COVID-19 Medicines, Vaccines and Clinical Studies
Considering the relevant impact of the COVID-19 pandemic broadly on the society and on the health care system worldwide, it is crucial to expedite the development of effective measures to fight and prevent the spread of this virus, as well as to generate robust and interpretable evidence that would allow prompt definition of effective and safe therapeutics or vaccines against COVID-19.
This priority has been highlighted also by the European Medicines Agency in a press release that you find here.
In response to this emergency, clinical trials and other studies assessing candidate interventions, including experimental treatments or vaccines as well as repurposed medicines, are emerging at an unprecedented rate.
To date, more than 2000 clinical trials, testing vaccines and other potential treatments (drugs, cell-based therapies and immunotherapies) have been registered to different international and national clinical trial registries.
This page intends to provide with an overview of the treatments currently under evaluation or already approved at the European level and of the clinical trials currently launched worldwide for COVID-19, as collected within the COVID-19 clinical trials Registry (more details about the registry here).
COVID-19 treatments: authorisation status in Europe
In response to the global COVID-19 pandemic the European Medicines Agency is committed in expediting the development and approval of safe and effective treatments and vaccines. We offer here below an insight on the treatments' authorisation status in Europe.
Medicines undergoing evaluation
Vaccines undergoing evaluation
A FOCUS ON RARE DISEASES
Due to the COVID-19 pandemic, people living with a rare disease are facing several difficulties in getting the needed treatments including lifesaving care, besides a higher risk of COVID-19 complications.
Ensuring them the access to COVID-19 vaccines, should be widely considered as a priority. Particular attention should be paid to different rare disease patients as they often suffer from comorbidities or take immunosuppressive therapies that might impair the vaccines action and response.
To address rare disease patients concerns and to guide the COVID-19 vaccines administration, some of the scientific societies and associations for rare diseases have already released guiding documents and FAQ sections for patients and healthcare professionals.
Information on the COVID-19 Clinical Trials and Studies
2822 clinical studies on COVID-19 were registered by the 26th April 2021.
We provide here with further detailed information on these trials with reference to the clinical trial phase, the study design and the results when available.
Not yet recruiting
The study has not started recruiting participants
The study is currently recruiting participants or participants are being examined or treated.
The study has ended normally, and participants are no longer being examined or treated
The study has stopped early but may start again
The study has stopped early and will not start again. Participants are no longer being examined or treated
Geographical distribution of the clinical trials
Africa: 109 studies
Asia: 798 studies (415 in China)
Europe: 664 studies
Middle East: 356 studies
North & Central America: 714 studies (587 in the US)
Oceania: 37 studies
South America: 144 studies
Clinical Trial phase*
The study tests subtherapeutic doses (micro doses) on humans. They are planned to expedite the clinical evaluation of new molecular entities, allowing the demonstration of drug-target effects and assessment of pharmacokinetic-pharmacodynamic relationships in humans earlier in clinical development. Usually there is limited published experience with Phase-0 trials. The high number of this kind of trials for COVID-19 can be explained by the necessity to make the drug development process faster in this emergency situation.
This number includes mainly vaccinations and cellular therapies under development for COVID-19. The Phase-I study assesses the safety of the drug. It usually includes a small number of healthy volunteers (20 to 100). The study is designed to determine the effects of the drug on humans including how it is absorbed, metabolised, and excreted. This phase also investigates the side effects that occur as dosage levels are increased.
The study tests the safety, side effects, and best dose of a new treatment. Phase I/II clinical trials also test how well a certain type of disease responds to a new treatment. In the phase II part of the clinical trial, patients usually receive the highest dose of treatment that did not cause harmful side effects in the phase I part of the clinical trial. Combining phases I and II, in COVID-19 clincial trials, may allow research questions to be answered more quickly or with fewer patients.
The study tests the efficacy of the drug and involves up to several hundred patients. This phase is also important to determine the correct dose to be experimented in the next phase. This high number of COVID-19 phase II trials is encouraging since it documents that hundreds of trials have already successfully ended the phase I
The study tests how well a new treatment works for a certain type of disease and compares the new treatment with a standard treatment. Phase II/III clinical trials may also provide more information about the safety and side effects of the new treatment. Combining phases II and III, in COVID-19 clincial trials, may allow research questions to be answered more quickly or with fewer patients.
The study involves several hundreds to several thousands patients. This large-scale testing, which can last several years, provides with more understanding of the efficacy of the drug, the benefits and the range of possible adverse reactions. The Covid-19 Phase III studies will last around 1 year.
After the marketing authorisation, the regulatory agencies keep on monitoring the efficacy and safety of the drug on the general population. Phase IV is based on post-marketing studies and on the spontaneous reports of adverse events from physicians, pharmacists and patients themselves. In the context of COVID-19 pandemic, several medicines already authorised for other conditions are being tested to treat COVID-19 and these trials have been classified as phase IV.
*For the 504 studies not included in the above groups data is not available.