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Mar 17 • 4 tweets • 2 min read
BerlinCures has now received the necessary approvals for their phase II clinical trial with #BC007 for #LongCOVID in Germany.

In this thread is a short summary of the other new information in this article.

tagblatt.ch/leben/long-cov…
The study is planned to start in the second quarter of 2023.

Besides Germany the study will also take place in Switzerland, Austria, Finland and Spain.
In these countries @BerlinCures is still waiting for the necessary approvals.
Altogether the number of participants will be over 100.

One third will be getting a placebo, 76 the drug, in two different dosages.
Unfortunately only people whose initial infection has not been longer ago than 12 months are allowed to take part in the trial.

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More from @Raoul__Lucas

Raoul Schendel Profile picture
Mar 17
BerlinCures hat für die Phase II-Studie mit #BC007 für #LongCOVID laut diesem Artikel in DE die nötigen Genehmigungen des BfArM und der Ethikkomissionen erhalten.

In diesem Thread sind die weiteren neuen Informationen des Artikels kurz zusammengefasst.

tagblatt.ch/leben/long-cov…
Die Studie soll im zweiten Quartal 2023 starten.

Die Genehmigungen in den übrigen Ländern, wo die Studie stattfinden wird (der Schweiz, Spanien, Österreich und Finnland), stehen noch aus.
Insgesamt werden über 100 Patienten an der Studie teilnehmen.

Ein Drittel wird ein Placebo erhalten, 76 Personen werden das Medikament erhalten, aufgeteilt in zwei unterschiedliche Dosierungen.
Read 5 tweets
Raoul Schendel Profile picture
Feb 16
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.
Read 6 tweets
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

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