Screening Protocol for a Dose Finding Human Experimental Infection Study in Healthy Subjects Using a GMP-produced SARS-COV-2 Wild Type Strain

Imperial College London1 site in 1 country36 target enrollmentDecember 15, 2020

ConditionsCovid19

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Covid19
Sponsor: Imperial College London
Enrollment: 36
Locations: 1
Primary Endpoint: Participants Enrolled
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this screening protocol is to assess volunteers for their potential eligibility to participate in a dose finding human experimental infection study in healthy subjects using a GMP-produced SARS-CoV-2 wild type strain

Detailed Description

Recruitment will be done through a number of channels: * Approved advertising, including social medial * hVIVO volunteer database * Referral * Organic search, i.e. where the volunteer has learned of this study by doing a Google search or through friends or family rather than due to any advertising Following Research Ethics Committee approval of the full study, screened subjects who confirm their willingness to participate in the SARS-CoV-2 human infection challenge characterization study will be invited to consider the study-specific PIS-ICF and enter the final study consenting process. The number of subjects who are to be recruited will depend on specific sample-size requirements for the SARS-CoV-2 human infection characterization study.

Registry

clinicaltrials.gov

Start Date

December 15, 2020

End Date

July 9, 2021

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Imperial College London

Responsible Party

Sponsor

Eligibility Criteria

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
•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.
•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.