| CTRI Number |
CTRI/2020/08/026957 [Registered on: 02/08/2020] Trial Registered Prospectively |
| Last Modified On: |
06/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial to evaluate the effect of a combination of treatment of Reginmune capsule and Immunofree tablets in the treatment of mild to moderate COVID-19 patients |
|
Scientific Title of Study
|
An open label, multicenter, randomized, controlled, clinical study to evaluate the efficacy and safety of a combination of treatment of Reginmune capsule and Immunofree tablets compared with standard treatment protocol in the treatment of mild to moderate COVID-19 patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MGCTS/20/105 VERSION: 01 DATED 08 JUN 2020 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijaykumar Kamat |
| Designation |
Medical Director |
| Affiliation |
Corival Lifesciences Pvt Ltd |
| Address |
G24,Grd Flr,Laxmi Wollen Mills Comp, Shakti Mill Lane
Dr Emoses Road Mahalaxmi
Mumbai
MAHARASHTRA
400011
India |
| Phone |
9886692767 |
| Fax |
|
| Email |
drvijaykamat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit Munshi |
| Designation |
Clinical Research Consultant |
| Affiliation |
Mittal Global Clinical Trial Services |
| Address |
Clinical QA and Scientific Writing,
121-B, Mansarovar Industrial Estate Extn
Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9822371703 |
| Fax |
|
| Email |
drabhijit@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Director Clinical Research |
| Affiliation |
Mittal Global Clinical Trial Services |
| Address |
Clinical Operations Division,
121-B, Mansarovar Industrial Estate Extn
Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
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Source of Monetary or Material Support
|
| Biogetica, G- Laxmi Wollen Mills Comp, Shakti Mill Lane, Dr Emoses Road Mahalaxmi Mumbai |
| Corival Lifesciences Private Limited, G24,Grd Flr,Laxmi Wollen Mills Comp, Shakti Mill Lane, Dr Emoses Road Mahalaxmi Mumbai |
|
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Primary Sponsor
|
| Name |
Corival Lifesciences Private Limited |
| Address |
G24, Grd Flr, Laxmi Wollen Mills Comp,
Shakti Mill Lane
Dr Emoses Road Mahalaxmi Mumbai Mumbai City Mh 400011 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhirkumar bhatnagar |
Abhinav multispeciality hospital |
Cardiology Dept, Abhinav Multispeciality Hospital, kamal chowk,Nagpur
Nagpur
MAHARASHTRA |
9545069465
drabhijitmunshi@gmail.com |
| Dr A Gopal Rao |
Govt Medical College and Govt General Hospital ( Old RIMSGGH) |
Department of General Medicine, Hudco Colony, Balaga, Srikakulam, Andhra Pradesh 532001
Srikakulam
ANDHRA PRADESH |
9440122790
drgopalraoa@gmail.com |
| Dr Vidyadhar G Vaidya |
Lokmanya Hospital |
Second floor, Infectious disease division, 314/B Telco Road, Chinchwad, Pune 33 Pune
Pune
MAHARASHTRA |
9822057766
vgvaidya001@gmail.com |
| Dr Nandkishor Umale |
Parul Institute of Ayurveda and Research Parul University |
COVID Ward, Parul Sevashrama Hospital Parul University Limda Vadodara Gujarat
Vadodara
GUJARAT |
8379815979
nandkishor.umale260079@paruluniversity.ac.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Parul Institute of Ayurved |
Approved |
| Institutional ethics committee Lokmanya Medical Research Center |
Approved |
| Institutional Ethics Committee, Govt Medical College and Govt General Hospital |
Approved |
| Jasleen Hospital Ethics Committee Nagpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Immunofree 500 mg tablets
2. Reginmune 750 mg capsule |
2 tablets Immunofree 500 mg tablets thrice a day for 10 days and 1 capsule Reginmune 750 mg twice a day for 10 days |
| Comparator Agent |
As per hospital protocol for Covid-19 |
As per standard National Clinical Management Protocol for COVID-19 by Government of India, Ministry of Health and Family Welfare, Directorate General of Health Services, (EMR Division), Version 3, 13.06.20 |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Gender: Either male or non-pregnant, non-lactating female aged > 18-70 < years (both inclusive).
2. Patients with RT-PCR confirmed diagnosis of COVID-19
3. Patients with mild to moderate COVID-19 infection having either one of the following criteria:PaO2/FiO2:200-300 OR Respiratory rate ≥ 24/min and SaO2/SpO2 > 90% on room air
4. Subjects willing to give written informed consent
5. Subjects able to take the drug orally and comply with the study protocol
6. Women of child bearing potential must have a negative urine pregnancy test prior to study entry |
|
| ExclusionCriteria |
| Details |
1. Patients with persistent vomiting
2. Critically ill patients
3.P/F ratio less than 200 (moderate-severe ARDS)
4.Shock (Requiring Vasopressor to maintain a MAP more than 65 mm of hg or MAP below 65)
5.Patients with known active hepatitis, tuberculosis and definite bacterial or fungal infections
6.Patients with altered mental state
7.Patients with multiple organ failure requiring ICU monitoring and treatment
8.Patients with respiratory failure and requiring mechanical ventilation
9.Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia etc.) that, in the opinion of investigator precludes the subject’s participation in the study or interferes with the interpretation of the study results.
