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Study to Evaluate a Single Dose of LTX-109 in Subjects With COVID-19 (Coronavirus Disease 2019) Infection.

Primary Purpose

COVID-19

Status

Unknown status

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

LTX-109 gel, 3%

Placebo gel

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring LTX-109, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Willing and able to give electronically signed informed consent for participation in the study.
Male or female subject ≥18 years of age at screening.
Women of child-bearing potential have to agree to use an acceptable birth control method during participation in the investigation and a negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at Day 1 will be required.
A positive PCR test (polymerase chain reaction test) or antigen test for SARS-CoV-2. The positive result must be available no later than 4 days from initiation of symptoms, if any.
Duration of symptoms not exceeding 6 days prior to baseline/IMP administration (Day 1).
Access to a mobile phone or computer and ability to use the electronic diary application and to participate in web-based appointments.

Exclusion Criteria:

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.
Other upper respiratory tract infection with concomitant symptoms that can influence the results, such as sinusitis or tonsillitis.
Known allergy or hypersensitivity to the components of the IMP.
Current use of immunosuppressive therapy within the last 4 weeks prior to Day 1 and during the study.
Current use of nasally administered drugs within the last 2 weeks prior to Day 1 and during the study.
Vaccinated against COVID-19 or scheduled for vaccination within the study period.
Previous COVID-19 infection.
Any systemic anti-viral treatment within the last 4 weeks prior to Day 1 and during the study.
Pregnant, nursing or actively trying to conceive a child.
Inability to take medications nasally.
In situ nasal jewellery or open nasal piercings.
Planned treatment or treatment with another investigational drug within 30 days prior to Day 1. Subjects consented and screened but not dosed in previous Phase I studies are not excluded.
Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

Sites / Locations

ClinSmart Sweden ABRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LTX-109 treatment

Placebo

Arm Description

Single Dose by Nasal application of LTX-109 gel 3%, 250 microliters in each nostril.

Single Dose by Nasal application of placebo gel, 250 microliters in each nostril.

Outcomes

Primary Outcome Measures

Reduction in Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2 ) viral load in the deep nasal cavity as measured by the amount of live virus in the samples.

Assessment of viral load at baseline (pre-dose) and 2h post-dose to evaluate the effect of a single dose of LTX-109 nasal gel as compared to placebo. Reduction in SARS-CoV-2 viral load is measured by a standardised reverse transcription quantitative polymerase chain reaction (RT-qPCR) method and virus titration followed by cell viability assay to quantify the amount of live virus in the samples (Median Tissue Culture Infectious Dose [TCID50]). Viral load will be expressed as TCID50/mL.

Secondary Outcome Measures

Reduction in SARS-CoV-2 viral load in the anterior nasal cavity as measured by the amount of live virus in the samples.

Assessment of viral load at baseline (pre-dose) and 2h post-dose to evaluate the effect of a single dose of LTX-109 nasal gel as compared to placebo. Reduction in SARS-CoV-2 viral load is measured by a standardised RT-qPCR method and virus titration followed by cell viability assay to quantify the amount of live virus in the samples, TCID50. Viral load will be expressed as TCID50/mL.

Assessment of safety and tolerability by frequency and seriousness of Adverse Events (AE)

The Investigator will assess the seriousness of all AE according to the common definition of Serious Adverse Events (SAE). Frequency of AEs and SAEs will be summarised by treatment and overall.

Assessment of safety and tolerability by intensity of AE

The Investigator will assess the intensity of an AE on a 5 graded scale. Grade refers to the severity of the AE, from Grade 1 (mild) through Grade 5 (death).

Full Information

NCT ID

NCT04854928

First Posted

April 21, 2021

Last Updated

September 17, 2021

Sponsor

Pharma Holdings AS

Collaborators

CTC Clinical Trial Consultants AB

1. Study Identification

Unique Protocol Identification Number

NCT04854928

Brief Title

Study to Evaluate a Single Dose of LTX-109 in Subjects With COVID-19 (Coronavirus Disease 2019) Infection.

Official Title

A Double-blind, Placebo-controlled, Interventional Parallel Group Study to Evaluate the Antiviral Effect of a Single Nasal Application of LTX-109 3% Gel, in Comparison to Placebo Gel, in Subjects With COVID-19 Infection.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 3, 2021 (Actual)

Primary Completion Date

February 2022 (Anticipated)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharma Holdings AS

Collaborators

CTC Clinical Trial Consultants AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A Phase IIa, double-blind, placebo-controlled, randomised study designed to evaluate the effect, safety and tolerability of LTX-109 administered topically to the anterior nares in subjects with COVID-19 infection.

Detailed Description

A total of 60 subjects will be randomised to achieve approximately 46 completed and evaluable subjects. Subjects will be randomised 1:1 to one single dose of either active treatment or placebo. All potential study subjects will be contacted and invited to a screening video-call with the Investigator. Full verbal information will be given and the consent for participation in the study will be signed electronically. Eligible subjects will be visited twice at home by a study nurse on Day 1. During the first visit, one standard deep nose swab (one nostril) and one from the anterior part of the nose (both nostrils) will be collected. Symptom score will be assessed by the subject before dosing. The investigational medicinal product (IMP) will then be applied topically to both nostrils by the study nurse. The study nurse will come back to collect nasal swab samples 2 hours after administration of the IMP, using the same sampling procedure as for the baseline samples. Subjects will use an electronic diary for daily registrations of adverse events, concomitant medications and symptom score until Day 7. A follow-up phone contact will be performed 7 days after IMP administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

LTX-109, COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomised, Double-blind, Placebo-controlled Randomization 1:1, active to placebo

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LTX-109 treatment

Arm Type

Experimental

Arm Description

Single Dose by Nasal application of LTX-109 gel 3%, 250 microliters in each nostril.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Single Dose by Nasal application of placebo gel, 250 microliters in each nostril.

