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CTRI Number  CTRI/2020/09/028044 [Registered on: 24/09/2020] Trial Registered Prospectively
Last Modified On: 02/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Phase IV study to evaluate the safety and efficacy of Artemisinin- a herbal supplement on COVID-19 subjects 
Scientific Title of Study   A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ARTI/WBPL/P4/2020/01 Version 1.1 dated 25 Aug 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Antaryami Maharana 
Designation  Head-Medical Affairs 
Affiliation  Abiogenesis Clinpharm Private Limited  
Address  8-2-596A B1,first floor, Department of Medical Affairs , Doctus Towers Road No. 10, Banjara Hills

Hyderabad
TELANGANA
500034
India 
Phone  914038117077   
Fax    
Email  antaryami@abiogenesisclinpharm.com  
 
Details of Contact Person
Public Query  
Name  Mukesh Kumar 
Designation  Manager- Regulatory Department  
Affiliation  Windlas Biotech Private Limited 
Address  Department of Regulatory Affairs, Khasra no. 141 to 143 and 145,Mohabewala, Industrial Area

Dehradun
UTTARANCHAL
248110
India 
Phone  1356608000   
Fax    
Email  regaffairs@windlasbiotech.com  
 
Source of Monetary or Material Support  
Windlas Biotech Private Limited Khasra no. 141 to 143 &145,Mohabewala, Industrial Area, Dehradun, 248110 Uttarakhand India 
 
Primary Sponsor  
Name  Windlas Biotech Private Limited 
Address  Plant 2,Khasra no. 141 to 143 &145,Mohabewala, Industrial Area, Dehradun, 248110 Uttarakhand India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Sunil Naik  Government Medical College & Government General Hospital, Srikakulam  Department of General Medicine, Room No 4, Ground Floor, OPD Block,Government Medical College & Government General Hospital, Srikakulam- 532001
Srikakulam
ANDHRA PRADESH 		 8942279033

rimsresearch@gmail.com 
Dr Vijay B Barge  Rajarshi Chhatrapati Shahu Maharaj Government Medical college and Chhatrapati Pramila Raje Hospital  Department of Medicine, CPR Hospital Campus, Dasara Chowk,Kolhapur- 431001
Kolhapur
MAHARASHTRA 		 9011066766

vijaybarge6766@gmail.com 
Dr Prashant V Rahate  Seven Star Hospital  Department of Surgery, O.P.D. No.: 1, Jagnade Square, KDK College Road,Nagpur-440009
Nagpur
MAHARASHTRA 		 09822464068

prashantrahate84@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee,Government Medical College and Government General Hospital, Srikakulam  Approved 
Institutional Ethics Committee,Rahate Surgical Hospital, Nagpur  Approved 
Institutional Ethics Committee,RCSMGMC and CPR Hospital , Kolhapur   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  Artemisinin 500 mg capsule  The dose regimen will be in cycles. In a cycle a subject will receive Artemisinin 500 mg capsule once daily plus SOC on Day 1 to Day 5 followed by 5 days off (no dosing of Artemisinin) or SOC alone. A subject can have a total of consecutive 3 cycles maximum. Here SOC is Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division) 
Comparator Agent  SOC  Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Male or female subjects of ≥18 to 60 years of age both inclusive
2.Subjects willing to give informed consent and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
3.Confirmed case of COVID-19 infection by RT-PCR and mild and moderate (without oxygen therapy or assisted ventilation) cases of COVID-19. Scores of 2-4 on the WHO Clinical Progression Scale
4.Time interval between symptoms onset and randomization of no more than 7 days
5.One or more of the following symptoms:
Fever
Cough
Sore throat
Headache
Nasal congestion
Malaise
Diarrhea
Loss of smell
Loss of taste
6.Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
 
 
ExclusionCriteria 
Details  1. Subjects with history of severe infections (pneumonia, septicemia, etc.), severe cardiac or pulmonary diseases, or received immunosuppressive therapy or other investigational drugs within the previous 30 days of screening
2. Known or suspected hypersensitivity to Artemisinin
3. Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study
4. Men who are unwilling to use contraception while receiving investigational product
5. Subjects with history of severe disease other than COVID-19 which is expected to prevent compliance with the present protocol
6. Subjects with history of severe renal and hepatic impairment. (creatine ≥2 mg/dl; liver enzymes and bilirubin 2.5 times ULN; alkaline phosphatase 1.5 times ULN)
7. Recent treatment with Artemisinin or Artemisinin based antimalarials in the past 7 days
8. Known history of failure to control systemic fungal, bacterial or viral infection
9. Patients with the history of following co-morbidities: diabetes, hypertension with or without cardiac symptoms, morbid obesity with diabetes and/or hypertension or any other metabolic syndrome
10. Subjects with known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection
11. Have a history of neurological or psychiatric disorders, including epilepsy or dementia
12. Subjects for whom ventilator support is required at screening
13. Patients not willing to stay in hospital for 5 days of isolation following diagnosis of Covid-19
14. Subjects not willing to give their informed consent to participate in the clinical trial
15. According to the investigator judgment there are concomitant diseases with a serious safety hazard or affect the subject
16. Using other experimental drugs or participating in other clinical trials in the prior one month 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Safety Assessments
- Adverse events (AEs) during the study
- Serious adverse events (SAEs) during the study 		 Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy
-Relief in the sign and symptoms of COVID-19 as per WHO Clinical Progression Scale.
-Relief in the sign and symptoms of COVID-19 per the Duration of Symptoms. 		 Day 28 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 4 
Date of First Enrollment (India)   30/09/2020 
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="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This will be an open label, prospective, multi-center, comparative, interventional study to evaluate safety and efficacy of Artemisinin 500 mg in subjects with mild to moderate COVID-19.

Initially subjects having mild to moderate COVID-19 will be screened as per predefined eligibility criteria for the study. Eligible 120 subjects will be enrolled to receive treatment with Artemisinin and SOC (Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division)) or SOC. Subjects will be randomized in 2:1 ratio. Group 1 will have 80 subjects and Group 2 will have 40 subjects.

 
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