| CTRI Number |
CTRI/2020/07/026789 [Registered on: 25/07/2020] Trial Registered Prospectively |
| Last Modified On: |
14/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to see effect of ArtemiC in patients with COVID-19 |
|
Scientific Title of Study
|
A Phase II, controlled clinical study designed to evaluate the effect of ArtemiC in patients diagnosed with COVID-19 |
| Trial Acronym |
ArtemiC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MGC-006 Version 03 dated 14 May 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Syed Umar Quadri |
| Designation |
Principal Investigator |
| Affiliation |
Mahatma Gandhi Missions Medical College & Hospital |
| Address |
Department of Clinical
Pharmacology &
Therapeutics,MGM
Medical College and
Hospital N-6 Cidco,
Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9923798702 |
| Fax |
|
| Email |
umarazmed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt.Ltd |
| Address |
Office No. 02, 03 & 04, 2nd Floor Highland Corporate Center,
Kapurbawdi Junction,
Thane
MAHARASHTRA
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt.Ltd |
| Address |
Office No. 02, 03 & 04, 2nd Floor Highland Corporate Center,
Kapurbawdi Junction,
Thane
MAHARASHTRA
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
|
Source of Monetary or Material Support
|
| Biosphere Clinical Research Pvt.Ltd
Office No. 02, 03 & 04, 2nd Floor Highland Corporate Center,
Kapurbawdi Junction,
Thane
MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
MGC Pharmaceuticals Ltd |
| Address |
1202 Hay Street, Perth WA 6005, Australia
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Oz Innovative Solutions Pty Ltd |
8 Hope Court, Mill Park. Victoria.
Australia |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSyed Umar Quadri |
Mahatma Gandhi Missions Medical College & Hospital |
Department of Clinical
Pharmacology &
Therapeutics,MGM
Medical College and
Hospital N-6 Cidco,
Aurangabad-431003
Aurangabad
MAHARASHTRA |
9923798702
umarazmed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Ethics Committee for Research on Human Subjects (MGM-ECRHS) |
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 |
ArtemiC medical spray |
ArtemiC is a Oromucosal medical spray combined of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (15 mg/ml) and vitamin C (60 mg/ml) in spray administration.
given as add-on therapy, 2 times a day, on Days 1 and 2.Each dose contains 1ml (10 puffs-pushes on the spray bottle) , total daily dose 2ml (20 puffs- pushes on the spray bottle).The total treatment is 40 puffs for 2 days. |
| Comparator Agent |
Placebo |
Placebo is a Oromucosal medical spray will be given as add-on therapy, 2 times a day, on Days 1 and 2.
Each dose contains 1ml (10 puffs-pushes on the spray bottle) , total daily dose 2ml (20 puffs- pushes on the spray bottle).The total treatment is 40 puffs for 2 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Confirmed SARS-CoV-2 infection.
2. Hospitalized patient with COVID-19 of moderate stable or worsening severity not requiring ICU admission, and on the other hand not experiencing clinical improvement under ongoing standard care.
3. Age: 18 years old and above.
4. Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
5. Ability to receive treatment by spray into the oral cavity |
|
| ExclusionCriteria |
| Details |
1. Tube feeding or parenteral nutrition.
2. Oxygen requirements beyond use of nozzles or simple mask as per score 4
3. Respiratory decompensation requiring mechanical ventilation.
4. Uncontrolled diabetes type 2.
5. Autoimmune disease.
6. Pregnant or lactating women.
7. Need for admission to ICU in the course of the present hospitalization at any time prior to completion of the recruitment to the study.
8. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of ≤ 2 Maintained for 24 Hours in comparison to routine treatment
2.Percentage of participants with definite or probable drug related adverse events |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time until negative PCR
2. Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms
3.COVID-19 related survival
4.Incidence and duration of mechanical ventilation
5.Incidence of Intensive Care Init (ICU) stay
6.Duration of ICU stay
7.Duration of time on supplemental oxygen
8.Additional Data will be recorded to complete the Core Set of Outcomes |
15 Days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
31/07/2020 |
| 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="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)?
|
|
Brief Summary
|
This Study is A Phase II, controlled clinical study designed to evaluate the effect of ArtemiC in patients diagnosed with COVID-19.
The primary outcomes: Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of Percentage of participants with definite or probable drug related adverse events
The secondary outcomes: Time until negative PCR Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms COVID-19 related survival Incidence and duration of mechanical ventilation Incidence of Intensive Care Init (ICU) stay Duration of ICU stay Duration of time on supplemental oxygen Additional Data will be recorded to complete the Core Set of Outcomes |