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
|
|
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
|
|
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. | |