Status:
TERMINATED
Hydroxychloroquine for COVID-19
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Robert Bosch Medical Center
Universitätsklinikum Hamburg-Eppendorf
Conditions:
COVID-19, Hydroxychloroquine Sulfate
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
The current outbreak of COVID-19 caused by SARS-CoV-2 is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (\>9500) in Germany. There ...
Detailed Description
The study is a randomized placebo controlled multicentric Phase III trial. The duration of the trial for each subject is expected to be 6 months. The duration for each individual subject includes 7 da...
Eligibility Criteria
Inclusion
- Written informed consent
- Age above 18 years
- Women of childbearing age only: Must agree to practice continuous effective contraception for the duration of the study (a method which results in a failure rate less than 1% per year)
- Disease severe enough to require hospitalization
- QTc interval lower than 450 msec
Exclusion
- Respiratory rate \>24/min
- Pregnancy (tested with a pregnancy test) or lactation
- Weight \<50 kg
- Hemodynamic/rhythm instability
- Acute myocardial infarction Type 1
- Use of concomitant medications that prolong the QT/QTc interval.
- Any regular concomitant medication which is contraindicated in the use together with HCQ
- Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines
- Pre-existing retinopathy or maculopathy
- Known Glucose-6-phosphate dehydrogenase deficiency (haemolytic anaemia, Favism)
- Haematopoietic systems diseases
- Myasthenia gravis
- Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
- Additionally, clinical evaluation and laboratory values inform eligibility of the patient based on the judgement of the study team. These may include: total bilirubin, transaminase level, albumin concentration, haematological parameters, troponin and BNP levels, creatinine, creatinine kinase levels.
Key Trial Info
Start Date :
March 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04342221
Start Date
March 29 2020
End Date
February 26 2021
Last Update
May 3 2021
Active Locations (8)
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1
Zollernalb Klinikum Balingen
Balingen, Germany, 72336
2
Klinikum Darmstadt
Darmstadt, Germany, 64283
3
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20359
4
Johannes Wesling Klinikum Minden
Minden, Germany, 32429