A Phase II, Single blind, Randomized, Parallel group, Dose ranging, Single Dose Study of Dengue Monoclonal antibody (Dengue mAb) in
Adults with Dengue Fever
Secondary IDs if Any
Secondary ID
Registry
Dengue mAb-02 Version 2 dated 01 Oct 2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Atharva Multispecialty Hospital and Research Centre, Lucknow
Atharva Multispecialty Hospital and Research Centre, Lucknow, H-4/Comm-2, Construction Div-21, UP Avas Vikas Parishad, Sector-E, Lucknow-226003, Uttar Pradesh, India Lucknow
9554540710
vineetshukla38@gmail.com
Dr Sanjay Lalwani
Bharati Vidyapeeth Deemed to be University Medical college and Hospital Pune
Department of Pediatrics Bharati Vidyapeeth (Deemed to be University) Medical college & Hospital Pune - Satara Road, Katraj Dhankawadi, Pune - 41 1 043, Maharashtra, India. Pune
00912024364308
researchpedpune@gmail.com
Dr K Sunil Naik
Government Medical College
Government Medical College & Govt. General Hospital (Old RIMSGGH), Shantinagar Colony, Srikakulam - 532001 Srikakulam
9440828299
rimsrresearch@gmail.com
Dr Prachee Sathe
Grant Medical Foundation Ruby Hall Clinic
Department of Critical Care Medicine, Ruby Hall Clinic, Grant Medical Foundation, 40, Sassoon Road, Pune - 411001, Maharashtra, India. Pune
02066455100
prachee.sathe@gmail.com
Dr Sunil Kohli
Hamdard Institute of Medical Sciences and Research, New Delhi
Hamdard Institute of Medical Sciences & Research (HIMSR), And Associated Hakeem Abdul Hameed Centenary Hospital, Hamdard Nagar, New Delhi - 110062 New Delhi
01126059688
drskohli.himsr@gmail.com
Dr Kamal Ahmad
Indraprastha Apollo Hospitals, New Delhi
Department of Internal Medicine,
Indraprastha Apollo Hospitals,
Sarita Vihar, Delhi Mathura Road, New Delhi- India – 110076 New Delhi
01126925858
drkamalahmad@gmail.com
Dr Kiranjit Singh
Jehangir Clinical Development Centre.Pvt.Ltd. Pune
Department of Internal Medicine, Jehangir Clinical Development Centre. Pvt.Ltd. Jehangir Hospital Premises, 32 Sassoon Road, Pune-411001 Pune
02067268800
kiranjitsingh64@gmail.com
Dr Pradeep DCosta
KEM Hospital and Research Center, Pune
KEM Hospital and Research Center, 489, Sardar Mudaliar Road, Pune-411001, Maharashtra, India Pune
00919822632812
pradeepdcosta@yahoo.co.in
Dr Mandala Atchin Naidu
King George Hospital, Visakhapatnam
Department of General Medicine, Rajendra Prasad Ward
King George Hospital, Andhra Medical College,
Visakhapatnam-530002,
Andhra Pradesh,India. Visakhapatnam
00917993808034
drmatchinnaiduresearch@gmail.com
Dr Sandeep Kumar Gupta
M V Hospital and Research Centre, Lucknow
Medicine Department, Ground Floor, M V Hospital and Research Centre, 314/30, Mirza Mandi Chowk, Lucknow – 226003, Uttar Pradesh, India Lucknow
05222258215
sandeepkumar.gupta@rediffmail.com
Dr Rajesh Nair
Mar Augustine Golden Jubilee Hospital -MAGJ, Ernakulam
Department of General Medicine, Mar Augustine Golden Jubilee Hospital (MAGJ), Mookkannoor P. O Angamaly, Ernakulam – 683577, Kerala, India Ernakulam
04842616869
drnairrajesh@gmail.com
Dr Sushila Kataria
Medanta The Medicity, Gurgaon
Department of Internal Medicine, 6th Floor, Medanta The Medicity Sector 38, Gurgaon, Haryana- 122001, India. Gurgaon
01244141414
sushila.kataria@medanta.org
Dr Gaurish Gadbail
Nirmal Hospital Pvt Ltd, Surat
Clinical Research Department, Basement, Nirmal Hospital Pvt Ltd, Ring Road, Surat-395002, Gujarat, India. Surat
02612333999
dr.gaurishgadbail@gmail.com
Dr Aparna Kodre
Noble Hospital Pvt. Ltd., Pune
Noble Hospital Clinical Research Department (NHCRD),
Basement, Noble Annex, Noble Hospital Pvt. Ltd.
153 A, Magarpatta city, Road, Pune - 411013.
Maharashtra, India Pune
02066285000
draparnankodre@gmail.com
Dr Vijaykumar Barge
Rajarshee Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital Kolhapur
Department of clinical research.
