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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  
Status 
Not Applicable 
 
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
 
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