Paul-Ehrlich-Institut

Coronavirus and COVID-19

Biomedicines

In various studies world-wide, scientists have examined a number of medicines to treat and prevent COVID-19. Some of them have already been used successfully to treat other virus infections and have been studied in clinical trials. All of these medicines must be re-evaluated scientifically for safety and efficacy in COVID-19. A combined use of multiple therapeutics is also conceivable.

Antibodies from persons who have recovered from a COVID-19 (convalescent plasma)

The administration of serum from persons who have recovered from COVID-19 to those infected with the virus, or, alternatively, purified antibodies against SARS-CoV-2 (so-called hyper-immunoglobulins) represents a passive form of immunisation. These antibodies bind and neutralise the virus and thus support the immune system in fighting the infection.

Immunotherapy with monoclonal antibodies

Anti-inflammatory monoclonal antibodies bind to surface molecules on cells and interrupt inter- and intracellular signalling pathways, e.g. via the interleuikin-6 receptor. The aim is to prevent or inhibit an exuberant immune response which is often observed in the course of COVID-19.

Mesenchymal stem cells

These cells are precursors for many different cell types in the human body. Their purpose is to have an anti-inflammatory effect in patients severely affected by COVID-19 following a transplantation, thus protecting lung tissue and regenerating damaged lung tissue. In Germany, they always require a manufacturing authorisation pursuant to the Good Manufacturing Practice (GMP) for the use in humans.

Neutralising monoclonal antibodies

Monoclonal antibodies bind structures on the virus or block receptors on human cells thus preventing the virus from entering the cell, the human immune response from overreacting, or the virus from interacting with the immune system.

The Federal Minister of Health Jens Spahn had announced that from February 2021 certain monoclonal antibodies against the coronavirus SARS-CoV-2 can be used in Germany as soon as they are available in Germany. Currently these are the antibody Bamlanivimab, which was developed by the US pharmaceutical company Eli Lilly, and the other, RegnCoV-2, consisting of the two antibodies Casirivimab/Imdevimab from the Swiss pharmaceutical company Roche and the US company Regeneron.

Because of the new emerging SARS-CoV-2 virus variants, the COVRIIN specialist group at the Robert Koch Institute has specified the possible use of the available monoclonal antibodies. According to this, the use of monoclonal antibodies in monotherapy (only one monoclonal antibody) in immunosuppressed patients may not lead to complete virus elimination and promote the development of so-called escape mutations. Combination therapy with two monoclonal antibodies should therefore be preferred in this group of patients. In the case of immunocompetent patients, on the other hand, monotherapy with Bamlanivimab is possible, provided that it is not the worrying SARS-CoV-2 variants B.1.135 (South African variant) or P1 (Brazilian variant). If the status remains unclear, the local epidemiological situation should be taken into account.

Possible use of monoclonal antibodies depending on the diagnosed SARS-CoV-2 virus variant (as of 29 March 2021) (German only)
Drug therapy for COVID-19 with evaluation by the COVRIIN specialist group at the Robert Koch Institute (as of 23 February 2021) (German only)

FAQ Vaccines and Biomedicines - Monoclonal Antibodies

Antivirals

Antivirals inhibit the activity, structure, and replication of the virus in the human body (e.g. protease inhibitors, RNA-polymerase inhibitors).

Further Information

Monoclonal Antibody Cocktails against COVID-19 in Rolling Review
Paul-Ehrlich-Institut Approves First COVID-19 Therapy Study with Convalescent Plasma
RECOVER – the Paul-Ehrlich-Institut Authorises another COVID-19 Therapy Study with Reconvalescent Plasma
Recommendation of the Paul-Ehrlich-Institut for the Collection and Manufacture of COVID-19 Convalescent Plasma
Therapy against COVID-19 Symptoms under Development - Clinical Trials for Sarilumab authorised
Call for Blood Donations made by the PEI, Robert Koch Institute (RKI), and the Federal Centre for Health Education (BZgA) – Please observe the Appointments offered for Blood Donations!
RKI, Paul-Ehrlich-Institut and BZgA Call for Blood and Plasma Donations - Please Donate Even During Lockdown!

Content

  1. Role of the Paul-Ehrlich-Institut
  2. COVID-19 Vaccines
  3. FAQ Coronavirus
  4. Biomedicines
  5. Safety of COVID-19 Vaccines
  6. Research Work
  7. SARS-CoV-2 Test Systems