St. Theresa’s Hospital, Sanathnagar,
Hyderabad – 500018, Telangana, India Hyderabad
09440978535
drcsanjaneyulu@gmail.com
Dr Renuka Munshi
Topiwala National Medical College and BYL Nair Charitable Hospital
Topiwala National Medical College & BYL Nair Hospital, 5th floor, Department of Clinical Pharmacology, TN Medical College & BYL Nair Hospital, Dr. AL Nair Road, Mumbai Central, Mumbai, Maharashtra 400008, India Mumbai
02223027000
renuka.munshi@gmail.com
Dr Devang Rana
V S General Hospital, Ahmedabad
V S General Hospital,
Room No.: 239, Second Floor, E-Ward, Neuro Trauma Building, Nr. Ellisbridge, Paldi,
Ahmedabad – 380006,
Gujarat, India Ahmadabad
Noble Hospital Institutional Ethics Committee, Pune
Approved
Rajarshee Chhatrapati Shahu Maharaj Government Medical College And Chhatrapati Pramila Raje Hospital, Kolhapur Institutional Ethics Committee 2, CPR Hospital Town Hall, Kolhapur
Approved
Redkar Hospital And Research Center, Institutional Ethics Committee, Pernem, Goa
Calculated dose will be diluted with formulation buffer as required to make 40 mL volume to be administered over a period of up to 2 hours as IV infusion.
Intervention
Dengue mAb 5 mg/kg
Calculated dose will be diluted with formulation buffer as required to make 40 mL volume to be administered over a period of up to 2 hours as IV infusion.
Intervention
Dengue mAb 7 mg/kg
Calculated dose will be diluted with formulation buffer as required to make 40 mL volume to be administered over a period of up to 2 hours as IV infusion.
Intervention
Dengue mAb 9 mg/kg
Calculated dose will be diluted with formulation buffer as required to make 40 mL volume to be administered over a period of up to 2 hours as IV infusion.
Comparator Agent
Placebo
Placebo is the formulation buffer containing all ingredients as Dengue mAb except for active ingredient of Dengue mAb. To be administered as 40 mL volume
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1. Adults aged 18-60 years, men, or women.
2. Participants who give written informed consent.
3. History of fever, presenting within 48 hours from onset.
4. Positive NS1 test (strip test / rapid test) or positive for PCR for acute dengue virus infection
5. Participants who are willing to be hospitalized for 4 days (96 hours) post study drug infusion, and to comply with other study protocol requirements including attendance at
scheduled follow-up visits.
ExclusionCriteria
Details
1.Patient meets criteria for Severe Dengue – severe plasma leakage leading to Dengue Shock Syndrome (DSS), fluid accumulation with respiratory distress, severe bleeding as assessed by clinician, severe organ involvement – AST/ALT >1000 U/L, impaired consciousness, and multi-organ dysfunction.
2.Hemoglobin < 10 g/dL, Absolute neutrophil count <500/mm3, Total leukocyte count <1500/mm3, and Platelet count <50,000/mm3
3.Known Hepatitis B, Hepatitis C and HIV infections.
4.Evidence or history of substance abuse including alcohol, or previous substance abuse within the last year.
5.Participation or planned participation in a study involving the administration of an investigational compound within the past one month or during this study period.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
1. Proportion of participants with causally related SAEs
2.Virological log reduction (VLR) of infective dengue virus as assessed by NS1 cell-based titration (NSET) assay
1. Throughout study duration of 180 days
2. 24 hours after administration of Dengue mAb
Secondary Outcome
Outcome
TimePoints
Proportion of participants with negative dengue virus isolation as assessed by NSET assay
at 24, 48, 72, 96 and 168 hours after administration of Dengue mAb
Proportion of participants with negative dengue virus isolation as assessed by NSET assay by serotype
at 24, 48, 72, 96 and 168 hours after administration of Dengue mAb
Proportion of participants with negative dengue virus isolation as assessed by NSET assay by baseline serostatus (primary or secondary dengue)
at 24, 48, 72, 96 and 168 hours after administration of Dengue mAb
Infective dengue VLR as measured by NSET
at 8, 48, 72, 96 and 168 hours after Dengue mAb administration
Target Sample Size
Total Sample Size="250" Sample Size from India="250"
This is a Phase 2, randomized, single-blind, parallel group, dose ranging, single dose study of Dengue mAb in adults with dengue fever with fever onset within last 48 hours. There will be total 5 groups, 4 different doses and a placebo control. The proposed doses to be studied are: 3 mg/kg, 5 mg/kg, 7 mg/kg, and 9 mg/kg. Total of 250 participants will be dosed and followed till Day 181 from dosing. Treatment allocation will be 1:1:1:1:1 to one of the 4 doses of Dengue mAb or to Placebo.
