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CTRI Number  CTRI/2020/08/027284 [Registered on: 20/08/2020] Trial Registered Prospectively
Last Modified On: 09/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   A study to evaluate the efficacy and safety of Aceinavir combined with supportive Standard of Care (SoC) in hospitalized patients with moderate coronavirus disease (COVID-19) 
Scientific Title of Study   A prospective, multicenter, randomized, open-label, parallel design study to evaluate efficacy and safety of Aceinavir combined with supportive Standard of Care (SoC) with moderate Coronavirus disease (COVID-19) in hospitalized patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
TG/PRO/CLI/035 Version 2.0 dated 14 Aug 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vishal Rao 
Designation  Overall Trial Coordinator 
Affiliation  HealthCare Global Enterprises Ltd. 
Address  HealthCare Global Enterprises Ltd. Department of Head Neck Surgical Oncology & Robotic Surgery 9/1, Kalinga Rao Rd, Sampangi Rama Nagar, Bengaluru, Karnataka 560002

Bangalore
KARNATAKA
560002
India 
Phone  9739774949  
Fax    
Email  drvishal.rao@hcgel.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sruthi Nambiar 
Designation  Medical Monitor 
Affiliation  TrialGuna 
Address  TrialGuna, Room No: 04, 467, 3rd Floor,1st Main, 4th Cross Rd, Royal County Layout, 2nd Block, 8th Phase, Bengaluru, Karnataka 560083

Bangalore
KARNATAKA
560083
India 
Phone  9663442072  
Fax    
Email  sruthi.nambiar@trialguna.com  
 
Details of Contact Person
Public Query  
Name  Dr Shashank Acharya 
Designation  Sponsor Representative 
Affiliation  Dyuthi Biosciences Pvt. Ltd 
Address  Dyuthi Biosciences Pvt. Ltd, Department of Research and Development, No 415/25/5,2nd Block, H.Nagar, Bangalore, Karnataka, India, 560085

Bangalore
KARNATAKA
560085
India 
Phone  9110430158  
Fax    
Email  dyuthibio@gmail.com  
 
Source of Monetary or Material Support  
Dyuthi Biosciences Private Limited No. 415/25/5, 2nd Block, Hanumantha nagar, Bangalore – 560085  
 
Primary Sponsor  
Name  Dyuthi Biosciences Private Limited 
Address  No. 415/25/5, 2nd Block, Hanumantha nagar, Bangalore – 560085 
Type of Sponsor  Other [Non-govt company] 
 
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 Srinath Doddarangappa  Bangalore Institute of Gastroenterology Super Speciality Hospitals  COVID Care unit, Room number 5, 100 Feet Road, No. 34, Ashoka Pillar Rd, 2nd Block, Jayanagar, Bengaluru, Karnataka 560011
Bangalore
KARNATAKA 		 9986764886

srinathdoddarangappa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HCG Central Ethics Committee  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  Aceinavir (1 gram uncoated tablet)  Arm A would enroll 22 moderately symptomatic COVID-19 subjects treated with Aceinavir (Investigational Product) and Standard of Care (SoC). Dose is 4 tablets thrice daily till end of clinical recovery or as per the discretion of clinical investigator  
Comparator Agent  Standard of Care (SoC)  Arm B would enroll 22 moderately symptomatic COVID-19 subjects treated with SoC. The Standard of Care(SoC) will be as per the local hospital protocol and as per recommendations / guidelines by the respective authorities (Ministry of Health and Family Welfare, CDC and USFDA) whichever fits best at the time of initiation of this study. This will also be followed by the best supportive care guidelines recommended by the authorities (Ministry of Health and Family Welfare, CDC and USFDA). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF)
1. Age 18-80 years (inclusive) at the time of signing ICF.
2. SARS-CoV-2 positive report – rtPCR or Rapid Antigen
3. Initial COVID-19 symptom onset within 4 days prior to Screening
4. For female subjects: evidence of post-menopause, or for pre-menopause subject’s negative pre-treatment serum or urine pregnancy test
5. Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment
6. SpO2 ≥ 93% on room air
7. Not participating in any other interventional drug clinical studies before completion of the present study.
 
