Covid-19

COVID-19 Studies and Trials in the world

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 1000 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 clinical trials currently launched worldwide for COVID-19, as collected within the COVID-19 clinical trials Registry (more details about the registry here).

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.

Information on the COVID-19 Clinical Trials and Studies

1476 clinical studies on COVID-19 were registered by the 11th June 2020.

Here following useful information about some clinical trials features.

Overview on the clinical trials status

For 8 out of the 51 concluded studies, results have been published (click here to consult them).

Not yet recruiting

Ongoing

Concluded

Suspended

Status not available

Geographical distribution of the clinical trials

Africa: 46 studies
Asia: 445 studies (358 in China)
Europe: 404 studies
Middle East: 208 studies
North & Central America: 317 studies (261 in the US)
Oceania: 17 studies
South America: 39 studies

Study design

Randomized Controlled trials: 1181 studies
Non-randomized controlled trials: 103 studies
Not controlled trials: 182 studies
Compassionate use: 10 studies (more information here)

Clinical Trial phase

Phase 0

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. 

Phase I

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. 

Phase I/II

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.

Phase II

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

Phase II/III

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.

Phase III

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.

Phase IV

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 261 studies not included in the above groups data is not available.

Last update on the 11th June 2020. You can consult all the studies reported in this page and further useful information in the  COVID-19 clinical trials registry.

If you wish to have further analyses focused on specific topics, do not hesitate to contact us.

Legal disclaimer for the COVID-19 page.

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