In a few short months the SARS-CoV-2 coronavirus has spread throughout the world. The virus can infect the respiratory (breathing) system, causing fever and a continuous cough, and can develop into pneumonia.
There is currently no vaccine against the virus or approved specific treatment for COVID-19 (the disease caused by the virus), although remdesivir has been authorized for emergency use by the US FDA pending formal approval.
Clinical trials are urgently needed to determine the effectiveness of treatments and vaccines for COVID-19. In our blog for Clinical Trials Day 2020 we look at a selection of the ongoing COVID-19-related trials that have been registered at the ISRCTN registry so far this year.
The World Health Organization (WHO) has organized the international SOLIDARITY trial to compare untested treatments for COVID-19 with each other. The study treatments include drugs that are currently used to treat other conditions such as the antivirals remdesivir and lopinavir plus ritonavir, the antimalarials chloroquine and hydroxychloroquine, and interferon-beta, which is used to treat multiple sclerosis.
In the UK the RECOVERY trial is assessing a similar selection of possible treatments at many hospitals. At the time of writing RECOVERY is the world’s biggest trial of drugs to treat COVID-19 patients. Like SOLIDARITY, RECOVERY has an adaptive trial design, which means that new treatments are being added to the trial as evidence emerges.
Currently the treatments being tested include lopinavir plus ritonavir and hydroxychloroquine as mentioned above, as well as corticosteroids (typically used to reduce inflammation), azithromycin (a commonly used antibiotic), and tocilizumab (a treatment for rheumatoid arthritis).
Hydroxychloroquine is also being tested separately in the PRINCIPLE study at GP practices in England. This study is specifically recruiting people who are at a higher risk from infection with the virus, such as people aged 65 and over, or those known to have one of the following conditions: a weakened immune system, heart disease, asthma or lung disease, diabetes, mild hepatic impairment, or stroke.
Vaccines are the most cost-effective way of controlling outbreaks and the international community has stepped up its efforts towards developing one against COVID-19. The COV001 and COV002 studies based in Oxford (UK) are testing a new vaccine on healthy volunteers to see if they can be protected from COVID-19. They will also provide valuable information on the safety of the vaccine and its ability to generate good immune responses against the virus.
COVID-19 has placed a huge burden on intensive care units as many patients experience breathing problems and require a ventilator. The RECOVERY Respiratory Support (Recovery-RS) study is testing treatments that aim to prevent people from needing to go on a ventilator.
Patients are randomly allocated to receive oxygen either through a tight-fitting mask (continuous positive airway pressure [CPAP]) or blown up their nose by a machine (high-flow nasal oxygen [HFNO]), or through a normal oxygen mask. Both CPAP and HFNO are already used routinely in the NHS for other conditions.
Having a rapid bedside test for COVID-19 may allow doctors to identify infected patients more quickly and stop the virus from spreading in hospitals. It may also identify those who are not infected much earlier, allowing them to be taken out of isolation rooms and sent home sooner, easing pressure on the healthcare system. The aim of the CoV-19POC study is to find out whether using a new rapid test for COVID-19 leads to earlier decision making and better care for patients.
Frontline healthcare workers, such as those in the emergency department, are at high risk of contracting COVID-19 due to their close contact with patients who may have the virus. The HEROs study taking place at five hospitals in Canada aims to find out whether taking hydroxychloroquine before and during exposure to patients reduces their risk of COVID-19 infection.
The COVVA study in Spain is looking at the effects on healthcare workers of wearing personal protective equipment (PPE), such as N95 respirators and FFP2 face masks, to investigate whether their working conditions can be improved. The healthcare workers are asked about the presence of problems such as headache and skin lesions after working in isolation areas.
Impact on other conditions
The COVER study is an international study aiming to collect information on how the COVID-19 pandemic is affecting the medical care of patients with artery and vein (vascular) conditions. This is an important question as patients with such health problems typically have many other health issues and/or are elderly. This makes them more likely to develop life-threatening complications.
The UKOSS: Pandemic COVID-19 in pregnancy study is collecting information about all pregnant women admitted to hospital with COVID-19 in the UK to investigate the effects of the infection and treatments on the mother and baby.
Stressful major events such as a global pandemic can disrupt sleep. However, by intervening early, this may be stopped from becoming a long-term problem. The Sleep COVID-19 study is testing an early online treatment, in the form of sleep education, for people who have recently reported having poor sleep.
The stay-at-home message
The ISRCTN registry supports global research on COVID-19 by giving priority to prompt registration and reporting of COVID-19-related studies. All registered studies are made available worldwide through the WHO’s International Clinical Trials Registry Platform (ICTRP).
To find out more about what ICTRP and its network of registries are doing to make information on clinical research accessible during the pandemic, take a look at this blog from the WHO and this blog by the ISRCTN Database Manager.