As an infrastructure at the German Center for Infection Research (DZIF), the Clinical Trial Unit tracks DZIF's study activities in the “Healex Site Management System (SMS)”. Studies are sorted by indication and are continuously updated.

The study register has recently been expanded to include the category “COVID-19”. For the first time, not only DZIF study activities are presented here: In order to provide a comprehensive overview in the current pandemic situation of planned and already active COVID-19 studies in Germany, the Clinical Trial Unit is cooperating with researchers from various German Centers for Health Research and other networks.

For researchers: If your study is not yet included in our portal, please contact the project management of the Clinical Trial Unit (angela.steinbach@uk-koeln.de or vassiliki.dimitriou@uk-koeln.de).

COVID-19 Hydroxychloroquine for COVID-19

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
COV-HCQ2020-001224-33

Randomized controlled trial of hydroxychloroquine versus placebo for the treatment of adult patients with acute coronavirus disease 2019 – COVID-19

Status: Active

Purpose / Objectives

Primary Outcome

Viral clearance defined as time to sustained SARS-CoV-2-specific RNA copy number ≤100, measured by real time reverse-transcription polymerase chain reaction in throat swabs

Secondary Outcomes

  • In-hospital mortality within 60 days
  • All-cause mortality within 60 days
  • Proportion requiring non-invasive ventilation
  • Proportion requiring invasive ventilation
  • Proportion admitted to ICU
  • Duration of hospitalization
  • Reduction in viral RNA load in upper respiratory tract specimen as assessed by area under viral load curve
  • Reduction in viral RNA load in upper respiratory tract specimen defined as decline of RNA load by 2 log-levels or to below detection level

Exploratory objectives: effect of infection on cardiac function, mucosal, humoral and cellular immune response including single cell phenotype and RNA expression, effect on anti-viral defense, assessment of chronic symptoms and quality of life

Diagnosis

Patient attributes

Inclusion criteria

  • 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 criteria

  • Respiratory rate >24/min
  • Pregnancy 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

Trial design

  • Phase III
  • Single center
  • Randomized
  • Two-arm
  • Double-blind
  • Placebo-controlled

Documents (password protected)

Responsibilities in overall trial

DZIF-CTU Tübingen

National Coordinating Investigator

Prof. Dr. med. Peter Kremsner

Project management

DZIF-CTU Tübingen

Data management

DZIF-CTU Tübingen

Statistics

DZIF-CTU Tübingen