CTRI Number	CTRI/2023/04/051726 [Registered on: 18/04/2023] Trial Registered Prospectively
Last Modified On:	14/02/2024
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Drug
Study Design	Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study Modification(s)	A phase 1, single-center, study to evaluate the safety and tolerability of a new molecule in Oral Syrup and Oral Gummy (Chewable gel) for oral use in healthy and mild to moderate COVID-19 adult human subjects
Scientific Title of Study	A prospective, interventional, open-label, phase 1a/1b, single-center, clinical study to evaluate the safety and tolerability of NV-CoV-2 Oral Syrup and Oral Gummy (Chewable gel) for oral administration in healthy and mild to moderate COVID-19 adult human subjects.
Secondary IDs if Any Modification(s)	Secondary ID  Registry  KM-NVCoV2-001 Version 1.0 08 Aug 2022  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Nikalje Anand Marutirao  Address  Clinical Research Unit no. 602, 3rd Floor, Department of Clinical Pharmacology, Mahatma Gandhi Mission’s Medical College and Hospital, Aurangabad Aurangabad MAHARASHTRA 431003 India  Phone  9822496190   Fax     Email  anandnikalje@rediffmail.com
Details Contact Person Scientific Query	Name  Dr Suvarna T Chavan  Address  Karveer Meditech Pvt. Limited. Flat No. 55, Kailash Apartment, Phase-III, Near Kamgar Chowk, N-3, CIDCO, Aurangabad Aurangabad MAHARASHTRA 431003 India  Phone  9168523484   Fax     Email  suvarnarathod93@gmail.com
Details Contact Person Public Query Modification(s)	Name  Mr Pathan Azher Khan   Address  Pristyncr Solutions Pvt. Ltd. CTS No. 11632, Sharif Colony, Roshan Gate, Aurangabad, Maharashtra, India Aurangabad MAHARASHTRA 431001 India  Phone  9028912522   Fax     Email  pathanazherkhan@gmail.com
Source of Monetary or Material Support Modification(s)	Karveer Meditech Pvt Ltd Plot No 34, Vijay Nagar, Near Shahu Toll Naka, Karveer, Kolhapur, Maharashtra, India, 416000.
Primary Sponsor	Name  Karveer Meditech Pvt Ltd  Address  Plot No 34, Vijay Nagar, Near Shahu Toll Naka, Karveer, Kolhapur, Maharashtra, India, 416000  Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 2   Contact Person  Name of Site  Site Address  Phone/Fax/Email  DR Nikalje Anand Marutirao  Mahatma Gandhi Mission’s Medical College & Hospital, Aurangabad  Clinical Research Unit no. 602, 3rd Floor, Department of Clinical Pharmacology, MGM Medical College and Hospital, N-6 CIDCO, Aurangabad-431003, India Aurangabad   9822496190 anandnikalje@rediffmail.com  Dr Vijay Babu  SKS Hospital and Postgraduate Medical Institute, Salem  23, SKS Hospital Rd, Guptha Nagar, Alagapuram Periyaputhur, Salem, Tamil Nadu 636004 Salem   9944293939 drvijaymd@hotmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 2   Name of Committee  Approval Status  MGM Ethics Committee for Research on Human Subject  Approved  SKS Hospital Ethics Committee  Approved
Regulatory Clearance Status from DCGI Modification(s)	Status  Approved/Obtained
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Coronavirus as the cause of diseases classified elsewhere  Healthy Human Volunteers  Healthy
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Comparator Agent  Not Applicable  Not Applicable  Intervention  NV-CoV-2 Oral Gummy (Chewable gel)   Single dose(Phase 1a) once only in three cohorts of 500mg, 1000mg and 2000mg for oral administration via sub lingual route Multi-dose (phase1b) once every alternate day for five dosing days once in day in three cohorts of 500mg, 1000mg and 2000mg for oral administration via sub lingual route  Intervention  NV-CoV-2 Oral Syrup   Single dose (phase 1a) once only for oral administration in three cohorts of 10mg/kg; 20mg/kg and 40mg/kg. Multi dose (phase 1b) once every alternate day for five dosing days by oral administration in three cohorts of 10mg/kg; 20mg/kg and 40mg/kg.
Inclusion Criteria Modification(s)	Age From  18.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  Common for healthy subjects and COVID-19 patients: 1-Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study 2-Willing to be available for the entire study period and to comply with protocol requirements. 3-In the case of female subjects: a-Negative urine pregnancy test during screening and negative serum β-hCG test at check-in of each study period. b-Female subjects with childbearing potential or those within their first two years of onset of menopause must either abstain from sexual intercourse or use acceptable methods of birth control for at least 15 days before 1st dose till 15 days post-last-dose/ entire study period [Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed)]. c-They should not be in menstruation (bleeding per vaginum) on the day of the withdrawal of blood for the purpose of the study For healthy subjects 1-Normal, healthy, adult, human subject of 18 to 60 years (both inclusive) of age. 2-Body mass index in the range of 18 – 30 Kg/m2 (both inclusive). 3-Normal haemoglobin between 12.5 to 17.5 grams per deciliter (g/dL) for men and 11 to 16 g/dL for females or as per the discretion of PI/Physician. 4-Normal health status as determined by medical history and physical examination by the PI/Physician at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate and axillary temperature) measurements and physical examination at the time of screening as well as check-in during each study period. 5-With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis 6-With a normal or clinically non-significant 12-lead ECG. 7-With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies, Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV) antibodies, COVID-19 RT PCR. 8-Non-smokers and should not have been consuming any kind of tobacco products including chewing or inhaling tobacco in the form of jarda, pan, gutkha etc, Or, In the case of smokers, they should be willing to abstain from smoking or chewing any tobacco-containing product for at least 72.00 hours prior to check-in of the first period and throughout the duration of the study till safety samples are collected at the end of the study. For mild to moderate Covid-19 patients 1-Both male and female adult populations aged from 18 to 60 years will be included in the study. 2-Confirmed RT-PCR positive for SARS CoV-2 mild to moderate (as per WHO classification) or asymptomatic patients as determined by the principal investigator/ study physician. 3-Controlled Diabetes (Type 2 DM (Hb1Ac < 7) and Hypertension (Systolic BP<140 mm Hg or diastolic BP<90 mm Hg). 4-Patients having risk factors of hospitalization due to Covid-19. 5-Patients with BMI from ≥18 to ≤ 35 kg/m2.
