INFINiTE-CV2 Phase I Trial: INterFeron type 1 Intra-Nasal gel Therapy for Early treatment of SARS-CoV2 (COVID-19)

Phase 1

• Conditions: COVID-19; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12622000094774
• Lead Sponsor: Dr Edmund Lau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-24
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified