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)
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2020/08/027284
- Lead Sponsor
- Dyuthi Biosciences Private Limited
- 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
Exploratory Objective:
Validate serology, inflammatory markers, cytokines and viral load translating into clinically relevant outcomes (reducing hospital stay or decreasing mortality)
**Background:**
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 44
- 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.
- 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.
- 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.
- Known asthma or COPD 4.
- Poorly controlled Diabetes 5.
- Lobar or segmental consolidation on chest imaging or on clinical signs.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Clinical recovery on a 7-point ordinal scale At the end of the study (Time of clinical recovery) 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 Measures
Name Time Method 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,)
Trial Locations
- Locations (1)
Bangalore Institute of Gastroenterology Super Speciality Hospitals
🇮🇳Bangalore, KARNATAKA, India
Bangalore Institute of Gastroenterology Super Speciality Hospitals🇮🇳Bangalore, KARNATAKA, IndiaDr Srinath DoddarangappaPrincipal investigator9986764886srinathdoddarangappa@gmail.com