| CTRI Number |
CTRI/2024/01/061531 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to determine the efficacy and safety of 101-PGC-005 drug for moderate Corona Virus Disease(Covid-19). |
|
Scientific Title of Study
|
A prospective, randomized, comparative, multi-centric, adaptive design clinical study to evaluate efficacy, safety and tolerability of 101-PGC-005 (‘005) for the treatment of moderate COrona VIrus Disease (Covid-19) disease patients. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICS/LAX/2022-005, version 2.0 date 02 Aug 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kartik Sahni |
| Designation |
Director |
| Affiliation |
Insignia Clinical Services Pvt. Ltd. |
| Address |
Insignia Clinical Services Pvt. Ltd. Room # 512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North West Delhi, India
North West
DELHI
110034
India |
| Phone |
9868679414 |
| Fax |
|
| Email |
kartik.sahni@insigniacs.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kartik Sahni |
| Designation |
Director |
| Affiliation |
Insignia Clinical Services Pvt. Ltd. |
| Address |
Insignia Clinical Services Pvt. Ltd. Room # 512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North West Delhi, India
North West
DELHI
110034
India |
| Phone |
9868679414 |
| Fax |
|
| Email |
kartik.sahni@insigniacs.com |
|
Details of Contact Person
Public Query
|
| Name |
Kartik Sahni |
| Designation |
Director |
| Affiliation |
Insignia Clinical Services Pvt. Ltd. |
| Address |
Insignia Clinical Services Pvt. Ltd. Room # 512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North West Delhi, India
North West
DELHI
110034
India |
| Phone |
9868679414 |
| Fax |
|
| Email |
kartik.sahni@insigniacs.com |
|
|
Source of Monetary or Material Support
|
| Laxai Life Sciences Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Laxai Life Sciences Pvt Ltd |
| Address |
3rd Floor, Ventureast Plaza, Plot #40 & 41, Road No.2, Financial District, Nanakramguda, Ranga Reddy District, Telangana-500032 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| One O One Therapeutics |
Menachem Begin Rd. 121, Floor 57, Tel Aviv-Yafo, Israel |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jitendrakumar Someshwar Anand |
Anand Multispeciality Hospital |
Consulting Room No 02, Department of Medicine 4th Floor
Sarthak Mall Mahatma Mandir Road, Saragasan Cross Road, Gandhinagar, 382421
Gandhinagar
GUJARAT |
9824517101
jkanand@gmail.com |
| Dr P Sridhar Reddy |
Banu Hospital Unit of PCRI |
Department of Clinical Research 302, 3rd floor
1-53, 1st line Srinagar, Chinnapadugupadu, Kovur, Nellore, India-524137
Nellore
ANDHRA PRADESH |
9440786412
sridhar@pcripl.com |
| Dr Govardhan Rao MV |
Excel Hospital |
56 by 29 Old Alwal Road Beside Bharat Petroleum Near IG Statue Banda Basti Secunderabad
Medchal
TELANGANA |
9440664042
drgovardhanmd1278@gmail.com |
| DrRahul Vasantrao Sonawane |
Saikrupa Hospital |
Saikrupa Research Department 3rd floor Renuka Corner Tapkir Chowk Thergaon 411033
Pune
MAHARASHTRA |
9420705185
dr.rahulsonawane7@gmail.com |
| Dr Ketan Ravindra Kshirsagar |
Sangvi Multispeciality Hospital Pvt.Ltd |
Clinical Research Department Room No 404, 4th floor, Krushna Chowk, Krushna Nagar, New Sangvi, 411027
Pune
MAHARASHTRA |
9049002749
kshirsagardrketan@gmail.com |
| Dr Rajas Walinjkar |
SevenHills Hospital |
Department of Medicine, Level 02, block 10, room no 3096, Marol Maroshi Road Andheri (East), Mumbai-400059
Mumbai
MAHARASHTRA |
7021825018
drrajaswalinjkar@gmail.com |
| Dr Poorna Prasad |
Shettys Hospital |
Department of Medicine
Plot No 11 and 12 12th F Main Kaverinagar
Bommanahali
Bangalore
KARNATAKA |
9741941064
spoornaprasad123@gmail.com |
| Dr Vishal Gupta |
SMS Medical College and Attached Hospital |
Department of Medicine, 4th Floor, RUHS Hospital of medical Sciences
J.L.N Road 303004
Jaipur
RAJASTHAN |
8107769802
drvishalgupta@gmail.com |
| Dr Mantri Sumant Narayan |
Sri Venkateshwara Hospital |
Sky Heights Site No 1 by 2. Sarjapura Attibele Main Road Indelebele Village 562107
Bangalore
KARNATAKA |
9900236821
mantrisumanthnarayan@gmail.com |
| Dr Abhishek Madhav Karmalkar |
Vedant Multispecialty Hospital |
Clinical Research Department Ground Floor GP 83 Opp to Rotary Club Sambhaji Nagar MIDC Chinchwad
Pune
MAHARASHTRA |
9970004295
drkarmalkar.vedant@gmail.com |
| Dr Premdeep Changalva |
Vijaya Super Speciality Hospital |
Department of Medicine, 4th Floor room no 401
16-II 41 A Raghav Cine Complex Road Pogatotha- 524001
Nellore
ANDHRA PRADESH |
8096368108
drpremdeepchangalva@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Anand Ethics Committee |
Approved |
| Ethics Committee S.M.S. Medical College and Attached Hospitals |
Approved |
| Excel Hospital Ethics Committee (A Unit of Bhargava Sai Healthcare) |
Approved |
| Institutional ethics Committee Sangvi Multispeciality Hospital |
Approved |
| Institutional Ethics Committee Vedant Multispeciality Hospital |
Approved |
| Medical Ethics Committee Seven Hills |
Approved |
| PCRI Ethics Committee |
Approved |
| Saikrupa Hospital Institutional Ethics Committee |
Approved |
| Shettys Hospital Ethics Committee |
Approved |
| Sri Venketeshwara Hospital Ethics Committee |
Approved |
| VIJAYA ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U071||COVID 19 virus identified, (2) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
01-PGC-005 |
101-PGC-005 20 mg inj. once daily for 3 days + SOC |
| Comparator Agent |
Dexamethasone |
Dexamethasone 6mg inj once daily for min 5 days and max. 10 days + SOC |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients of age 18 to 65 years (both inclusive) who have been hospitalized for treatment of moderate COVID-19 disease.
