COVID-19 SARS-CoV-2 Screening Protocol

NCT04740320 | Completed Results

• 1 other identifier: 20IC6378
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Keywords

COVID19; Coronavirus; Coronavirus disease 19; SARS-COV-2; Healthy volunteer; human challenge

Outcome Measures

Primary Outcomes (1)

• Participants Enrolled

  Number of participants enrolled in main study

  6 months

Study Arms (1)

Healthy Volunteers

Volunteers asked to register details on a SARS-CoV-2 specific web page UKcovidchallenge.com. They will be contacted with a short webform questionnaire to be performed prior to a follow-up telephone questionnaire or will be asked to complete a telephone questionnaire. If inclusion/exclusion criteria are met, appointment for a screening visit will be scheduled. Screening appointments will be conducted at hVIVO. Written consent for screening will be obtained prior to any history-taking, examination or tests are carried out. Medical history will be requested from GP to assess suitability. Once the SARS-CoV-2 characterization study is approved, potential participants will be given the study specific PIS detailing the full study and experimental procedures. The opportunity to discuss further and ask questions will be available prior to booking a study visit.

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers aged 18-30

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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.
• \. History of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the PI.
• \. 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).
• \. 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
• \. 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 \<5 pack years - at any time in the 3 months prior to admission to the quarantine unit they have used tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch) or electronic cigarettes.

Sponsors & Collaborators

• Imperial College London: lead
• Hvivo: collaborator

Study Sites (1)

hVIVO Services Ltd, QMB Bioenterprise building

London, E1 2AX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples of tissue, cells and fluids will be stored according to Imperial College London and hVIVO SOPs as appropriate. Samples will be pseudoanonymised with participant identification numbers only and the anonymisation key kept in a separate locked location accessible only to the hVIVO clinical study team. Samples may be used for further assays or in other ethically approved studies. Samples and data may be shared with UK and international collaborators in studies that have been approved by local ethics committees and subject to a valid Materials Transfer Agreement. At the end of the study any remaining samples will be either destroyed, transferred to the sponsor or subject to consent, transfer to and maintained under hVIVOs HTA licenses.

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Imperial College London

polly.fox@imperial.ac.uk

+442083831284

Study Officials

• Chris Chiu

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 5, 2021
• Study Start: December 15, 2020
• Primary Completion: June 23, 2021
• Study Completion: July 9, 2021
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)