Inclusion Criteria:
An informed consent document signed and dated by the participant and the Investigator.
Male or female, age between 18 and 30 years inclusive (at the time of the study consent)
Seronegative to the challenge virus SARS-CoV-2
Women of childbearing potential with a documented menstrual period within 28 days before the first dose (unless using a contraceptive method that suppressed menstruation as indicated in the study protocol) and willing and able to use contraception as described in the study protocol from 4 weeks before the scheduled date of viral challenge until 30 days after receipt of the final dose of study medication. Negative urine pregnancy test will be required at screening plus, on admission to the quarantine unit, a Negative serum beta human chorionic gonadotropin (β-hCG) is a required. Also a negative urinary pregnancy test prior to virus challenge is also required.
Men who are willing to use one of the contraception methods described in the study protocol, from the time of the date of viral challenge, until 90 days after receipt of the final dose of study medication.
In good health with no history of clinically significant medical conditions (as described in Exclusion criteria) that would interfere with subject safety, as defined by medical history, physical examination and routine laboratory tests, ECG, and Chest X-Ray* and determined by the Investigator at a screening evaluation and/or at admission to the Quarantine Unit.
Subjects will have a documented medical history either prior to entering the study and/or following medical history review with the study physician at screening
Using the QCOVID tool, an absolute risk of COVID-associated death of 1 in 250,000 (0.0004%) or less and COVID-associated hospital admission of 1 in 5000 (0.02%) or less), or alternative risk threshold at the discretion of the CI with advice from the DSMB
Exclusion Criteria:
Any potential subject who meet any of the criteria below will be excluded from participating in this study.
Clinical history 1. History or evidence of any clinically significant or currently active cardiovascular, (including thromboembolic events), respiratory, dermatological, gastrointestinal, endocrine, haematological, hepatic, immunological, rheumatological, metabolic, urological, renal, neurological, psychiatric illness. Specifically:
a) Subjects with any history of physician diagnosed and/or objective test confirmed asthma, chronic obstructive pulmonary disease, pulmonary hypertension, reactive airway disease, or chronic lung condition of any aetiology or who have experienced:
o Significant/severe wheeze in the past
Respiratory symptoms including wheeze which has ever resulted in hospitalisation
Known bronchial hyperreactivity to viruses b) History of thromboembolic, cardiovascular or cerebrovascular disease c) History or evidence of diabetes mellitus d) Any concurrent serious illness including history of malignancy that could interfere with the aims of the study or a subject completing the study. Basal cell carcinoma within 5 years of treatment or with evidence of recurrence is also an exclusion e) Migraine with associated neurological symptoms such as hemiplegia or vision loss. Cluster headache/migraine or prophylactic treatment for migraine f) History or evidence of autoimmune disease or known immunodeficiency of any cause.
g) Other major disease that, in the opinion of the Investigator, could interfere with a subject completing the study and necessary investigations.
h) Immunosuppression of any type. 2. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx, a clinically significant history of epistaxis (large nosebleeds) within the last 3 months, nasal or sinus surgery within 6 months of inoculation.
3. Clinically active rhinitis (including hay fever) or history of moderate to severe rhinitis, or history of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and/or requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of admission to quarantine.
4. History of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the PI.
5. History or presence of alcohol addiction, or excessive use of alcohol (average weekly intake in excess of 28 units alcohol; one unit being a half glass of beer, a small glass of wine or a measure of spirits).
6. Psychiatric illness including subjects with a history of depression and/or anxiety with associated severe psychiatric comorbidities, for example psychosis. Specifically,
a) Subjects with history of anxiety-related symptoms of any severity within the last 2 years if the Generalized Anxiety Disorder-7 score is ≥4 b) Subjects with a history of depression of any severity within the last 2 years if the Patient Health Questionnaire-9 score is ≥4
7. Current smokers or subjects who have smoked ≥5 pack years at any time [5 pack years is equivalent to one pack of 20 cigarettes a day for 5 years].
• Subjects who have smoked
