COVID-19Phase 2NCT04854928
Study to Evaluate a Single Dose of LTX-109 in Subjects With COVID-19 (Coronavirus Disease 2019) Infection.
A Phase 2 study testing LTX-109 gel, 3% in people with COVID-19, run by Pharma Holdings AS at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- LTX-109 gel, 3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 3 May 2021to May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
ClinSmart Sweden AB
Uppsala, SE-752 37
Mahir Vazda
About this study
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.
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- LTX-109 gel, 3%, Placebo gel
- Keywords
- LTX-109, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo gelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| LTX-109 treatment | Experimental | Single Dose by Nasal application of LTX-109 gel 3%, 250 microliters in each nostril. Receives: Drug: LTX-109 gel, 3% |
| Placebo | Placebo comparator | Single Dose by Nasal application of placebo gel, 250 microliters in each nostril. Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: From baseline (pre-dose) to 2 hours (h) post-dose
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.
Measured: From dosing until 7 days after dose.
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).
Measured: From dosing until 7 days after dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start3 May 2021
- Primary completionFeb 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, Double-blind, Placebo-controlled Randomization 1:1, active to placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharma Holdings AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
- Investigators
- Christian Lütken, MD, Study director, Pharma Holdings AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854928
- Sponsor's protocol ID
- C21-109-09
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04854928
- Acronym / sponsor ID
- C21-109-09
- Conditions
- COVID-19
- Keywords
- LTX-109, COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pharma Holdings ASIndustry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Study start
- 3 May 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomised, Double-blind, Placebo-controlled Randomization 1:1, active to placebo
| Arm | Type | Receives |
|---|---|---|
| LTX-109 treatment | Experimental | Drug: LTX-109 gel, 3%Single Dose by Nasal application of LTX-109 gel 3%, 250 microliters in each nostril. |
| Placebo | Placebo comparator | Drug: Placebo gelSingle Dose by Nasal application of placebo gel, 250 microliters in each nostril. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | LTX-109 treatment |
| Placebo gelA 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. | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
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 safety and tolerability by frequency and seriousness of Adverse Events (AE)
Time frame: From dosing until 7 days after dose.
Assessment of safety and tolerability by intensity of AE
Time frame: From dosing until 7 days after dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Lütken, MD study director
Pharma Holdings AS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LTX-109 gel, 3% in people with COVID-19, run by Pharma Holdings AS at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Lütken, MD (+47 48 000 242, Christian.lutken@pharmaholdings.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.