Modified On: |
21/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An open label, prospective comparative study to evaluate the proposed therapy in adults with mild symptomatic COVID-19 patients receiving the standard treatment of COVID infection. |
|
Scientific Title of Study
|
An open label, prospective comparative study to evaluate potential of the proposed therapy (Tablet Cefixime 200 mg/Tablet Ivermectin 12 mg/Tablet Montelukast 10mg/Syrup Ascoril LS 5 ml) in adults with mild symptomatic COVID-19 patients receiving the standard treatment (Tablet Cefixime 200 mg/Vitamin C, MVBC/Antacids) of COVID infection. |
| Trial Acronym |
Add on therapy/COVID-19/2020 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anita Saibannavar |
| Designation |
M.B.B.S., M.D. (Pulmonary Medicine) |
| Affiliation |
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College & CPR Hospital, Kolhapur |
| Address |
Pulmonary Department
CPR Hospital Bhausinghaji Road, Dasara Chowk,Kolhapur, Maharashtra, INDIA.
Kolhapur
MAHARASHTRA
416002
India |
| Phone |
7775014777 |
| Fax |
|
| Email |
dr.saibannavar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhananjay Lad |
| Designation |
Director & Owner |
| Affiliation |
CROM Clinical Research & Medical Tourism Pvt. Ltd. |
| Address |
CROM Premises Department, Building no. 2, Opp. Caculo Mall, St. Inez, Panaji
North Goa
GOA
4033001
India |
| Phone |
9158592177 |
| Fax |
|
| Email |
laddhl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhananjay Lad |
| Designation |
Director & Owner |
| Affiliation |
CROM Clinical Research & Medical Tourism Pvt. Ltd. |
| Address |
CROM Premises Department, Building no. 2, Opp. Caculo Mall, St. Inez, Panaji
North Goa
GOA
4033001
India |
| Phone |
9158592177 |
| Fax |
|
| Email |
laddhl@gmail.com |
|
|
Source of Monetary or Material Support
|
| Public Health Department, Central Building, Bavada Kolhapur, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Public Health Department |
| Address |
Kolhapur, Maharashtra |
| Type of Sponsor |
Other [Government Heath Department] |
|
|
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 Anita Saibannavar |
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College & CPR Hospital, Kolhapur |
Pulmonary Department CPR Hospital Bhausinghaji Road, Dasara Chowk,Kolhapur, Maharashtra, INDIA.
Kolhapur
MAHARASHTRA |
7775014777
dr.saibaanavar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarshee Chhatrapati Shahu Maharaj Government Medical College, Chhatrapati Pramila Raje General Hospital Kolhapur Institutional Ethics Committee II, (RCSMGMCIEC II),Kolhapur. |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tab.Cefixime 200 mg
Tab.Ivermectin 12 mg
Tab.Montelukast 10 mg
Syp.Ascoril LS 5 ml |
Tab.Cefixime 200 mg BD for 5 days
Tab.Ivermectin 12 mg OD for day 1
Tab.Montelukast 10 mg OD for 5 days
Syp.Ascoril LS 5 ml for 3 times a day for 5 days |
| Comparator Agent |
Tablet Cefixime 200 mg
Vitamin C, MVBC, Antacids |
Tablet Cefixime 200 mg BD for 5 days
Vitamin C, MVBC, Antacids (Pantoprazole 40 mg) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both Gender aged more than 18 years old.
2.Willing and able to provide written informed consent.
3.Patients with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV2 / COVID) infection confirmed by RT Polymerase chain reaction (RT-PCR) test
4.Currently hospitalized and requiring medical care for COVID-19
5.Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
|
|
| ExclusionCriteria |
| Details |
1.Subjects having less than 18 years of age
2.Drug atopy subjects
3.Private positive patients/ Truenaat positive/ Antigen positive
4.Critical comorbities |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compared to standard of treatment receiving in COVID -19 infection, proposed regimen if consumed as an add on therapy prescribed by physician as per the clinical conditions and disease outcome will be efficacious in reducing medically attended lung infection caused by RT-PCR-confirmed COVID-19 virus in COVID Positive adults more than age 18 yrs . |
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
There will be a reduction in the incidence of hospitalizations attributable to COVID-19 in patients treated with proposed regimen
There will be minimal chances of respiratory failure in patients due to COVID-19 in patients treated with proposed regimen
|
14 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/09/2020 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
population of adult patients more than the the age of 18 yrs admitted to a
hospital or in Quarantine setup with symptoms suggestive of COVID-19 infection
shall be screened for the study. PCR positive in
sample collected < 96 hours prior to randomization; OR PCR positive in
sample collected >/= 96 hours prior to randomization, documented inability
to obtain a repeat sample (e.g. due to lack of testing supplies, limited
testing capacity, results taking >24 hours, or any documented reason etc.)
AND progressive disease suggestive of ongoing SARS-CoV-2 infection shall be
considered as important criteria for enrollment in the study. |