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CTRI Number  CTRI/2020/05/025483 [Registered on: 30/05/2020] Trial Registered Prospectively
Last Modified On: 11/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of Clevira in COVID19 patients 
Scientific Title of Study   A Randomized, Multicentric, Open label, Parallel group Clinical study to Evaluate the EFFICACY and SAFETY of CLEVIRA in mild to moderate COVID19 POSITIVE Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramesh Kannan 
Designation  Assistant Professor 
Affiliation  Madras Medical College 
Address  Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu
Consultant, Room no:10, Medicine OPD, PM Medical Centre & Ki3(SMO), Tamil Nadu.
Chennai
TAMIL NADU
600003
India 
Phone  9677786447  
Fax    
Email  srkguruvarshan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesh Kannan 
Designation  Assistant Professor 
Affiliation  Madras Medical College 
Address  Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu
Consultant, Room no:10, Medicine OPD, PM Medical Centre & Ki3(SMO), Tamil Nadu.

TAMIL NADU
600003
India 
Phone  9677786447  
Fax    
Email  srkguruvarshan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramesh Kannan 
Designation  Assistant Professor 
Affiliation  Madras Medical College 
Address  Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu
Consultant, Room no:10, Medicine OPD, PM Medical Centre & Ki3(SMO), Tamil Nadu.

TAMIL NADU
600003
India 
Phone  9677786447  
Fax    
Email  srkguruvarshan@gmail.com  
 
Source of Monetary or Material Support  
Apex Laboratories Private limited, SIDCO , Guindy, Chennai 
 
Primary Sponsor  
Name  Apex Laboratories Pvt Ltd  
Address  SIDCO Complex, Guindy, Chennai  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Narayana Babu  Government Medical College  COVID19 Isolation wards , Department of General Medicine, No. 169, Wallajah Road, Omandurar Govt. Estate, Triplicane, Chennai, Tamil Nadu 600002
Chennai
TAMIL NADU 		 9677786447

gmcomandurar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government medical College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
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  CLEVIRA tablet twice daily for 14 days  Composition of one CLEVIRA tablet includes extracts namely: Erandakarkati (Carica papaya)-Lf. – 100mg, Mahanimba (Melia azedarach)-Lf. – 100mg, Kalmegh (Andrographis paniculata)-Herb – 100mg, Usira (Vettiverazizanoides)-Rt.– 35mg, Patola (Tricosanthusdioica)-Wh.Pl.– 35mg, Musta (Cyperusrotundus)-Rz. – 35mg, Sunthi (Zingiber officinale)- Rz. – 35mg, Maricha (Piper nigrum)-Fr. – 35mg, Grismachatraka (Mollugocerviana)-Wh.Pl.– 35mg, Guduchi (Tinosporacordifolia)-St. – 10mg. Given twice daily for 14 days 
Comparator Agent  Standard treatment group   Treatment given as per WHO/ICMR guidelines 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Willing and able to provide written informed consent prior to performing study procedures.
2. Males and females between the age of 18-50 years.
3. Mild to moderate COVID-19 associated disease as defined by the WHO.
4. Hospitalized patient.
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR.
6.Illness of any duration and febrile/afebrile. Febrile-defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal documented within 48 hours of consent.
 
 
ExclusionCriteria 
Details  1. Participation in any other clinical trial of an experimental treatment for COVID-19
2.Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study medication initiation
3.Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
4.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
5.Pregnant women or women who are breastfeeding
6.Immunocompromised patients taking medication upon screening
7.Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a.Time taken for clinical recovery, which is defined as;
1. Normalization of pyrexia and body pain
2. Respiratory rate less than 24/minute
3.Spo2 rate greater than 94%
4. Relief from cough and maintenance of above for more than 72 hours.
b.Proportion of patients with swabs negative for COVID19 in RT PCR at day 5, 10 and 15
c.Reduction of Viral Load.
 		 At day 5, day 10 and day 15 
 
Secondary Outcome  
Outcome  TimePoints 
a.Clinical status of subject (on a 6 point ordinal scale).
1. Discharged having reached clinical recovery criteria
2. Hospital admission, but not requiring supplemental oxygen
3. Hospital admission, requiring supplemental oxygen
4. Hospitalized, on non-invasive ventilation or high flow oxygen devices
5. Hospitalized, on invasive mechanical ventilation or ECMO;
6. Death.

b.All cause of death/mortality
c.Duration of hospitalization
d.Adverse events if any  		 At day 5, day 10 and day 15 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   02/06/2020 
Date of Study Completion (India) 30/06/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Under publication process 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A total of 100 patients confirmed with COVID19 infection(mil to moderate cases) by RT-PCR will be included in the study. The selection of the patients will be based on initial screening and study criteria. Participants will be randomized into 2 groups with 50 patients in each group.

  • Group 1(Control arm) – Patients diagnosed as  SARS-CoV-2 infection will receive standard of care treatment(as per hospital regulation) as per the WHO/ICMR guidelines.All key co-interventions will be documented.
  • Group 2(Treatment arm)-  Patients diagnosed as  SARS-CoV-2 infection will receive  standard of care treatment(as per hospital regulation) as per the WHO/ICMR guidelines. In addition tablet CLEVIRA will be given twice daily for 14 days.
  • The mentioned Primary & secondary outcomes will be assessed.
 
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