10.Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.
11.Patients who have received specific antiviral drugs ritonavir/lopinavir, or chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week before admission
12.Patient who have participated in another investigational study within 3 months prior to enrollment in this study
13.Investigators, study personnel, sponsor’s representatives and their first-degree relatives.
14.Pregnant subjects
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Time (Days) to clinical improvement from study enrollment |
Day 0, Day 5 and Day 10 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Responders as assessed by the global assessment of symptoms |
Day 0 - Day 10 |
| Rate of patients showing improvement of 2 points in 7 category ordinal scale |
Day 0, Day 5±1 and Day of discharge i.e Day 10±1 |
| Clinical status as assessed by the 7-point ordinal scale |
Day 0, Day 5±1 and Day of discharge i.e Day 10±1 |
| Proportion of participants in each group with normalization of fever |
Day 0, Day 5±1 and Day of discharge i.e Day 10±1 |
| Proportion of participants in each group with oxygen saturation more than 94% on room air for more than 24h |
Day 0, Day 5±1 and Day of discharge i.e Day 10±1 |
| Time to first negative SARS-CoV-2 PCR in NP swab |
Day 0, Day 5±1 and Day of discharge i.e Day 10±1 |
| Duration of oxygen therapy |
Day of discharge |
| Proportion of participants in each group with need for mechanical ventilation |
Day of discharge |
| Duration of hospitalization |
Day of discharge |
| Value of coagulation indicators D-dimer (DD) |
Day 0, Day 5±1 and Day of discharge i.e Day 10±1 |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/08/2020 |
| Date of Study Completion (India) |
01/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Primary Study Objective: The objective of this study
is to evaluate the efficacy of a combination of the Herbal and Nutraceutical formulations Immunofree
tablets and Regimmune capsules on mild and moderate covid19 patients in
comparison with the standard treatment protocol in use in Hospitals.
Design: An open label, multicentre, randomized,
comparative, parallel group, controlled study
Setting: The study was done as per ICH GCP
guidelines at 4 sites with approval from respective Ethics committees.
Participants: 50 subjects (mean age 43.2 years)
received the test product (Immunofree tablets and Reginmune Capsule) and 50
subjects (mean age 41.76 years) received Standard of care treatment as control.
Intervention: 2 tablets thrice a day at an interval of 4-5 hours for 10 days
and 1 Reginmune capsule twice a day for 10 days
Primary Outcome Measure: The analysis was done on
efficacy pathological tests like RT-PCR, Procalcitonin, ESR, C-reactive
protein, eosinophil, Temperature, SpO2, Respiratory rate & D-dimer along
with the Clinical and Subject’s Global Assessment of Symptoms. The assessments
were done on day 0, day 5, and day 10.
Results: 88% of the subjects in Immunofree tablet +
Reginmune capsule group were shown to be virologically cured (RT/PCR negative)
day 5 and discharged from the hospitals at Day 5 when compared to 72% (RT/PCR
Negative) of the subjects in the standard of care group at Day 5. At Day 10 of
treatment all patients were virologically cured in Immunofree tablet +
Reginmune capsule when compared to 88% of the patients cured in the Standard of
Care. The global assessment shows quicker symptoms relief in the test group
than the control group. In most other pathological assessments, the individual
arm data for the two arms is significant, but their comparative data is
similar.
In conclusion, the time to 2-point clinical
improvement as per 7 point ordinal WHO scale was seen in favour in the
Immunofree tablet + Reginmune capsule group when compared to the standard of
care. The results were significant.
The Immunofree tablet + Reginmune capsule treatment
was very effective in virological results. Immunofree tablet + Reginmune
capsule treatment reduced Covid 19 symptoms when compared to the baseline.
It reduces Inflammatory marker CRP levels when
compared to the baseline and also when compared to the standard of care.
It increases the Immune parameters of Total
leukocyte counts, Platelets, Neutrophils and Lymphocytes when compared to
Standard of care.
It improves the Blood oxygen saturation levels.
It improved the chest findings in Chest X-Ray.
All the biochemical tests were normal at baseline
and post study.
There were no serious adverse events reported in the
study.
Overall Immunofree tablet + Reginmune capsule group
was effective in treating the Covid-19 patients than the standard of care. The
Immunofree tablet + Reginmune capsule group was tolerated very well in Covid-19
patients. The overall results in the Intervention are encouraging for Mild to
Moderate Covid19 cases.
|