CTRI Number |
CTRI/2020/08/027005 [Registered on: 05/08/2020] Trial Registered Prospectively |
Last Modified On: |
10/08/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Homeopathy |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Investigation of effect of homoeopathic remedy as add on therapy to standard of care (regular treatment) in adult patients with moderate to severe COVID-19 |
Scientific Title of Study
|
A Phase 2 evaluation of the efficacy of homoeopathic remedy Zincum Muriaticum as an adjuvant therapy to standard of care in adult patients with moderate to severe COVID-19: Randomized, double-blind, parallel group, placebo controlled, multicenter trial (ZIMCOV) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Anil Habbu |
Designation |
Col (Hony) |
Affiliation |
Homoeocon Foundation |
Address |
B-5 Abhimanshree Society, Pashan road, Pune
Pune MAHARASHTRA 411008 India |
Phone |
020-25658688 |
Fax |
|
Email |
drahabbu@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anil Khurana |
Designation |
Director General Incharge |
Affiliation |
Central Council for Research in Homoeopathy |
Address |
61-65 Institutional Area, Opp D Block, Janak Puri, New Delhi
New Delhi DELHI 110058 India |
Phone |
011-28525523 |
Fax |
011-28521060 |
Email |
ccrhindia@gmail.com |
|
Details of Contact Person Public Query
Modification(s)
|
Name |
Dr Amitvikram Habbu |
Designation |
Director |
Affiliation |
Homeocon Foundation |
Address |
B-5 Abhimanshree society, Pashan road, Pune, Maharashtra-411008.
Pune MAHARASHTRA 411008 India |
Phone |
020-25658688 |
Fax |
|
Email |
dramithabbu@gmail.com |
|
Source of Monetary or Material Support
|
Homoeocon Foundation, B-5 Abhimanshree Society, Pashan road, Pune-411008, Maharashtra |
|
Primary Sponsor
|
Name |
Homoeocon Foundation |
Address |
Homoeocon Foundation,
B-5 Abhimanshree Society, Pashan road, Pune-411008
|
Type of Sponsor |
Other [Non-Profit Organization] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 3 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DrPrachee Makashir |
Bharati Hospital and Research Centre |
Pune Satara Road Pune MAHARASHTRA |
9011073840
drprachee@gmail.com |
DrAshwini Joshi |
Ganesh Kala Krida COVID Centre |
Near Nehru Stadium Swargate,Pune-411042 Pune MAHARASHTRA |
9422004212
drjoshiashwini77@gmail.com |
Dr Gajanan Kurundkar |
Smt. Kashibai Navale General Hospital |
Department of General Medicine, S.No. 49/1, Narhe,
Off Mumbai - Pune Bypass, Pune- 411041
Pune MAHARASHTRA |
9921244263
gbkurundkar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 3 |
Name of Committee |
Approval Status |
Ethics Committee,Jehangir Clinical Development Centre.Pvt.Ltd. |
Approved |
Institutional Ethics Committee Bharati Hospital Deemed University |
Approved |
Institutional Ethics Committee, Smt. Kashibai Navale Medical College and General Hospital |
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 |
Comparator Agent |
Identical Plaebo |
Sucrose globules premedicated with liquid potency will be administered per orally. A single dose will consist of two globules of size 40. The dosage will be six times a day at an interval of 3 hours between two successive doses
In case patents are intubated, they will receive reconstituted dilution PO
Dosing frequency will be02 drops two hourly eight times a day.
Upon discharge, the dosage will be three times a day at an interval of 6 hours between two successive doses
|
Intervention |
Zincum muriaticum 200C |
Sucrose globules premedicated with liquid potency will be administered per orally. A single dose will consist of two globules of size 40. The dosage will be six times a day at an interval of 3 hours between two successive doses
In case patents are intubated, they will receive reconstituted dilution PO
Dosing frequency will be02 drops two hourly eight times a day.
Upon discharge, the dosage will be three times a day at an interval of 6 hours between two successive doses
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
A subject will be considered eligible for inclusion in this study only if ALL of the following criteria apply:
1. Hospitalized patient with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) (or any other confirmatory test to diagnose SARS-CoV-2 infection if there is such change in guidelines issued time to time by the Government of India, Task Force for COVID or any other concerned authority/body assigned for this purpose) as documented by either of the following:
PCR positive in sample collected < 72 hours prior to randomization; OR
PCR positive in sample collected ≥ 72 hours prior to randomization with documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.)