ExclusionCriteria	Details  For healthy subjects: 1-Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood-forming organs. 2-History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 3-History of severe infection or major surgery in the past 6 months. 4-History of Minor surgery or fracture within the past 3 months. 5-Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological, or psychiatric diseases, or organ dysfunction. 6-Any major illness or hospitalization within 90 days prior to check-in of the first period. 7-Any other clinical condition like diarrhea or vomiting within three days prior to check-in of any period. 8-Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during four weeks before check-in of the first period and throughout the duration of the study until the post-study safety sample is collected. 9-Use of any depot injection or an implant of any drug within three months prior to check-in of the first period and throughout the duration of the study until the post-study safety sample is collected. 10-Use of any prescribed medication (including herbal medicines and vitamin supplements) within 30 days or within five half-lives of the drug, whichever is longer prior to check-in of the first period and throughout the duration of the study until the post-study safety sample is collected. 11-Use of any OTC products within 7 days or within five half-lives of the drug, whichever is longer prior to first check-in and throughout the duration of the study until the post-study safety sample is collected. 12-Use of any recreational drug or history of drug addiction. 13-Participated in any clinical investigation requiring repeated blood sampling, blood donation, or otherwise leading to blood loss of ≥300 mL in the past 90 days prior to first check-in. 14-Participated in any clinical study within the past 90 days prior to check-in. 15-Consumption of alcohol or alcoholic products within 24.00 hrs prior to check-in in each study period and throughout sampling time points. 16-Positive alcohol breath or urine screening for drug abuse tests during check-in in each study period. 17-Consumption of xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) within 48.00 hours prior to check-in in each study period and throughout sampling time points. 18-Consumption of grapefruit or its juice within 72.00 hours prior to check-in in each study period and throughout sampling time points. 19-Pregnant, lactating or nursing female subjects. 20-Female subjects using hormonal contraceptives (oral/implants). 21-History of allergy or hypersensitivity or intolerance to study drugs or its formulation excipients which, in the opinion of the PI/Physician, would compromise the safety of the subject or the study. 22-History of difficulty in the accessibility of veins in arms. 23-Evidence of an uncooperative attitude. For mild to moderate Covid-19 patients 1-If the physician as per their judgment considers the patient unsuitable for the study based on the history, nutritional status, physical appearance, or any other reason. 2-Likely need for hospital admission within 24 to 48 hrs of randomization as per the assessment of the physician. (SpO2- <94%) 3-Known hepatic & kidney disease. 4-Known patient of cardiovascular disease, including congenital and ischemic heart disease, congestive cardiac failure. 5-Uncontrolled Type 2 DM (Hb1Ac >7), Insulin-dependent DM & Uncontrolled HTN (systolic BP≥140 mm Hg or diastolic BP≥90 mm Hg. 6-Patients with BMI <18 and > 35 (Obese) Kg/m2 are not included in the study. 7-Hemoglobin < 8 g/dL. 8-Known patient of HIV or on any other anti-viral medication for a disease other than Covid-19 9-Pregnant, lactating women or nursing female subjects 10-Presence of debilitating diseases like Tuberculosis, Rheumatoid arthritis, Carcinoma, Known case of inflammatory autoimmune diseases of any kind, neurodemyelinating diseases like Multiple sclerosis, Transverse myelitis, Thyroid, adrenal, pituitary endocrine disorders, Renal failure, Inflammatory bowel disease. 11-Patients who had participated in another clinical trial within the previous 30 days. 12-Patients under immune suppressants and steroids (steroid for any other disease than Covid-19). 13-Signs and symptoms, haematological, imaging investigations showing signs of severe COVID will be excluded. 14-Any other medical conditions that are considered unsuitable for the study by the investigator. 15-The patient is not willing to give an informed consent form.
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	An Open list of random numbers
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  To evaluate the safety and tolerability with the initial administration of NV-CoV-2 in healthy human subjects. - To find the maximum tolerated dose for the support of phase-2 clinical trials.   Baseline and end of study
Secondary Outcome	Outcome  TimePoints  To evaluate the Pharmacokinetic (for healthy subjects only) and Pharmacodynamic nature (for Covid-19 patients only) of NV-CoV-2. - To obtain an early measurement of drug activity in mild/moderate COVID-19 patients.   Baseline and end of study
Target Sample Size	Total Sample Size="72" Sample Size from India="72"
Phase of Trial	Phase 1
Date of First Enrollment (India) Modification(s)	01/05/2023
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="1" Days="5"
Recruitment Status of Trial (Global)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details	Results shall be published in medical journals
Brief Summary	This is a phase 1 study to assess the safety and tolerability of a new molecule in healthy subjects. In Phase 1b patients with mild to moderate COVID19 shall be enrolled to assess any indication of efficacy.