 
ExclusionCriteria 
Details  Subjects meeting any of the following criteria must not be enrolled in the study:
1. Severe or critical COVID-19 illness: RR ≥26, HR ≥100, SpO2 <93% on room air or requires >2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥95%, systolic blood pressure < 110 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300
2. Inability to intake or tolerate oral medications.
3. Known asthma or COPD
4. Poorly controlled Diabetes
5. Lobar or segmental consolidation on chest imaging or on clinical signs.
6. Treatment with other drugs thought to possibly have activity against SARS-CoV-2
7. ALT or AST > 5 x upper limit of normal (ULN)
8. Female subject is pregnant or breastfeeding
9. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time to Clinical recovery on a 7-point ordinal scale
The scale is as follows: 0) No clinical or virological evidence of infection; 1) No limitation of activities 2) Limitation of activities 3) Hospitalized, no oxygen therapy 4) Oxygen by mask or nasal prongs 5)Non-invasive ventilation or high-flow oxygen 6) Intubation and mechanical ventilation 7) Ventilation + additional organ support – pressors, RRT, ECMO 8) Death
 		 At the end of the study (Time of clinical recovery) 
 
Secondary Outcome  
Outcome  TimePoints 
1) Proportions (Aceinavir vs. SOC) of subjects experiencing treatment-emergent adverse events
2) Percent of subjects with SARS-CoV-2 detectable in nasopharyngeal sample (Time Frame: Day 0 (if available) & Day 5,)
3) Quantitative SARS-CoV-2 virus in nasopharyngeal sample (Time Frame: Days 0 (if available), & Day-5)
4) Correlation of clinical status with serology and inflammatory markers
 		 1) Throughout the study
2) Day 0 (if available) and Day 5
3) Day 0 (if available) and Day 5
4) Serology on Day 6 and inflammatory markers on Day 0 and Day 6 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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   N/A 
Date of First Enrollment (India)   28/08/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Suspended 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Study Title: A prospective, multicenter, randomized, open-label, parallel design study to evaluate efficacy and safety of Aceinavir combined with supportive standard of care (SoC) with moderate Coronavirus disease (COVID-19) in hospitalized patients

Study Objectives:
Primary Objective: The primary objective of the study is to evaluate the clinical efficacy of Aceinavir on moderate COVID-19 illness in hospitalized patients

Secondary Objective:

1. Evaluate the safety and tolerability of Aceinavir on moderate COVID-19 illness relative to soc control arm
2. To compare duration required for change in disease status




Natural products have been – and continue to be – a rich source of drugs, they have provided the chemical template for most marketed drugs today. As novel drug development can take a lot of time, drug repurposing or repositioning approach can facilitate prompt clinical decisions and lower costs. In a repurposing approach, a combination of bioactive herbs was prepared that directly target viral structure, inhibit transmembrane protease serine 2 (TMPRSS2) activity, and inhibition of ACE2 receptor. Evaluation of these active phytochemicals was checked against SARS-CoV-2 using automated molecular docking tools. Its effectiveness was studied against Main Protease (Mpro), Spike (S) protein and RNA-dependent RNA polymerase (RdRp) as well as ACE2 receptor and serine protease 2 (TMPRSS2). Insilico drug-likeness was confirmed and pharmacokinetics of these phytochemicals was predicted.  Particle reduction technology was utilized in GMP adhered manufacturing process to improve solubility and enhance bioavailability. Swarna bhasma is incorporated in this polyherbal formulation as gold nanoparticles as it has significant applications in drug delivery and is capable of encapsulating active drugs and targeting.

Study Plan:

This is an exploratory study to evaluate the efficacy and safety of Aceinavir as an adjunct therapy for the treatment of moderately symptomatic COVID-19 subjects. A prospective, multicenter, randomized, parallel design study, open-label study. The study will randomize subjects between Arm A and Arm B.

44 subjects will be enrolled in this study after obtaining voluntary written consent for participation in the study from the subject or his/her legally acceptable representative (LAR). subject’s eligibility will be confirmed based on the inclusion and exclusion criteria.

Arm A would enroll 22 moderately symptomatic COVID-19 subjects treated with Aceinavir (Investigational Product) and SoC. Whereas,

Arm B would enroll 22 moderately symptomatic COVID-19 subjects treated with SoC.

The Standard of Care (SoC) will be as per the local hospital protocol and as per recommendations / guidelines by the respective authorities (Ministry of Health and Family Welfare, CDC and USFDA) whichever fits best at the time of initiation of this study. This will also be followed by the best supportive care guidelines recommended by the authorities (Ministry of Health and Family Welfare, CDC and USFDA).

 

Investigational Product - Aceinavir (1 gram uncoated tablet):

 

Dosage: 4gms i.e. 4 tablets- TDS – Four tablets three times daily

 

Dosage schedule can be modified under the discretion of the investigator based on the subject’s condition.

 

The scheduled visits are the following -

Screening visit / Visit 1: Day -2 to Day 0

Visit 2 - Day 1 to End of Treatment

Visit 3 – Day of Discharge (DOD)

Visit 4 (Telephonic follow Up): 7 days after end of treatment (+ 1 day)

The total duration of a subject’s participation will be approximately 24 days and the total duration of the study will be approximately 3 months.


 
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