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Trial registered on ANZCTR


Registration number
ACTRN12622000094774
Ethics application status
Approved
Date submitted
18/01/2022
Date registered
24/01/2022
Date last updated
24/01/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
INFINiTE-CV2 Phase I Trial: INterFeron type 1 Intra-Nasal gel Therapy for Early treatment of SARS-CoV2 (COVID-19)
Scientific title
Phase I ascending dose trial of Type 1 Interferon (IFN -1)/ Hyaluronic Acid formulation for the early treatment of SARS-CoV2 infection (COVID-19)
Secondary ID [1] 306236 0
Nil known
Universal Trial Number (UTN)
U1111-1273-3552
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 324962 0
Condition category
Condition code
Respiratory 322396 322396 0 0
Other respiratory disorders / diseases
Infection 322399 322399 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1 is single arm, ascending dose study for safety involving 20 patients.
- To assess whether nasal delivery of an Interferon (IFN -1)/ Hyaluronic Acid formulation is safe.
- To determine if there is a dose-dependent increase in side-effects through using an ascending dose structure.
- To assess the acceptability of the nasal spray for participants

A three-level ascending dose structure which administers 25%, 50%, 100% of the full dose of IFNß1a is used.
- Patients 1-5: 25% dose. 0.25ml/6M IU IFNß1a (Rebif 44) in 6.25ml of 3% micronized crosslinked sodium hyaluronate.
- Patients 6-10: 50% dose. 0.5ml/12M IU IFNß1a (Rebif 44) in 6ml of 3% micronized crosslinked sodium hyaluronate.
- Patients 11-20: 100% dose. 1ml/24M IU IFNß1a (Rebif 44) in 5.5ml of 3% micronized crosslinked sodium hyaluronate.
Route of administration: Nasal spray, 2 sprays both nostrils
Frequency of administration: Twice daily for five consecutive days

Patients will be virtually monitored daily a Clinical Trials Nurse to ensure compliance to the treatment regimen
Intervention code [1] 322641 0
Treatment: Drugs
Intervention code [2] 322642 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330160 0
Phase 1: To assess whether nasal delivery of an Interferon (IFN -1)/ Hyaluronic Acid formulation is safe.

Possible adverse events including local effects such as nasal bleeding, irritation or pain requiring unplanned hospital admission or treatment or any systemic effects such as allergy, autoimmune disease or any unplanned hospital admission.
Timepoint [1] 330160 0
Individual chart review and Safety assessment by DSMB after at 10 patients, 20 patients, and conclusion or in the event of SAE.

Standardised clinical assessment (may be performed virtually) will occur at baseline (pre-randomisation, 7 days, 2 weeks, 4 weeks post-randomisation).
Secondary outcome [1] 405084 0
To assess the acceptability of the nasal spray for participants via daily acceptability questionnaire (nasal spray evaluation questionnaire)
Timepoint [1] 405084 0
Individual chart review and Safety assessment by DSMB after at 10 patients, 20 patients, and conclusion or in the event of SAE.

Standardised clinical assessment (may be performed virtually) will occur at baseline (pre-randomisation, 7 days, 2 weeks, 4 weeks post-randomisation).

