Study to test UNI91103 in adults with Covid-19 and no or only mild symptoms
- Conditions
- Covid-19MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-001036-25-DE
- Lead Sponsor
- ION therapeutics A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 330
1.The subject is male or female aged = 45 years.
2.The subject is able to understand and provide signed informed consent.
3.The subject is tested to confirm infection with SARS-CoV-2 by lateral flow antigen test or RT-PCR on a sample taken within 3 days before randomization.
4.The subject is either without symptoms or has one or more of the following symptoms: stuffy or runny nose, sore throat, loss of taste, loss of smell, or headache (to be entered in the FDA COVID-19 questionnaire). Conjunctivitis is also acceptable. None of the symptoms should have been present > 5 days.
5.Men whose sexual partners are women of childbearing potential (WOCBP) must agree to comply with one of the following contraception requirements from the time of first dose of screening until at least 30 days after the last dose of study medication:
a.Vasectomy with documentation of azoospermia.
b.Sexual abstinence (defined as refraining from heterosexual intercourse from the time of screening until at least 30 days after the last dose of study medication)
c.Male condom plus partner use of one of the contraceptive options below: contraceptive subdermal implant; intrauterine device of intrauterine system; oral contraceptive, either combine or progestogen alone; injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches.
The above is an all-inclusive list of those methods that meet the following definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigatory will determine what is consistent and correct use. The investigator is responsible for ensuring that patients understand how to properly use these methods of contraception.
6.WOCBP must agree to comply with one of the following contraception requirements from the time of screening until at least 30 days after the last dose of study medication:
a.Sexual abstinence (defined as refraining from heterosexual intercourse from the time of screening until at least 30 days after the last dose of study medication).
b.Use of one of the contraceptive options below plus use of a condom by male partner: contraceptive subdermal implant; intrauterine device or intrauterine system; oral contraceptive, either combined or progestogen alone; injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches.
c.Vasectomy of male partner with documentation of azoospermia.
The above is an all-inclusive list of those methods that meet the following definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. The investigator is responsible for ensuring that patients understand how to properly use these methods of contraception. Women of non-reproductive potential are defined as: a) Premenopausal females with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; documented bilateral oophorectomy. b) Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample will be required with simultaneous follicle stimulating hormone and estradiol levels tested locally and consistent with menopause [refer to local laboratory reference ranges
1.The subject has been enrolled in a study with niclosamide in the previous 6 months.
2.The subject is allergic to niclosamide or history of significant adverse reaction to niclosamide or related compounds, or to any of the excipient used.
3.The subject has an underlying condition that may interfere with intranasal administration of the investigational medicinal product (IMP), for example chronic ulcer(s) in the nose.
4.The subject has an acute or chronic condition that, as judged by the investigator, would jeopardize the safety of the participant.
5.The subject has a condition the investigator believes would interfere with the ability to provide consent, or comply with study instructions, or that might confound the interpretation of the study results.
6.6.Subjects with symptoms suggesting engagement of the lower respiratory tract or a systemic engagement such as cough, feeling feverish, chills, shivering, feeling hot, low energy, tiredness, body aches and pains, fatigue, shortness of breath, loss of appetite, nausea, vomiting, or diarrhea (to be entered in the FDA COVID-19 questionnaire), or other symptoms not mentioned in inclusion criteria 5.
7.The subject has an active or acute infection other than SARS-CoV-2.
8.The subject has used other investigational products the month prior to Day 1.
9.Antiviral medications and approved or experimental medications targeting COVID-19.
10.Another member of the same household recruited to this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of UNI91103 to prevent disease progression<br>To assess the safety of UNI91103<br>;Secondary Objective: To assess the efficacy of UNI91103 on development of symptoms of COVID-19<br>To assess UNI91103 on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on viral load <br>To assess the effect of UNI91103 on the spread of COVID-19 from the index case<br>;Primary end point(s): Change from baseline in symptoms through Day 10 defined as aggregated Food and Drug Administration (FDA) COVID-19 questionnaire score from baseline through Day 10 comparing UNI91103 vs placebo. <br>Safety of UNI91103 nasal spray as assessed by adverse events, vital signs, hematology, and clinical chemistry<br><br>;Timepoint(s) of evaluation of this end point: as defined in the end point and according to protocol assessments
- Secondary Outcome Measures
Name Time Method