Hydroxychloroquine for the Treatment of Mild COVID-19 Disease

• Status: Terminated
• Trial end date: 2020-10-12
• Target enrollment: 0
• Participant gender: All

Summary

The current outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (>57.000) 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 [1] replication and anecdotal reports from Chinese COVID-19 patients [2, 3] suggest that chloroquine is a good candidate for treatment. No data have been published and reported evidence is based on non-controlled use of hydroxychloroquine.

The aim of this placebo-controlled trial is to assess the effect of hydroxychloroquine on duration of symptoms in mild COVID-19 patients and time of virus shedding as an important tool to reduce the risk of further community transmissions. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post- and preexposure prophylaxis of COVID-19 and as a tool for reduction of community transmission.

• Phase: Phase 2
• 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:

• Must be ≥18 years at the time of signing the informed consent

• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures

• Able to adhere to the study visit schedule and other protocol requirements

• Mild COVID-19 with outpatient management as decided by the treating physician

• Early warning score for 2019-nCoV infected patients ≤ 5

• Females of childbearing potential (FCBP1) must agree

• to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe

• to abstain from breastfeeding during study participation and 28 days after study drug discontinuation

• All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment

• All subjects must agree not to share medication

Exclusion Criteria:

• Requirement for oxygen administration

• Shortness of breath in resting position

• Creatinin > 2.0 mg/dl

• Women during pregnancy and lactation

• Participation in other clinical trials or observation period of competing trials

• Active or clinically significant cardiac disease including congestive heart failure (New York Heart Association Class III or higher)

• History or current evidence of clinically significant cardiac arrhythmia except atrial fibrillation or paroxysmal supraventricular tachycardia

• Use of concomitant medications that prolong the QT/QTc interval

• Physician decision that involvement in the study is not in the patient´s best interest