Clinical Trials Logo

Clinical Trial Summary

A phase I, experimental dose finding, open label, clinical infection, safety and viral detection optimisation in healthy volunteers aged 18-30, previously infected with SARS-CoV-2.


Clinical Trial Description

This is a phase I dose escalation challenge study in which increasing titres of wild-type SARS-CoV-2 (1x10^1 TCID_50, 1x10^2TCID_50 and 1x10^3TCID_50) will be administered intranasally to different groups of volunteers in order to achieve a 50% (+/-10%) attack rate as determined by quantitative live viral detection and/or qPCR detection in naso-pharyngeal secretions at two consecutive 12 hourly time points (at least 24 hours after inoculation). A Data Safety Monitoring Board (DSMB) will review safety and quantitative virology at each dose level and will recommend continuation, dose escalation or de-escalation based on emergent data. Rescue treatment with a single infusion of 1200mg intravenous monoclonal antibody cocktail (REGN-COV2) will commence immediately after symptoms, signs or investigations suggestive of COVID-19. Once the optimal dose of wildtype SARS-CoV-2 has been identified, further challenge infections in group 2 may proceed without REGN-COV2 treatment (following DSMB review of infection rate, viral load and clinical data). Volunteers will remain in isolation rooms within the clinical trials unit for a minimum of 14 days post inoculation and until demonstration of the absence of live virus in two sequential samples. Volunteers will be recruited from the Thames Valley region with screening and outpatient follow up visits at the Clinical Centre for Vaccinology and Tropical Medicine. They will be challenged and admitted for a quarantine period within rooms with appropriate ventilation to prevent spread of infection (negative pressure rooms or positive pressure ventilation lobby) located at Oxford University Hospitals NHS trust or Oxford Clinical Research Facility (OxCRF) depending on bed availability. It is planned that a total of up to 64 participants (44 with option of an additional 20) will be enrolled across 2 groups. This study will be funded by the Wellcome Trust. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04864548
Study type Interventional
Source University of Oxford
Contact Volunteer Recruitment Co-ordinator
Phone 07990431010
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date May 2021
Completion date November 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04332666 - Angiotensin-(1,7) Treatment in COVID-19: the ATCO Trial Phase 2/Phase 3
Active, not recruiting NCT04515147 - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Phase 2
Not yet recruiting NCT04779138 - Increasing Vaccine Uptake in Underresourced Public Housing Areas N/A
Completed NCT04818164 - Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
Completed NCT04690413 - NOWDx Test for the Detection of Antibodies to COVID-19 N/A
Recruiting NCT04530448 - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Phase 4
Completed NCT04572399 - UVA Light Device to Treat COVID-19 N/A
Recruiting NCT04610567 - Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease With Methotrexate Associated to LDL Like Nanoparticles (Nano-COVID19) Phase 1/Phase 2
Recruiting NCT04551911 - Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19 Phase 2
Recruiting NCT04581954 - Inflammatory Signal Inhibitors for COVID-19 (MATIS) Phase 1/Phase 2
Not yet recruiting NCT04453774 - At Home Monitoring for Patients With Covid19 N/A
Recruiting NCT04371978 - Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19 Phase 3
Completed NCT04556149 - imPulseā„¢ Una Full-spectrum, Over Clothing E-stethoscope
Recruiting NCT03680274 - Lessening Organ Dysfunction With VITamin C Phase 3
Withdrawn NCT04605926 - A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19 Phase 3
Recruiting NCT04638673 - NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis Phase 2
Active, not recruiting NCT04706416 - N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19) Phase 1
Recruiting NCT04542343 - COVID-19 Risk Reduction Among African American Parishioners N/A
Completed NCT04382040 - A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19 Phase 2
Recruiting NCT04390191 - Early CPAP in COVID-19 Confirmed or Suspected Patients N/A