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

NCT04854928 | Unknown Phase 2

• 1 other identifier: C21-109-09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

LTX-109; COVID-19

Outcome Measures

Primary Outcomes (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.

  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.

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

Secondary Outcomes (3)

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

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

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

  From dosing until 7 days after dose.

• Assessment of safety and tolerability by intensity of AE

  From dosing until 7 days after dose.

Other Outcomes (4)

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

  From pre-dose on Day 1 until Day 7.

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

  From pre-dose on Day 1 until Day 7.

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

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

Study Arms (2)

LTX-109 treatment

EXPERIMENTAL

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

Drug: LTX-109 gel, 3%

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo gel

Interventions

LTX-109 gel, 3% DRUG

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.

LTX-109 treatment

Placebo gel DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharma Holdings AS: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (1)

ClinSmart Sweden AB

Uppsala, SE-752 37, Sweden

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Christian Lütken, MD

  Pharma Holdings AS

  STUDY DIRECTOR

Central Study Contacts

Christian Lütken, MD

CONTACT

+47 48 000 242; Christian.lutken@pharmaholdings.no

Johnny Ryvoll, MBA, B.Sc..

CONTACT

+47 90 13 02 43; ryvoll@pharmaholdings.no

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 22, 2021
• Study Start: May 3, 2021
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)