FAQ for participants

RBDCOV is a European project that will perform two clinical trials currently based on previous AEMPS (Spanish Agency of Medicines and Medical Products) and EMA (European Medicines Agency’s) advisory meetings.

General information about clinical trials

Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care.

Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.

The patient has a right to withdraw from the study at any moment they decide to, as participation is completely voluntary.

A trial can have two or more groups of participants, in order to compare the results produced by each group. After we recruit the number of participants we aimed for, and before the start of the study, we assigned them randomly to one of the trial’s groups. This is to ensure that the results between the groups are comparable and are not biased.

Inclusion criteria are a set of predefined characteristics used to identify individuals who will be included in a research study.

Exclusion criteria are a set of predefined definitions that is used to identify individuals who will not be included or who will have to withdraw from a research study after being included.

Informed consent is the act of agreeing to allow something to happen, or to do something, with a full understanding of all the relevant facts, including risks, and available alternatives

If you confirm your participation in a clinical trial, data can be only processed for the purpose of that trial. The EU GDPR requires that personal data is collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes.

Participants should be aware that all predictable measures will be kept to ensure confidentiality of study participant.

An individual has the right to withdraw their consent at any time during the conduct of the clinical trial, without necessarily having to provide any explanation for this. This information should be given to people before they consent to participate in a clinical trial.

What it means to take part in RBDCOV clinical trials?

The study is divided into two different clinical trials. One will be conducted in children and adolescents, and the other in immunocompromised people. Furthermore, the study has been designed so that all data be sex and gender-disaggregated and consider critical social factors intersecting with sex/gender, such as age, social origin, ethnicity/migration, and disability.

The clinical trials will be conducted in two countries: Spain and Turkey. In the case of Turkey, they will be conducted solely at Metpharm’s facilities, while in Spain, they will be divided between several centres: Vall d’Hebron Research Institute (VHIR) (Barcelona), Hospital Clínic de Barcelona (Barcelona), Institut d’Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI) (Girona), Fight AIDS and Infectious Diseases Foundation (FLS) (Badalona).

The first clinical trial, the one focused on immunocompromised people, will start in May. The second one, for paediatric population, probably starts in June or July.

In both clinical trials ( paediatric and adolescent and immunocompromised), an average of 4 hospital visits will be made. In addition, about 2 phone calls will be made to check on the participants’ condition and they will be given a diary to record any reactions they may feel during the first 7 days.