Acute coronavirus disease 2019 MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Quensyl
Pharmaceutical Form: Capsule
INN or Proposed INN: Hyroxychloroquine sulfate
CAS Number: 747-36-4
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Concentration unit: mg milligram
Sponsors
Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Inclusion 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 = 4 • Females of childbearing potential (FCBP) must agree: o to practice continuous effective contraception 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 (a method which results in a failure rate less than 1% per year) o 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2360 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 340
Exclusion criteria
Exclusion criteria: • Requirement for supplemental oxygen • Shortness of breath in resting position • Early warning score of 3 in one of the categories: o Respiratory rate (=8 or =25 breaths/min) o Systolic blood pressure (=90 mmHg or =220 mmHg) o Heart rate (=40 or = 130 beats/min) • Known or suspected renal insufficiency • Known glucose-6-phosphate-dehydrogenase deficiency (favism) • Known Myasthenia gravis • Ongoing disorders of the hemopoietic system • Known hypersensitivity against 4-amino-quinolines • Women during pregnancy and lactation • Current participation in other clinical interventional trials • Elevated Tisdale score for QTc prolongation (score between 7-21) • History or current evidence of clinically significant cardiac arrhythmia except atrial fibrillation or paroxysmal supraventricular tachycardia • Active or clinically significant cardiac disease including congestive heart failure (New York Heart Association Class III or higher) • Epilepsy • Physician decision that involvement in the study is not in the patient´s best interest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: 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 ;Primary end point(s): The primary endpoint will be the difference in duration from the initiation of treatment until resolution of the clinical signs and symptoms assessed by daily self-assessment in hydroxychloroquine- versus placebo-treated patients.;Timepoint(s) of evaluation of this end point: One interim analysis for evaluating the primary efficacy endpoint is planned for this study. The interim analysis will be done when 40% of events have accrued. A one-sided Hwang-Shih-DeCani spending function with gamma = -4 (alpha-spending) was considered in the sample size calculation to account for multiplicity repeated tests. In case the interim analysis shows a HR > 1.21 (nominal p < 0.0018), efficacy is shown and the trial may be stopped. Final analysis upon completion of the trial and final database lock | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference between hydroxychloroquine- and placebo-treated patients on an ordinal outcome scale until Day 28 (death, requiring intensive care, requiring hospitalization, outpatient but ill, healthy) All-cause mortality within 28 days ;Timepoint(s) of evaluation of this end point: After interim and final database lock | — |
Countries
Germany
Contacts
Public ContactDiane Egger-Adam
Univeristätsklinikum Tübingen
Outcome results
None listed