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CTRI Number  CTRI/2021/02/031520 [Registered on: 24/02/2021] Trial Registered Prospectively
Last Modified On: 03/09/2021
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 the effect of ArtemiC in patients with COVID-19 
Scientific Title of Study   A Phase II, Open label controlled clinical study designed to evaluate the effect of ArtemiC in patients diagnosed with COVID-19. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MGC-007 Version 01 dated 27 January 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K Sunil Naik 
Designation  Principal Investigator 
Affiliation  Govt. Medical College & Govt. General Hospital (Old RIMSGGH), 
Address  Department of Medicine, Govt. Medical College & Govt. General Hospital (Old RIMSGGH), Srikakulam-532001, Andhra Pradesh, India.

Srikakulam
ANDHRA PRADESH
532001
India 
Phone  91-9440828299  
Fax  91-8942-279033  
Email  drsunilnaikggh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prabhakar Ranjekar 
Designation  Scientific Advisor 
Affiliation  Oz Innovative Solutions Pty Ltd 
Address  B11, Tarang, Gate 4 Abhimanashree Housing Society Pashan Road Pune

Pune
MAHARASHTRA
411008
India 
Phone  91-9823437353  
Fax    
Email  pranjekar@gmail.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, Second Floor, Highland Corporate Center, Kapurbawdi Junction, Thane West

Thane
MAHARASHTRA
400607
India 
Phone  02241006794   
Fax    
Email  drneeta@biospherecro.com  
 
Source of Monetary or Material Support  
Oz Innovative Solutions Pty Ltd,8 Hope Court, Mill Park. Victoria. Australia 
 
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 
Biosphere Clinical Research PvtLtd  Office No. 02, 03 & 04, 2nd Floor Highland Corporate Center, Kapurbawdi Junction, Thane MAHARASHTRA Thane MAHARASHTRA 400607 India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Sunil Naik  Govt. Medical College & Govt. General Hospital (Old RIMSGGH)  Department of Medicine, Govt. Medical College & Govt. General Hospital (Old RIMSGGH), Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH 		 91-9440828299
91-8942-279033
drsunilnaikggh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Govt. Medical College Govt.General Hospital Srikakulam  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. Ayurveda Condition: Janapadodhwamsa Vikara ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ArtemiC medical spray with standard of care treatment   ArtemiC is a medical nasal spray combined of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (15 mg/ml) and vitamin C (60 mg/ml) in spray administration. Patients will receive up to 12 mg Artemisinin, 40 mg Curcumin, 30 mg Frankincense and 120 mg vitamin C as a maximum dose per 24 hours, given as add-on therapy, 2 times a day, on Days 1 and 2.  
Comparator Agent  Standard of care treatment  Standard of care treatment as per the clinical management protocol for COVID-19 followed by the Hospital  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Confirmed SARS-CoV-2 infection.
2. Age: 18 years old and above.
3. Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
4. Ability to receive treatment by spray into the nasal cavity

Cohort 1:
1.10 Patients clinically assigned as moderate [Presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 < 92% range 90-92% on room air, Respiratory Rate more or equal to 24 per minute]
2.Patients with a score of 4 (oxygen by mask or nasal prongs) on the 8- point ordinal scale of clinical status used by WHO at baseline assessment

Cohort 2:
1.10 patients clinically assigned as severe (Clinical signs of Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 < 90% on room air) but not critically ill (acute respiratory distress syndrome [ARDS], multi organ failure or septic shock).

2.Patients with a score of 5 (Non-invasive ventilation or high flow oxygen) on the 8- point ordinal scale of clinical status used by WHO at baseline assessment.
 
 
ExclusionCriteria 
Details  1. Tube feeding or parenteral nutrition.
2. Critically ill patients, defined as those who are candidates for endotracheal intubation and invasive mechanical ventilation and those with ARDS, septic shock or multi-organ failure at baseline.
3. Uncontrolled diabetes type 2.
4. Autoimmune disease.
5. Pregnant or lactating women.
6. 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
Modification(s)  		 An Open list of random numbers 
Blinding/Masking
Modification(s)  		 Not Applicable 
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 Unit (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="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/02/2021 
Date of Study Completion (India) 03/06/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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)  
A Phase II, Open label controlled clinical study designed to evaluate the effect of ArtemiC in patients diagnosed with COVID-19. 
The primary outcomes of the study are

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 of the study are
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 Unit (ICU) stay
Duration of ICU stay
Duration of time on supplemental oxygen
Additional Data will be recorded to complete the Core Set of Outcomes
 
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