Intervention Type

Drug

Intervention Name(s)

LTX-109 gel, 3%

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo gel

Intervention Description

A Single dose of placebo 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.

Primary Outcome Measure Information:

Title

Reduction in Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2 ) viral load in the deep nasal cavity as measured by the amount of live virus in the samples.

Description

Time Frame

From baseline (pre-dose) to 2 hours (h) post-dose

Secondary Outcome Measure Information:

Title

Reduction in SARS-CoV-2 viral load in the anterior nasal cavity as measured by the amount of live virus in the samples.

Description

Assessment of viral load at baseline (pre-dose) and 2h post-dose to evaluate the effect of a single dose of LTX-109 nasal gel as compared to placebo. Reduction in SARS-CoV-2 viral load is measured by a standardised RT-qPCR method and virus titration followed by cell viability assay to quantify the amount of live virus in the samples, TCID50. Viral load will be expressed as TCID50/mL.

Time Frame

From baseline (pre-dose) to 2 hours (h) post-dose

Title

Assessment of safety and tolerability by frequency and seriousness of Adverse Events (AE)

Description

The Investigator will assess the seriousness of all AE according to the common definition of Serious Adverse Events (SAE). Frequency of AEs and SAEs will be summarised by treatment and overall.

Time Frame

From dosing until 7 days after dose.

Title

Assessment of safety and tolerability by intensity of AE

Description

The Investigator will assess the intensity of an AE on a 5 graded scale. Grade refers to the severity of the AE, from Grade 1 (mild) through Grade 5 (death).

Time Frame

From dosing until 7 days after dose.

Other Pre-specified Outcome Measures:

Title

Change in Symptom score for frequency of COVID-19 infection symptoms.

Description

Daily assessments of frequency of symptoms using a study-specific questionnaire with 10 questions/symptoms. Symptoms included are fever, cough, trouble breathing, loss of smell or taste, nasal congestion or runny nose, sore throat and/or difficulty swallowing, headache, muscle and/or joint pain, stomach-ache and/or nausea and diarrhoea. The frequency of each symptom will be graded by the Subject using a 5 graded scale from Grade 1 (None of the time) through Grade 5 (All of the time). For each symptom, the absolute and percent change from baseline to Day 7 will be calculated.

Time Frame

From pre-dose on Day 1 until Day 7.

Title

Change in Symptom score for intensity of COVID-19 infection symptoms.

Description

Daily assessments of intensity of symptoms using a study-specific questionnaire with 10 questions/symptoms. Symptoms included are fever, cough, trouble breathing, loss of smell or taste, nasal congestion or runny nose, sore throat and/or difficulty swallowing, headache, muscle and/or joint pain, stomach-ache and/or nausea and diarrhoea. The intensity of each symptom will be graded by the Subject using a 5 graded scale from Grade 1 (Not at all intense) through Grade 5 (Terribly intense). For each symptom, the absolute and percent change from baseline to Day 7 will be calculated.

Time Frame

From pre-dose on Day 1 until Day 7.

Title

Reduction in SARS-CoV-2 viral load in the deep nasal cavity as measured by qPCR.

Description

Time Frame

From baseline (pre-dose) to 2 hours (h) post-dose

Title

Reduction in SARS-CoV-2 viral load in the anterior nasal cavity as measured by qPCR.

Description

Time Frame

From baseline (pre-dose) to 2 hours (h) post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Willing and able to give electronically signed informed consent for participation in the study. Male or female subject ≥18 years of age at screening. Women of child-bearing potential have to agree to use an acceptable birth control method during participation in the investigation and a negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at Day 1 will be required. A positive PCR test (polymerase chain reaction test) or antigen test for SARS-CoV-2. The positive result must be available no later than 4 days from initiation of symptoms, if any. Duration of symptoms not exceeding 6 days prior to baseline/IMP administration (Day 1). Access to a mobile phone or computer and ability to use the electronic diary application and to participate in web-based appointments. Exclusion Criteria: 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. Other upper respiratory tract infection with concomitant symptoms that can influence the results, such as sinusitis or tonsillitis. Known allergy or hypersensitivity to the components of the IMP. Current use of immunosuppressive therapy within the last 4 weeks prior to Day 1 and during the study. Current use of nasally administered drugs within the last 2 weeks prior to Day 1 and during the study. Vaccinated against COVID-19 or scheduled for vaccination within the study period. Previous COVID-19 infection. Any systemic anti-viral treatment within the last 4 weeks prior to Day 1 and during the study. Pregnant, nursing or actively trying to conceive a child. Inability to take medications nasally. In situ nasal jewellery or open nasal piercings. Planned treatment or treatment with another investigational drug within 30 days prior to Day 1. Subjects consented and screened but not dosed in previous Phase I studies are not excluded. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian Lütken, MD

Phone

+47 48 000 242

Christian.lutken@pharmaholdings.no

First Name & Middle Initial & Last Name or Official Title & Degree

Johnny Ryvoll, MBA, B.Sc..

Phone

+47 90 13 02 43

ryvoll@pharmaholdings.no

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Lütken, MD

Organizational Affiliation

Pharma Holdings AS

Official's Role

Study Director

Facility Information:

Facility Name

ClinSmart Sweden AB

City

Uppsala

ZIP/Postal Code

SE-752 37

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mahir Vazda

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study to Evaluate a Single Dose of LTX-109 in Subjects With COVID-19 (Coronavirus Disease 2019) Infection.

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