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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04854928
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : September 20, 2021
Sponsor:
Collaborator:
CTC Clinical Trial Consultants AB
Information provided by (Responsible Party):
Pharma Holdings AS

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: LTX-109 gel, 3% Drug: Placebo gel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, Double-blind, Placebo-controlled Randomization 1:1, active to placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 3, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LTX-109 treatment
Single Dose by Nasal application of LTX-109 gel 3%, 250 microliters in each nostril.
Drug: LTX-109 gel, 3%
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.

Placebo Comparator: Placebo
Single Dose by Nasal application of placebo gel, 250 microliters in each nostril.
Drug: Placebo gel
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 Measures :
  1. 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. [ Time Frame: From baseline (pre-dose) to 2 hours (h) post-dose ]
    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 :
  1. Reduction in SARS-CoV-2 viral load in the anterior nasal cavity as measured by the amount of live virus in the samples. [ Time Frame: From baseline (pre-dose) to 2 hours (h) post-dose ]
    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.

  2. Assessment of safety and tolerability by frequency and seriousness of Adverse Events (AE) [ Time Frame: From dosing until 7 days after dose. ]
    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.

  3. Assessment of safety and tolerability by intensity of AE [ Time Frame: From dosing until 7 days after dose. ]
    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).


Other Outcome Measures:
  1. Change in Symptom score for frequency of COVID-19 infection symptoms. [ Time Frame: From pre-dose on Day 1 until Day 7. ]
    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.

  2. Change in Symptom score for intensity of COVID-19 infection symptoms. [ Time Frame: From pre-dose on Day 1 until Day 7. ]
    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.

  3. Reduction in SARS-CoV-2 viral load in the deep nasal cavity as measured by qPCR. [ Time Frame: From baseline (pre-dose) to 2 hours (h) post-dose ]
    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 qPCR. Viral load will be expressed as log10 RNA copies per 1000 cells.

  4. Reduction in SARS-CoV-2 viral load in the anterior nasal cavity as measured by qPCR. [ Time Frame: From baseline (pre-dose) to 2 hours (h) post-dose ]
    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 qPCR. Viral load will be expressed as log10 RNA copies per 1000 cells.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to give electronically signed informed consent for participation in the study.
  2. Male or female subject ≥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 and a negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at Day 1 will be required.
  4. 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.
  5. Duration of symptoms not exceeding 6 days prior to baseline/IMP administration (Day 1).
  6. Access to a mobile phone or computer and ability to use the electronic diary application and to participate in web-based appointments.

Exclusion Criteria:

  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, such as sinusitis or tonsillitis.
  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 the last 2 weeks 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. Any systemic anti-viral treatment within the last 4 weeks prior to Day 1 and during the study.
  9. Pregnant, nursing or actively trying to conceive a child.
  10. Inability to take medications nasally.
  11. In situ nasal jewellery or open nasal piercings.
  12. 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.
  13. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854928


Contacts
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Contact: Christian Lütken, MD +47 48 000 242 Christian.lutken@pharmaholdings.no
Contact: Johnny Ryvoll, MBA, B.Sc.. +47 90 13 02 43 ryvoll@pharmaholdings.no

Locations
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Sweden
ClinSmart Sweden AB Recruiting
Uppsala, Sweden, SE-752 37
Principal Investigator: Mahir Vazda         
Sponsors and Collaborators
Pharma Holdings AS
CTC Clinical Trial Consultants AB
Investigators
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Study Director: Christian Lütken, MD Pharma Holdings AS
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Responsible Party: Pharma Holdings AS
ClinicalTrials.gov Identifier: NCT04854928    
Other Study ID Numbers: C21-109-09
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pharma Holdings AS:
LTX-109
COVID-19
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases