RE: Covid Study2 Feb 2022 07:25
(AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces the results from the world's first COVID-19 characterisation study, which was a partnership between hVIVO, Imperial College London, the Vaccine Taskforce and Department of Health and Social Care (DHSC), and the Royal Free London NHS Foundation Trust. The results from this landmark study, show that a SARS-CoV-2 human challenge is safe in healthy young adults and provide detailed insights into the course of COVID-19 infection with potential positive public health implications.
As part of the characterisation study, researchers aimed to identify a dose of COVID-19 that caused a safe and reliable infection in unvaccinated volunteers with no prior SARS-CoV-2 infection. The results published today detail the outcome of the 36 healthy male and female volunteers aged 18-29 years which were infected with the original SARS-CoV-2 strain challenge virus. hVIVO clinicians closely monitored volunteers in a controlled quarantined setting and collected disease progression data to provide insights into COVID-19 infection. Volunteers will be followed up for 12 months after discharge from the quarantine facility.
The key clinical insights were as follows:
Viral load ("VL")
· 18 volunteers (50%) became infected with viral load (VL) rising steeply and peaking at ~five days post-inoculation
· No quantitative correlation was noted between VL and symptoms
Symptoms
· No serious symptoms
· Mild-to-moderate cold like symptoms were reported by 16 (88%) of 18 infected volunteers including a stuffy or runny nose, sneezing, and a sore throat. Some experienced headaches, muscle/joint aches, tiredness and fever
· Anosmia (lost or changed sense of smell) occurred in 13 (72% of infected) volunteers
Virus detection
· Average time from first exposure to viral detection and early symptoms (incubation period) was 42 hours
· Virus was detected earliest in the throat but at significantly greater levels in the nose;
o Virus detected in the throat on average after 40 hours
o Virus detected in the nose on average after 58 hours
· High levels of viable (infectious) virus was seen for approximately nine days post-inoculation, and up to a maximum of 12 days
· Modelling using the study data indicated that regular asymptomatic lateral flow testing ("LFT") would diagnose infection before 70-80% of infectious virus had been generated, thus if isolation was triggered would decrease community transmission to others
Importantly, no serious adverse events (SAEs) occurred, and the SARS-CoV-2 human challenge study model was shown to be safe and well tolerated in healthy young adults. With the characterisation study disease modelling data completed, and a COVID-19 Human Challenge Model now established, the Compan