Randomized controlled trial of hydroxychloroquine versus placebo in early ambulatory diagnosis and treatment of elderly COVID-19 Patients

Phase 1

• Conditions: Coronavirus disease; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001482-37-DE
• Lead Sponsor: niversity Hopsital Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

•Written informed consent
•Age = 65 years
•Mild to moderate symptomatic respiratory tract Infection
•Proven SARS-Cov2 infection by throat swab (PCR)
•Onset of symptoms within the last 3 days before randomization
•Must be able to adhere to the study visit schedule and other protocol requirements in the investigator’s opinion.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion Criteria

•Hospitalization at study inclusion
•Weight <50 kg
•Acute myocardial infarction
•Use of concomitant medications that prolong the QT/QTc interval.
•QTc >450ms
•Bilirubin = 1,5 x UNL,
•AST/ALT = 3 x ULN
•Albumine = 2.8 g/dl
•Hemoglobin = 9 g/dl
•Leucocytes = 2000/µl
•Neutrophiles = 1000/µl
•Thrombocytes = 100.000/µl
•Troponin elevation
•BNP > 500 pg/ml
•Creatine kinase > 5 x ULN
•Creatinine >1,5 mg/dl
•Uncorrected hypopotassemia or hypomagnesemia
•History of hypoglycemic events
•History of or present cardial arrhythmia (except atrial fibrillation or paroxysmal supraventricular tachycardia)
•History of Retinopathy or Maculopathy
•Psoriasis
•Myasthenia gravis
•Immunodeficiency syndromes or need for highly immunosuppressive medication
•Pre-existing medication with hydroxychloroquine
•Known G6PD deficiency.
•Participation in another interventional study
•Known hypersensibility to hydroxychloroquine and its derivates
•Subject (male or female) is not willing to use highly effective methods of contraception according to the Clinical trial fertility group” recommendations (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) during treatment until day 30 from first dose (adequate: combined hormonal contraceptionassociated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormonereleasing-system, bilateral tubal occlusion, vasectomized partner1, sexual abstinence2).
1 Vasectomized partner is a highly effective birth control method provided that partner is the
sole sexual partner of the WOCBP trial participant and that the vasectomized partner has
received medical assessment of the surgical success2 In the context of this guidance sexual
abstinence is considered a highly effective method only if defined as refraining from
heterosexual intercourse during the entire period of risk associated with the study treatments.
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Rate of hospitalization or death at day 7 after study<br>inclusion;Secondary Objective: Duration of hospitalization<br>? Time to hospitalization<br>? Reason for hospitalization<br>? severity of disease at hospitalization<br>? All-cause mortality within 30/60 days<br>? COVID19 related mortality within 30/60 days<br>? Proportion requiring invasive ventilation<br>? Proportion admitted to ICU<br>? Rate of viral clearance defined as SARS-CoV2 specific<br>RNA copy number <100 in throat swabs on day 7<br>? Optional rate of viral clearance on d 14, 21;Primary end point(s): Hospitalization or death<br>;Timepoint(s) of evaluation of this end point: 7 days after first dosis

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Duration of hospitalization<br>? Time to hospitalization<br>? Reason for hospitalization<br>? severity of disease at hospitalization<br>? All-cause mortality within 30/60 days<br>? COVID19 related mortality within 30/60 days<br>? Proportion requiring invasive ventilation<br>? Proportion admitted to ICU<br>? Rate of viral clearance defined as SARS-CoV2 specific<br>RNA copy number <100 in throat swabs on day 7<br>? Optional rate of viral clearance on d 14, 21;Timepoint(s) of evaluation of this end point: 60 days after first dosis