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CTRI Number  CTRI/2021/10/037502 [Registered on: 22/10/2021] Trial Registered Prospectively
Last Modified On: 24/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Use of Ambroxol in patients with moderate COVID-19 disease. 
Scientific Title of Study   A randomized, placebo controlled, double-blind study to evaluate the safety and efficacy of oral Ambroxol in hospitalized patients with COVID-19 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milind Nadkar 
Designation  Professor and Head, Dept. of Medicine 
Affiliation  Seth GS Medical College & KEM Hospital, Parel, Mumbai-400012 
Address  Department of Medicine, 2nd Floor, Hospital Building, Seth G.S.Medical College and K.E.M.Hospital, Acharya Dhonde Marg,Parel,Mumbai-400012,India.

Mumbai
MAHARASHTRA
400012
India 
Phone  9820060705  
Fax    
Email  milindnadkar@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nithya Gogtay 
Designation  Professor and Head, Department of Clinical Pharmacology 
Affiliation  Seth GS Medical College & KEM Hospital, Parel, Mumbai-400012 
Address  Dept. of Clinical Pharmacology 1st Floor, New Building Seth GSMC & KEM Hospital Parel. Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9820495836  
Fax    
Email  njgogtay@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nithya Gogtay 
Designation  Professor and Head, Department of Clinical Pharmacology 
Affiliation  Seth GS Medical College & KEM Hospital, Parel, Mumbai-400012 
Address  Dept. of Clinical Pharmacology 1st Floor, New Building Seth GSMC & KEM Hospital Parel. Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9820495836  
Fax    
Email  njgogtay@hotmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research-Product Development Centre 
 
Primary Sponsor  
Name  ICMR 
Address  Indian Council of Medical Research. V. Ramalingaswami Bhawan, P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029, India. 
Type of Sponsor  Government funding agency 
 
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 Milind Nadkar  Seth G.S.M.C and K.E.M Hospital Mumbai  Department of Medicine, Hospital Building, Seth G.S.Medical College and K.E.M.Hospital, Acharya Dhonde Marg, Parel, Mumbai-400 012, India.
Mumbai
MAHARASHTRA 
9820060705

milindnadkar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Ethics Committee I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Ambroxol 30 mg two tablets  Ambroxol 30 mg two tablets TDS for 14 days or till discharge whichever is earlier with Standard of care 
Comparator Agent  Matching Placebo  Matching Placebo 2 tablets TDS for 14 days or till discharge whichever is earlier with Standard of care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Participants who are able to provide a written informed consent or have a legally accepted representative to provide the same.
Participants who are between 18 years and 75 years of age.
Participants who are proven to be positive for SARS-CoV-2 infection, as confirmed by the RT-PCR test.
Participants who are admitted with moderate COVID-19 for treatment at the hospital.
Female participants with a negative urine pregnancy test at screening.
Participants who are able to take the study drug orally and comply with the study procedures.
 
 
ExclusionCriteria 
Details  Participants who are participating in any other clinical trial or experimental treatment for COVID-19.

Participants with pre-existing respiratory illness.

Participants with persistent vomiting (more than three episodes of vomiting in 12 hours) and who cannot tolerate oral drugs.

Participants requiring concomitant use of invasive or non-invasive mechanical ventilation.

Participants requiring vasopressors or ionotropic medications.

Female Participants who are lactating.

Participants who are known to be HIV positive or positive for Hepatitis B or C. (The same may be noted based on history given by the subject or standards of care followed at the individual sites.)

Participants who are not deemed fit as per the investigator or his/her team for any other medical reason.

Past history of allergy to Ambroxol.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Proportion of patients showing clinical improvement: Clinical improvement is defined as the patients meeting the discharge criteria or a 2-point improvement in the disease severity on the 8-point ordinal scale. Discharge criteria includes resolution of clinical symptoms, biochemical tests or radiological improvement, as per discretion of the Investigator.  Timepoints: Baseline, day 1, day 3, day 5, day 7 and day 10 or at discharge, whichever is earlier.
(In case the patient is admitted beyond day 10, the scale will be administered till day 10 as per the above-mentioned schedule and again at discharge.)
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Overall survival of the subjects: [Time Frame: 14 days]: 14-Day Overall Survival is defined as the status of the subject at the end of 14 days, beginning from the time of study in both the treatment groups.



Proportion of patients with progression of COVID-19 associated pneumonitis



Number of Intensive care unit (ICU) days  
14 days after study entry







Up to 14 days after study entry




Up to 14 days after study entry









 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   31/10/2021 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  


    This randomized, placebo controlled, double blind study comparing safety and efficacy of Ambroxol with current standard of care versus Placebo and standard of care in hospitalized patients with moderate COVID-19 will be conducted for a duration of 6 months at the Department of Clinical Pharmacology in collaboration with Department of Medicine, Seth GSMC and KEMH, Mumbai only after Ethics Committee approval. Patients who are diagnosed to have COVID -19 per RT PCR and admitted with moderate COVID-19. Based on eligibility criteria, they will be screened, counselled and enrolled in the study. A total of 60 patients (30 in Ambroxol group and 30 in Placebo group) will be recruited. They will be randomized by Sequentially Numbered Opaque Sealed Envelope (SNOSE) technique with an allocation of 1:1 maintained for both groups. A pre-designed case record from will be used to capture all the relevant parameters during the study. Chest X ray will be performed at the baseline and again before the discharge. In Group A: 30 patients will be given Tablet Ambroxol 60 mg orally TDS till discharge or for 14 days whichever is earlier along with SOC. In Group B: 30 patients will be given matching placebo tablets + SOC till discharge or for 14 days whichever is earlier. They will be evaluated for proportion of patients showing clinical improvement, time to clinical improvement and overall survival of patients. A Clinical Improvement Scale [ordinal 8-point scale ( Ranging from ambulatory to death and acknowledges the severity of illness over time] will be administered at baseline, day 1, day 3, day 5, day 7 and day 10 or at discharge, whichever is earlier. In case the patient is admitted beyond day 10, the scale will be administered till day 10 as per the above-mentioned schedule and again at discharge.


 
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