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Feb 16 • 6 tweets • 3 min read
We finally got some updates on the upcoming phase II clinical trial with #BC007 for #LongCOVID from @BerlinCures over the last couple of weeks.

A short thread.
BerlinCures has now officially submitted the clinical trial application to the BfArM (medical regulatory body in Germany).

According to an article about #BC007 two weeks ago the necessary approvals could be granted very soon.
The study will be conducted at different clinical centers across Europe.

One clinical center seems to be in Vienna in Austria, another in Switzerland. The others will hopefully be announced soon.
The start of the clinical trial seems to be scheduled for April/May 2023.
The number of participants is now expected to be around 100.
Unfortunately we are still waiting for an update on the reCOVer-trial at Erlangen with #BC007 for #LongCOVID which still hasn’t started because the drug hasn’t been delivered.

We also didn’t get any new information on the planned #MECFS study at Erlangen.
Most of the new information comes from this short podcast and these articles.

zeit.de/politik/2023-0…

zeit.de/gesundheit/202…

kurier.at/wissen/gesundh…

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More from @Raoul__Lucas

Raoul Schendel Profile picture
Oct 18, 2022
This week two new articles about #BC007 were published where managers from @BerlinCures talk about the company’s planned steps and studies for #LongCOVID for this year and 2023.

In this thread is a short summary.
According to one new interview BerlinCures has now collected the necessary funds for a Phase II study with #BC007 for #LongCOVID.
The number of participants will be significantly higher than 100.
BerlinCures wants to submit the Clinical Trial application in the upcoming weeks.

Results from this study are expected in August-December 2023.
Read 7 tweets
Raoul Schendel Profile picture
Oct 16, 2022
In der FAZ gibt es einen neuen Artikel über #BC007 und @BerlinCures.
Darin wird unter anderem über die Studien für #LongCOVID und die weiteren geplanten Schritte des Unternehmens gesprochen.

In diesem Thread ist eine kurze Zusammenfassung.

faz.net/aktuell/wirtsc…
Laut dem Artikel hat BerlinCures mittlerweile die finanziellen Mittel eingetrieben, um eine Phase-II-Studie mit BC007 für LongCOVID zu starten.

An dieser Studie sollen deutlich über 100 Patienten teilnehmen.
Mit Ergebnissen rechnet das Unternehmen im August-Dezember 2023.

Sollte das Medikament auch eine Phase-III-Studie erfolgreich bestehen, könnte es „frühestens Ende nächsten Jahres, realistisch in 2024“ verfügbar sein.
Read 4 tweets
Raoul Schendel Profile picture
Sep 30, 2022
In einem neuen Artikel des Tagblatt über #BC007 gibt es einige neue Informationen über die aktuelle Situation und die geplanten #LongCOVID und #MECFS Studien.

In diesem Thread ist eine kurze Zusammenfassung.

tagblatt.ch/leben/langzeit…
Laut Herrn Prof. Mardin vom Universitätsklinikum Erlangen sind bei einem der vier mit #BC007 behandelten Patienten 15 Monate nach der Infusion die LongCOVID Beschwerden nach einer Omikron-Infektion wieder aufgetreten.
BerlinCures scheint die Studien in Erlangen für #LongCOVID und #MECFS nicht zu unterstützen, da das Unternehmen befürchtet, dass zu schlechte Ergebnisse dieser Studien Investoren abschrecken könnten.
Read 9 tweets
Raoul Schendel Profile picture
Aug 25, 2022
We got some more updates on the upcoming trials with #BC007 for #LongCOVID and #MECFS over the last couple of weeks.

In this thread is a short overview of the three planned studies and their current status.
The reCOVer-project at the UK-Erlangen for #LongCOVID, which will be conducted by @Dr_Hohberger and her team, is scheduled to start in the upcoming months.
In recent interviews it was said that the team hopes to be able to start in September/October.
Currently they are still waiting for the delivery of #BC007 from @BerlinCures.

Thirty LongCOVID patients will take part in this trial, ten of them will get a placebo.
Read 7 tweets
Raoul Schendel Profile picture
Jul 20, 2022
In the last couple of weeks we got some more information about the clinical treatment trials for #LongCOVID and #MECFS here in Germany which are funded by the Federal Ministry of Education and Research with 10 million €.

Here’s what we know about them so far.
The trials will be managed by the @ChariteBerlin and @C_Scheibenbogen.

Prof. Scheibenbogen thinks that the 10 million € are sufficient to conduct 10 clinical studies.
These are the Clinical Centers where the studies will take place.
Read 9 tweets

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