The UK's world-class human challenge study gives us new information about SARS-CoV-2 cases that were mild in 36 healthy young volunteers who were not immune to the virus. People in the study group are thought to be major contributors to the pandemic. These studies, which are thought to be representative of ‘mild’ illness, allow for in-depth research into the factors that cause infection and the spread of the pandemic.
Imperial College London, the Vaccine Taskforce, the Department of Health and Social Care (DHSC), and the Royal Free London NHS Foundation Trust worked together on the Human Challenge Programme. Niche Science & Technology Ltd. helped run the project. The important study, which took place at a specialised unit at the Royal Free Hospital in London, shows that infecting volunteers for experiments can be done again and again, and the healthy young adults who took part did not have any severe symptoms. This paves the way for future studies to test new COVID-19 vaccines and medicines.
The collaborative study was the first to give detailed observations over the whole course of COVID-19 infection, from the first time the person was exposed to SARS-CoV-2 to the time their immune system beats the virus. SARS-CoV-2 were given a small amount of the virus through drops in the nose and were then closely watched by medical staff in a controlled setting for two weeks. As a result of their observations, researchers learned that symptoms appear quickly, about two days after being exposed to the virus. This is much earlier than previous predictions, which put it at five to six days. The amount of virus (viral load) found in swabs taken from people's noses or throats went up sharply after this time. As soon as an illness starts, the virus is most common in the nose and throat for about five days. The study showed that lateral flow tests (LFTs) are a good way to tell if an infectious virus is present and if a person is likely to spread the virus.
There hasn't been any peer review of the study yet; it was only released as a pre-print [1]. One of the most important things they found, though, was that the challenge infection model used to study SARS-CoV-2 did not show any severe symptoms or clinical issues. This is important because a lot of people were worried about the morality of giving fit people a virus whose health risks were not known [see comments on 2].
Eighteen of the volunteers got sick, and sixteen of them got mild to moderate cold-like symptoms, such as a sore throat, a stuffy or runny nose, and coughing. Some people got headaches, aches and pains in their muscles and joints, tiredness, and fevers. Thirteen sick volunteers said they lost their sense of smell, but in all but three cases, this went back to normal within 90 days. The data shows some interesting clinical insights, especially about how quickly the virus can spread, how much it sheds from the nose, and how useful lateral flow tests are. These findings could have effects on public health. High levels of the infectious virus were still detectable up to 9 days after the infection, and in some cases up to 12 days later. This supports the time limits for isolation that are recommended by most standards.
The authors point out that even though the model is a safe and accurate representation of an infection in young adults in the real world, the results may not be as useful because the sample size was small, the volunteers who were infected were not very diverse, and the follow-up time was short. The study used a virus strain from very early in the pandemic, from a hospitalised patient in the ISARIC4C study, before the Alpha version showed up. The smallest amount of virus that could infect people was given to them. This was about the same amount that could be found in a single droplet of nose fluid when the people were at their most contagious.
Interestingly, the study backs up the idea that LFTs can accurately tell when a person is not likely to infect others and can be allowed to come out of isolation. It also shows that twice-weekly rapid tests would allow diagnosis before 70–80% of the live virus was made during the infection. However, LFT tests were not as good at finding low amounts of virus at the beginning and end of an infection. The researchers say that the results also show how important it is to cover your mouth and nose when you're in a crowded, small area.
References
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