Hydroxychloroquine for COVID-19

• Status: Terminated
• Trial end date: 2021-02-26
• Target enrollment: 0
• Participant gender: All

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 is no data available on the efficacy of antiviral agents for the treatment of COVID-19. In vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 replication and anecdotal reports from COVID-19 patients in China and France suggest that chloroquine or hydroxychloroquine is a good candidate for treatment. In the French study a favourable effect was seen when hydroxychloroquine was used together with azithromycin in a small series of COVID-19 patients. However, so far all published evidence is based on non-controlled use of hydroxychloroquine.

We propose to conduct a placebo-controlled trial in COVID-19 patients with mild to moderate disease in Germany to assess virological efficacy, tolerability and safety of hydroxychloroquine in the treatment of COVID-19. The objective of this trial is to identify an effect of hydroxychloroquine on viral clearance in vivo. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post-exposure prophylaxis of COVID-19.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Collaborators: Bernhard Nocht Institute for Tropical Medicine; Robert Bosch Medical Center; Universitätsklinikum Hamburg-Eppendorf
• Treatments: Hydroxychloroquine

Criteria

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 (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.