| CTRI Number |
CTRI/2022/02/039887 [Registered on: 01/02/2022] Trial Registered Prospectively |
| Last Modified On: |
31/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to Evaluate a Single Dose of LTX-109 in Subjects With COVID-19 (Coronavirus Disease 2019) Infection |
|
Scientific Title of Study
|
A double blind, placebo controlled intervention study to evaluate the antiviral effect of a single nasal dose with LTX-109 3 percent gel,compared to placebo gel, in individuals with COVID-19 infection. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C21-109-09, Version 3.2 dated 21-Dec-2021 |
Protocol Number |
| NCT04854928 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annappa Kamath |
| Designation |
Senior Solutions Consultant Director |
| Affiliation |
Parexel International Clinical Research Private Limited |
| Address |
CoWrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU
Bangalore
KARNATAKA
560103
India |
| Phone |
8067169360 |
| Fax |
|
| Email |
Annappa.Kamath@parexel.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annappa Kamath |
| Designation |
Senior Solutions Consultant Director |
| Affiliation |
Parexel International Clinical Research Private Limited |
| Address |
CoWrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU
Bangalore
KARNATAKA
560103
India |
| Phone |
8067169360 |
| Fax |
|
| Email |
Annappa.Kamath@parexel.com |
|
|
Source of Monetary or Material Support
|
| Pharma Holdings AS, Killengreensgt.2-8, 9008, Tromso, Norway |
|
|
Primary Sponsor
|
| Name |
Pharma Holdings AS |
| Address |
Killengreensgt.2-8, 9008, Tromso, Norway |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Parexel International Clinical Research Private Limited |
CoWrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA |
|
|
Countries of Recruitment
|
Sweden
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nirav Chandulal Bhalani |
Rhythm Heart Institute- A Unit of Synergy Lifecare Pvt. Ltd |
Rhythm Heart Institute- A Unit of Synergy Lifecare Pvt. Ltd., Clinical Research Department Room No. 101, Near Siddharth Bunglows, Sama-Savli Road, 390022
Vadodara
GUJARAT |
91-265-2541006
trial@rhythmheart.com |
| Dr Namdev Jagtap Sakharam |
VishwaRaj Hospital |
VishwaRaj Hospital, 4th Floor, Clinical Research Department, Pune Solapur Road, near Loni Kalbhor railway station, Kadamwakwasti– 412201
Pune
MAHARASHTRA |
2067606060
drjagtapdev@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee MAEER’S Vishwaraj Hospital, Gate no 499, Kadamwakwasti, Loni Kalbhor, Solapur Road, Pune – 412201, Maharashtra |
Approved |
| Rhythm Heart Institute Ethics Committee, Near Siddharth Bunglows, Sama-Savli Road, Vadodara -390022 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Drug Product |
A Single dose of LTX-109 gel will be applied topically to both nostrils by a qualified health professional. A large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.
1. Dose – Single dose of LTX-109 3%
2. Frequency – Single dose at Day 1.
3. Route of Administration – Nasal administration.
4. Duration of Therapy - One single dose of the IMP(LTX-109 3%), approximately 250 µL, in each nostril |
| Comparator Agent |
Placebo |
1. Dose – Single dose of placebo gel
2. Frequency – Single dose at Day 1.
3. Route of Administration – Nasal administration.
4. Duration of Therapy - One single dose of the Placebo gel, approximately 250 µL, in each nostril |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Willing and able to give signed informed consent for participation in the study
2)Male or female subject greater than or equal to 18 years of age at screening
3) Women of child-bearing potential
-Have to agree to use an acceptable birth control method during participation in the investigation
-A negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at Day 1 will be required. Country specific India: Serum pregnancy test will be used instead of urine
4) Asymptomatic or mildly infected COVID-19 patients as per Indian guidelines for Indian sites. NIH criteria will be used for Sweden
5) Duration of symptoms not exceeding 6 days prior to baseline/IMP administration (Day 1)
6) A positive RT-PCR test no older than 72 hours for SARS-CoV-2. The positive result must be available no later than 6 days from initiation of symptoms, if any |
|
| ExclusionCriteria |
| Details |
1) History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study
2)Other upper respiratory tract infection with concomitant symptoms that can influence the results, as judged by the Investigator
3)Known allergy or hypersensitivity to the components of the IMP
4) Current use of immunosuppressive therapy within the last 4 weeks prior to Day 1 and during the study
5) Current use of nasally administered drugs within 1 day prior to Day 1 and during the study
6) Vaccinated against COVID-19 or scheduled for vaccination within the study period
7) Previous COVID-19 infection
8) Moderate or severe COVID-19 infection as per guidelines
9)Any systemic anti-viral treatment within the last 4 weeks prior to Day 1 and during the study
10) Pregnant, nursing or actively trying to conceive a child
11) Inability to take medications nasally
12) In situ nasal jewellery or open nasal piercings
13) Planned treatment or treatment with another investigational drug within 30 days prior to Day 1
14) Subjects consented and screened but not dosed in previous Phase I studies are not excluded
15) Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in SARS-CoV-2 viral load, based on the deep nasal swab sample as measured by a standardised RT-qPCR method after virus cultivation. Viral load will be expressed as relative amount of virions in samples after
treatment compared to before treatment (set to 100) |
From baseline (pre-dose) to 2 hours (h) post-dose] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Reduction in SARS-CoV-2 viral load, based on the anterior nasal swab sample as measured by a standardised RT-qPCR method after virus cultivation. Viral load will be expressed as relative amount of virions in samples after treatment compared to before treatment (set to 100)
2)Frequency, intensity and seriousness of AEs |
1) from baseline (pre-dose) to 2 h post-dose
2) From dosing until 7 days after dose |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="50"
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 2 |
|
Date of First Enrollment (India)
|
14/02/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/05/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a double-blind, placebo-controlled, interventional parallel group study with the aim to evaluate the use of LTX-109 nasal gel for treatment of Coronavirus disease 2019 (COVID-19) infection by application to the nasal cavity. Subjects will be randomised 1:1 to one single dose of either active treatment (LTX-109 3% hydrogel) or matching placebo. |