The SARS-CoV2 virus causes mild respiratory infection in most people who become ill, but people in vulnerable groups can be seriously affected, with respiratory failure and high mortality. There is no known specific treatment, but studies of antiviral drugs are in full swing. A vaccine for use in Norway is assumed to be 12-18 months ahead.
Because the COVID-19 disease may have such a severe course, it has also been tried whether passive immunization has an effect. Convalescence plasma is now being tested in a number of countries, including the United States, where more than 1,500 study places have been registered in an observational study led by the Mayo Clinic.
The project NORPLASMA COVID-19 part 1 includes the production of convalescence plasma from voluntary blood donors in order to treat COVID-19 patients. It is desirable to evaluate the efficacy and safety of convalescent plasma in randomized trials. Therefore, two research studies to map the effect and safety of treatment with convalescent placenta are being planned and will be presented to REK in the near future (NORPLASMA CARE and NORPLASMA FEVER).
However, there will be situations where the attending physician wishes to give convalescence plasma to patients on clinical indication. In this prospective monitoring study (NORPLASMA MONITOR) we will offer patients who cannot be included in the randomized studies treatment with COVID-19 convalescence plasma. Patients must consent to the treatment, and they must consent for us to obtain information about them for monitoring the safety and efficacy of the treatment.
Before, during and after transfusion, clinical information and test results related to COVID-19 are obtained and recorded. By gathering information from a large number of patients, one will gain knowledge about safety and efficacy that can supplement the results of the other studies so that we learn as much as possible about this new disease.
Processed data from Norway will be included in the EU Commission’s database where data from all EU countries will be collected to conclude on the effect and safety of this treatment in even larger materials.