Covid19
Conditions
Keywords
COVID19, Coronavirus, Coronavirus disease 19, SARS-COV-2, Healthy volunteer, human challenge
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.
Interventions
None listed
Sponsors
Hvivo
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. An informed consent document signed and dated by the participant and the Investigator. 2. Male or female, age between 18 and 30 years inclusive (at the time of the study consent) 3. Seronegative to the challenge virus SARS-CoV-2 4. 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. 5. 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. 6. 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. 7. 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 8. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Enrolled | 6 months | Number of participants enrolled in main study |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Healthy Volunteers | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 36 Participants | — |
| Age, Continuous | 21.8 age of participants STANDARD_DEVIATION 2.69 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 36 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 26 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Participants Enrolled
Number of participants enrolled in main study
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Volunteers | Participants Enrolled | 36 Participants |