2. Subject (or legally acceptable representative) understands and agrees to comply with planned study procedures and provides informed consent prior to initiation of study procedures.
3. Male or non-pregnant female adult ≥18 years of age at time of enrolment.
4. Illness with ≤12 days duration, and at least one of the following:
Radiographic infiltrates by imaging captured during the period between date of admission to date of enrolment that is chest x-ray, CT scan, lung ultrasound.
Presence of clinical features of dyspnea and or hypoxia, fever cough including Respiratory rate > 24 breaths/min OR SpO2 < or equal to 94 on room air
Requiring supplemental oxygen
Requiring HFNO/NIV
5. Women of childbearing potential must agree either to abstinence or to use at least one primary form of contraception not including hormonal contraception from the time of screening till end of the study.
6. Subject (or legally acceptable representative) agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 till end of this study.
7. Subject (or legally acceptable representative) is willing to be a study participant and to accept randomization to any assigned treatment arm.
|
|
ExclusionCriteria |
Details |
1. Physician makes a decision that trial involvement is not in patient’s best interest, or there is any condition that does not allow the protocol to be followed safely.
2. There is anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
3. Patient already in another clinical trial of an experimental treatment for COVID-19
4. Patient has a PaO2/FiO2 ratio < 200 or is requiring IMV/ECMO at baseline. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
TTR (Time to Recovery) |
Censored at Day 28
TTR is defined as the time (in days) from randomization of study treatment (active or placebo) until Day of recovery. Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the eight category ordinal scale |
|
Secondary Outcome
|
Outcome |
TimePoints |
Change from baseline in Alanine Transaminase (ALT) |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Change from baseline in Aspartate Transaminase (AST) |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Change from baseline in Total Bilirubin |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Change from baseline in Prothrombin Time (PT) |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Change from baseline in Creatinine |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Change from baseline in Haemoglobin |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Change from baseline in Total WBC count |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Change from baseline in Differential WBC count |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Change from baseline in Platelet count |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Change from baseline in Serum Ferritin levels |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Change from baseline in D-dimer levels |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Change from baseline in ESR |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Change in National Early Warning Score (NEWS) |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Clinical status using Ordinal scale |
Time Frame: Day 3 through Day 28 or discharge whichever is earlier |
Duration of hospitalization: Measured in days |
Time Frame: Day 0 through Day 28 |
Duration of NIV or HFNO use: Measured in days |
Time Frame: Day 0 through Day 28 |
Incidence of new NIV or HFNO use |
Time Frame: Day 0 through Day 28 |
Incidence of IMV or ECMO use |
Time Frame: Day 0 through Day 28 |
Mean change in the Ordinal scale |
Time Frame: Day 3 through Day 28 |
Percentage of subjects reporting each severity rating on an 8-point Ordinal scale |
Time Frame: Day 12 |
Subject 12-day mortality: Date and cause of death (if applicable) |
Time Frame: Day 0 through Day 12 |
Subject 28-day mortality: Date and cause of death (if applicable) |
Time Frame: Day 0 through Day 28 |
Time to an improvement of one category using an Ordinal scale |
Time Frame: Day 0 through Day 28 |
Time to an improvement of two categories using an Ordinal scale |
Time Frame: Day 0 through Day 28 |
Time to discharge or to a National Early Warning Score (NEWS) of or equal to 2, whichever occurs first |
Time Frame: Day 0 through Day 28 |
|
Target Sample Size
|
Total Sample Size="96" Sample Size from India="96"
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)
|
12/08/2020 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
None |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is being conducted to evaluate the efficacy of homoeopathy as an adjuvant therapy to standard of care in adult patients with moderate to severe COVID-19. This is a 12-month prospective, randomized, parallel group, double blind, placebo-controlled trial on homoeopathy medicine Zincum muriaticum 200C to assess the effect ( efficacy) of homoeopathy as an adjuvant therapy to standard of care in adult patients with moderate to severe COVID-19 virus infection versus the patients receiving identical placebo in addition to standard of care. The study will be conducted in 96 subjects (male and female), aged more than 18 years. |