COVID-19 Clinical Trials: Vaccines, Tests and Other Conditions

In our Blog For Clinical Trials Day 2020, we summarized the COVID-19 studies that had been recorded so far at ISRCTN Registry. A year later and there are now more 170 COVID-19 studies recorded. In the first part from this blog, we looked at the results of Platform tests and a selection of drug treatment reused tests launched since. In this blog, we review the results of vaccine trials discussed in our first blog and studies focusing on testing and the impact of COVID-19 on other conditions.

Vaccines

Several vaccines have been developed for COVID-19 around the world. The vaccine developed by the University of Oxford and AstraZeneca has been tested in Phase I / II, Phase II / III and Phase III studies and results confirmed that the vaccine was effective.

The AstraZeneca vaccine has been approved for use in many countries, including the United Kingdom. Mass vaccination against COVID-19 began in the UK in early December 2020 and will likely continue until mid-2021. The AstraZeneca vaccine is currently being tested in a Phase II study in children.

Doctor in medical mask injecting young man with vaccine

Doctor in medical mask injecting young man with vaccine

© Studio Romantic / stock.adobe.com

Other candidate vaccines are being tested in the COVAC1, CROWNED and SET 2 testing. There are also vaccines in development from Valneva and the University of Queensland. The safety of all vaccines is monitored by the VAC4COVID study initially launched in the United Kingdom and by the ZVAC study in Switzerland.

the VOC-COMPARE study compares the immunogenicity of two doses of the AstraZeneca and Valneva vaccines, while the Com-VOC and Com-COV2 studies compare different vaccine combinations (eg AstraZeneca and Pfizer-BioNTech vaccines) for priming and booster doses, as well as 4 and 12 week intervals between doses.

The duration of protection for current vaccines is unknown and additional booster doses may be required in 9 to 12 months, which may coincide with the seasonal influenza vaccination. Administering COVID-19 and influenza vaccines at separate appointments will lead to significant logistical challenges, so the ComFluCOV The trial determines the safety and immune response when the two vaccines are given to different arms at the same appointment.

Swab test for COVID-19

Swab test for COVID-19

© Laci Perenyi / photo alliance

Trial

The tests have been shown to be essential in containing the spread of the virus. the results of CoV-19POC A study has shown that a new point-of-care test for COVID-19 provides faster results and may improve infection control measures and patient flow compared to centralized laboratory PCR testing.

In England and Wales, infection rates in nursing homes have reached up to 80% and death rates up to 30-50%. the VIVALDI is performing repeated testing (antigen and antibody) with staff and residents of health facilities CONTACT A feasibility study investigates whether portable digital devices can help improve contact tracing in nursing homes.

Now schools have reopened in the UK containing the virus poses a particular challenge due to asymptomatic cases, high number of contacts, presence of vulnerable people and potential for transmission to family contacts of children and staff. In the CoMMins Study researchers are mapping COVID-19 infection in participating schools with saliva tests, environmental swabs, and sewage analysis.

Pregnant woman undergoing ultrasound and wearing a face mask

Pregnant woman undergoing ultrasound and wearing a face mask

© Castelan Cruz Ricardo / Eyepi… / abaca / picture alliance

Impact on other conditions

the UKOSS study collected information on pregnant women admitted to hospital with COVID-19 in the UK and results have shown that most had good results and transmission to infants was rare. However, the authors also concluded that the high proportion of women from black or minority ethnic groups admitted with infection required urgent investigation.

Studies are also examining immune responses to COVID-19 and / or vaccination in patients with chronic health problems and immunocompromised patients such as those with Cancer and inflammatory bowel disease (IBD) treated with immunosuppressive or biological drugs.

Last year we also posted blogs on heart disease and COVID-19, brain complications of COVID-19 and digital self-management for people living with Cancer during the pandemic.

Take home message

the ISRCTN Registry continues to support global research on COVID-19 by prioritizing the timely registration and notification of studies related to COVID-19. All recorded studies are made available worldwide through the International clinical trials registration platform (ICTRP), and all UK studies appear on Be part of the research.

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