Active — Not RecruitingPhase 1

COVID-19 Omicron BA.5 Subvariant Dose Finding Infection Study

United Kingdom45 participantsStarted 2024-08-08

Plain-language summary

A phase 1, dose-finding open label clinical infection, safety and viral detection optimization in healthy volunteers immunologically experienced against SARS-CoV-2.

Who can participate

Age range18 Years – 40 Years

SexALL

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Inclusion criteria

✓. Aged 18-40 years at the time of enrolment.
✓. Evidence of having had at least one Covid-19 vaccine, with the last vaccination at least 3 months before enrolment.
✓. Positive serology for SARS-CoV-2 at screening OR evidence of prior infection with SARS-CoV-2 (Evidence will be assessed by a clinician and may include evidence of a positive PCR result, a photograph of a positive lateral flow on the volunteer's phone or anti-nucleocapsid positivity at any time).
✓. Body Mass Index (BMI) ≥18.5 kg/m2 and ≤28 kg/m2 at admission to the quarantine unit. The upper limit of BMI may be increased to ≤30kg/m2 at the PI's discretion, in the case of a physically fit muscular individual.

Exclusion criteria

✕. Willing and able to provide written informed consent for participation in the study.
✕. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner or any relevant health authority.
✕. Allow the investigator to register volunteer details with a confidential database (The Over-volunteering Protection Service) to prevent concurrent entry into clinical studies/trials.
✕. Agreement to refrain from blood donation during the course of the study.
✕0. For people of child bearing potential (POCBP): a willingness to practice continuous effective contraception (see below) from 4 weeks before admission to the quarantine unit until discharge from the quarantine unit, and negative pregnancy tests on screening (urine) and pre-enrolment admission days (urine and serum).
✕1. Agree to abstain from sexual activity or use effective contraception from the start of treatment with Paxlovid until 7 days after completing treatment with Paxlovid should they receive it. For people of child bearing potential (POCBP) taking the combined oral contraceptive pill, a willingness to use barrier contraception during treatment with Paxlovid and until completion of one menstrual cycle after completing Paxlovid treatment.
✕2. Able and willing (in the investigator's opinion) to comply with all study requirements.
✕3. No clinically relevant findings in medical history or on physical examination.

What they're measuring

Occurrence of solicited and unsolicited adverse events, including severe adverse events

Timeframe: Day 180

Selection of the optimal SARS-CoV-2 dose(s)

Timeframe: Day 14 or until discharge criteria is met

Trial details

NCT IDNCT06478420

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-10-31

View on ClinicalTrials.gov More SARS-CoV-2 Infection trials