2. Patients with moderate COVID-19 disease severity, as defined by Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI, AND having any of the following symptoms and signs prior to randomization
a. Fever, cough, with or without sore throat, throat irritation, body ache, headache, malaise, weakness, diarrhoea or gastrointestinal upset, with or without anorexia, nausea, vomiting, with or without loss of smell and or taste, shortness of breath, breathlessness and difficulty in breathing
b. Respiratory rate of 24 to 30 breaths per min,
c. SpO2 90 – 93 percent on room air
3. Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (first RT-PCR positive sample collected within 7 days prior to randomization)
4. Elevated CRP, ESR or Ferritin levels
5. In case of female patients of child-bearing potential, a negative urine pregnancy test prior to beginning the therapy.
6. Willing to sign voluntary informed consent for participation in the study and willing to adhere to all protocol procedures. In case the subject is unable to provide informed consent than the same should be obtained from legally acceptable representative (LAR).
|
|
| ExclusionCriteria |
| Details |
1. Patients with mild or severe COVID-19 disease severity, as defined by latest Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI at the time of randomization. This includes any one or more of the following
a. Peripheral Blood oxygen saturation 94 percent or 90 percent
b. Respiratory Rate or less than 24 or more than 30 breaths per minute
2. First positive RT-PCR more than 7 days prior to treatment administration
3. Patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, cardiovascular or other systemic disease and or laboratory abnormality, which, in the opinion of the investigator, prevent the patient from participating in the study
4. Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR less than 30ml per min).
5. Renal dysfunction [Serum Creatinine more than 2.5 times of ULN or calculated creatinine clearance less than 30ml per min], Liver Dysfunction [Total Bilirubin more than 3 times ULN & AST, ALT more than 5 times ULN].
6. Chronic systemic glucocorticoid treatment or any immunosuppressive treatment
7. History of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
8. Pregnant and Lactating patients.
9. Patients who require IL-6 inhibitors for management of inflammation at the time of study entry.
10. Subject has a psychiatric disease that is not well controlled where controlled is defined as stable on a regimen for more than one year.
11. Hospital discharge is anticipated in less than 24 hours or anticipated transfer to another hospital which is not a study site within 72 hours.
12. Patients that are currently or have participated in such studies participating in other clinical studies with investigational drug, biological agent or device within 1 month or within 5 half-lives (of the drug or biologic) prior to randomization (whichever is longer).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical improvement or shift in WHO 11-point ordinal scale rating |
Baseline through Day 10, Day 14 and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in COVID-19 Symptoms such as Fever, Heart Rate and Oxygen Saturation (SpO2 |
Baseline through Day 10, Day 14 and Day 28 |
| Improvement biochemical inflammatory markers such as CRP, Neutrophil Lymphocyte ratio, D-Dimer, Serum Ferritin, IL-6, TNF alpha |
Baseline, End of Treatment, Day 5 or Discharge, Day 10, 14 and 28 |
| Requirement of auxiliary oxygen therapy |
28 Days |
| Discharge Rate from hospital |
28 Days |
| Rate of ICU Admission , Mechanical Ventilation |
28 Days |
| Time to respiratory viral clearance |
Day 3, 7, 10 and 14 |
| Improvement in lung injury on Chest HRCT |
Baseline, 28 Days |
| All-cause mortality |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="268"
Sample Size from India="268"
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 3 |
|
Date of First Enrollment (India)
|
21/01/2024 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Coronavirus disease 2019 (COVID-19) is defined as illness caused by a novel coronavirus now called Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2; formerly called 2019-nCoV), which was first identified amid an outbreak of respiratory illness cases in Wuhan City, Hubei Province, China. It was initially reported to the WHO on December 31, 2019. On January 30, 2020, the WHO declared the COVID-19 outbreak a global health emergency. COVID-19 disease does not have any approved treatment. However, an array of drugs approved for other indications, as well as multiple investigational agents, are being studied for the treatment of COVID-19 in several hundred clinical trials around the globe. The recent RECOVERY Trial demonstrated the success of dexamethasone in treating late stage COVID-19 patients. However, use of Dexamethasone increased mortality in early stage of the disease and due to limitations of use of free dexamethasone because of the dose and duration that is insufficient to properly treat COVID-19 patients. As majority of the cells have glucocorticoid receptors to which the dexamethasone binds, highly toxic dose would be needed to effectively treat . COVID-19 disease which would result in increase in mortality and this dose may modulate T cells and other immune cells, resulting in decreased natural immunity. 101- PGC-005 (‘005), which is a prodrug of dexamethasone will address the many safety issues limiting this most powerful anti-inflammatory agent. This is a prospective, randomized, comparative, multi-centric, adaptive design clinical study to evaluate efficacy, safety and tolerability of 101-PGC-005 (‘005) when used alongside Standard of Care (SOC) for the treatment of hospitalized patients with coronavirus disease (COVID-19). |