COMIHY

Purpose / Objectives

Primary Outcome

Difference in time to resolution of clinical signs and symptoms of mild COVID-19 treated with hydroxychloroquine or placebo as assessed by daily self-assessment

Secondary Outcomes

• Difference between hydroxychloroquine- and placebo treated patients on an ordinal outcome scale until Day 28 (death, admission to intensive care, hospitalization, continuing disease, recovered
• All-cause mortality within 28 days

Other Pre-specified Outcome Measures:

• Proportion of patients with negative COVID-19 PCR test at day 14 in per protocol population as per throat swab
• Change in COVID-19 virus load from baseline to day 14

Diagnosis

• COVID-19 infection

Target population

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

Study design

• Phase II
• Multicenter
• Two-arm
• Double-blind
• Randomized
• Placebo-controlled

Intervention

Experimental Arm Medication: Hydroxychloroquine (600mg daily for 7 days)

Placebo Comparator: equivalent number of placebo capsules

Documents (password protected)

Go to download area (no documents yet)

Responsibilities in overall study

Sponsor

Universitätsklinikum Tübingen

• Tel. +49 (0)7071 29-0

(National) Coordinating Investigator

Prof. Dr. med. Peter Kremsner

Project management

Institut für Tropenmedizin Tübingen

• Tel. +497071 2982191
• Fax +497071 294684

Monitoring

Zentrum für Klinische Studien (ZKS) Tübingen

Data management

Institut für Tropenmedizin Tübingen

• Tel. +497071 2982191
• Fax +497071 294684

Database development

Institut für Tropenmedizin Tübingen

• Tel. +497071 2982191
• Fax +497071 294684

SAE management

Zentrum für Klinische Studien (ZKS) Tübingen

Statistics

Institut für Tropenmedizin Tübingen

• Tel. +497071 2982191
• Fax +497071 294684