Eligibility
Key inclusion criteria
1. Males or females, aged greater than or equal to 18 years
2. Body mass index (BMI) less than or equal to 40.0 kg/m2 and greater than 15kg/m2
3. Diagnosis of SARS-CoV2 infection by PCR of nasopharyngeal swab, conducted by a NATA accredited laboratory (or international GLP equivalent) within the past 48hrs
4. enrolment within 96 hours from symptom onset (symptoms include: runny nose, headache, sore throat, fever or cough)
5. Willing and able to provide informed consent and comply with all study procedures and restrictions and the required visit schedule
6. Total Nasal Symptom Score at baseline less than 5
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age < 18 years old
2. Concurrent enrolment in other COVID-19 trials involving investigational agents administered within the last 30 days
3. Symptoms of pre-existing or intercurrent respiratory tract illness or infection such as pneumonia, bacterial or fungal sinusitis
4. Recent sinus surgery (last 2 weeks)
5. Suspected or confirmed convalescent COVID-19, defined as any previous positive test in the prior 4 weeks before the most recent positive test
6. Inability to operate a nasal spray device
7. Inability to provide verbal consent and written consent via eREDCAP
8. Known sensitivity/allergy to interferon
9. Current use of interferon for another indication
10. Major comorbidities increasing risk of study drug including i. Hematologic malignancy, ii. Advanced (stage 4-5) chronic kidney disease or dialysis therapy (eGFR< 29 ml/min), iii. Known history of ventricular arrhythmias iv. Current use of drugs that prolong the QT interval
11. Presence or history of substance abuse, including but not limited to cocaine, opioids and marijuana
12. Current use of systemic immunosuppressive therapy that cannot be suspended for duration of trial
13. Psychiatric disorders that are considered by the treating clinician to be a contraindication to interferon therapy. [i.e., those with mild or well-controlled psychiatric disorders (e.g., mild depression) may be included]
14. Any infection requiring IV antibiotics within 4 weeks of Screening, or oral antibiotics within 2 weeks of Screening.
15. Females who are pregnant, lactating, or who have a positive pregnancy test.
The effects of Gelferon on the unborn child and on the newborn baby are not known. Because of this, participants must not participate in the research if pregnant, trying to become pregnant, breastfeeding, or planning ovum donation.
16. Known or suspected hypersensitivity or contraindication to any of the ingredients in the study drug
17. Any condition that in the opinion of investigator is a contraindication to the study
18. Regular use of topical nasal spray or nasal douching

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Phase 1: data will be reported using descriptive statistics

The primary analysis of both primary and secondary endpoints will be according to modified intention to treat principles (all participants with data available for the endpoint will be analysed according to the treatment allocation, regardless of what treatment they received). No assumptions will be made about those with missing data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
Date of last participant enrolment
Anticipated
1/03/2022
Actual
Date of last data collection
Anticipated
31/03/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21497 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 36403 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 310583 0
Commercial sector/Industry
Name [1] 310583 0
IntraVital
Country [1] 310583 0
Australia
Primary sponsor type
Individual
Name
Dr Edmund Lau
Address
Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 311771 0
None
Name [1] 311771 0
Address [1] 311771 0
Country [1] 311771 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310189 0
Belberry
Ethics committee address [1] 310189 0
123 Glen Osmond Road, Eastwood SA 5063
Ethics committee country [1] 310189 0
Australia
Date submitted for ethics approval [1] 310189 0
Approval date [1] 310189 0
02/11/2021
Ethics approval number [1] 310189 0
[REGIS Application ID:2020ETH03123]

Summary
Brief summary
The INFINiTE-CV2 Phase I trial aims to assess whether nasal delivery of an Interferon (IFN -1)/ Hyaluronic Acid formulation is safe (phase 1) in COVID-19 infection.

This study is being performed to address an unmet urgent clinical need for a simple effective treatment for a pathogen of global health significance. It is hoped that this treatment is shown to be safe and effective with potential implications for both treatment and prevention of COVID-19.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116806 0
A/Prof Edmund Lau
Address 116806 0
Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown NSW 2050
Country 116806 0
Australia
Phone 116806 0
+61 295158806
Fax 116806 0
Email 116806 0
[email protected]
Contact person for public queries
Name 116807 0
Edmund Lau
Address 116807 0
Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown NSW 2050
Country 116807 0
Australia
Phone 116807 0
+61 295158806
Fax 116807 0
Email 116807 0
[email protected]
Contact person for scientific queries
Name 116808 0
Edmund Lau
Address 116808 0
Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown NSW 2050
Country 116808 0
Australia
Phone 116808 0
+61 295158806
Fax 116808 0
Email 116808 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only aggregate data will be available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.