None listed
Conditions
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.
Interventions
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/6
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
Sponsors
Dr Edmund Lau
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed