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Clinical Trials/EUCTR2020-001482-37-DE
EUCTR2020-001482-37-DE
Active, not recruiting
Phase 1

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

niversity Hopsital Tuebingen0 sites350 target enrollmentApril 20, 2020
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ConditionsCoronavirus diseaseTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsHydroxychloroquin-ratiopharm 200 mg Filmtabletten

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Coronavirus disease
Sponsor
niversity Hopsital Tuebingen
Enrollment
350
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 20, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity Hopsital Tuebingen

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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