Open Orphan, a global CRO (contract research organization), the Imperial College of London, the vaccines task force of Britain, and hVIVO (the clinical company affiliated with Open Orphan) collaboratively conducted the first-ever human trial (known as a “human challenge study”) with COVID-19.
The research began in February of 2021. Thirty-six volunteers were purposefully infected with the original strain of the COVID-19 virus (SARS-CoV-2) and monitored within a quarantined environment.
As summarized by CNBC, the objective of the trial was “to advance research into the disease,” and directors commented on February 2 that they found it to be “safe in healthy young adults.”
It is important to note that the study is still in the pre-print phase, which means it has not yet been peer-reviewed, a prerequisite for publication within most scientific journals.
Volunteers were administered nasal drops of COVID-19 in a “safe and controlled environment” at the Royal Free Hospital in London, reported Imperial College. The volunteers were unanimously healthy and able, low-risk, and unvaccinated. Physicians closely monitored all.
According to Reuters, the volunteers will continue to be surveilled for 12 months post-discharge.
Imperial Professor Christopher Chiu stated that no health concerns were discovered among the volunteers and that clues as to how COVID-19 operates within the body resulted.
“Our study reveals some very interesting clinical insights, particularly around the short incubation period of the virus, extremely high viral shedding from the nose, as well as the utility of lateral flow tests, with potential implications for public health,” Chiu reflected via the Imperial College news portal.
The study claims that, during testing, half of the participants who were given the virus in low-dosage form did not contract the virus. Some who did contract the virus were asymptomatic. Most exhibited mild signs such as sore throat and cough.
Open Orphan hopes that the human trials will allow researchers to test different treatments and vaccine options, in real-time, on real patients. Labs and simulation can only accomplish so much, the organization contends. Human trials could open the door to further advancements organized to combat the virus.
On the contrary, not everyone celebrates the purported outcomes of the experimentation.
The Advisory Board, a formal network of over 4,500 research organizations, conveyed a less-than-impressed reaction from Seema K. Shah, J.D., a bioethicist at Northwestern University: “In my mind, it’s still not entirely clear whether these studies are ethically justified, and I’m waiting to see what else they’ve found.”
Director of the Center for Population-Level Bioethics at Rutgers University Nir Eyal emphasized to the scientific journal, Nature, the importance of keeping study volunteers uncompensated: “I think in this study, ensuring a high level of public trust is important, and I would advise researchers not to attract volunteers through high payments. This would have the advantage of making sure that the study doesn’t prey on the poor.”
