Status:
TERMINATED
Hydroxychloroquine for the Treatment of Mild COVID-19 Disease
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Robert Bosch Medical Center
Universitätsklinikum Hamburg-Eppendorf
Conditions:
COVID-19
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief 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 approx...
Detailed Description
The study is a double-blinded randomized placebo controlled multicentric trial. The trial is expected to be conducted from April to January 2021. The duration for each individual subject includes 7 da...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04340544
Start Date
April 22 2020
End Date
October 12 2020
Last Update
November 2 2020
Active Locations (1)
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1
Institute for Tropical Medicine
Tübingen, Germany, 72074