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Test and Treat COVID 65plus+ (COVID65plus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04351516
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:
Patients over equal or older than 65 yearswill be treated with a hydroxychloroquine versus placebo reduced loading dose of 600mg on the first day followed with 400mg/day divided in 2x200mg for 6 more days resulting in a total duration of therapy of 7 days. Measurement of Hydroxychloroquine-levels will be performed on day 7, . A follow-up by video or telephone conference will be performed to observe drug intake and collect adverse events during treatment phase on a daily base on working days and once during the weekend (i.e. 6 out of 7 days). After treatment phase follow-up by telephone calls will be done on day 10, 30, 60 (+/- 2 days).

Condition or disease Intervention/treatment Phase
SARS-CoV 2 COVID-19 Drug: Hydroxychloroquine Other: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Hydroxychloroquine Versus Placebo in Early Ambulatory Diagnosis and Treatment of Elderly COVID19 Patients
Actual Study Start Date : April 21, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: hydroxychloroquine Drug: Hydroxychloroquine
dose of 600mg on the first day followed with 400mg/day divided in 2x200mg for 6 more days

Placebo Comparator: Placebo Other: Placebo
Placebo: Film Coated Tablette




Primary Outcome Measures :
  1. ● Rate of hospitalization or death at day 7 after study inclusion [ Time Frame: 7 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Age ≥ 65 years
  • Mild to moderate symptomatic respiratory tract Infection defined as not requiring hospital admission: SpO2 >94%, respiratory rate <20, mental state alert, no signs of septic shock
  • 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. I.e. must be able to answer to questions concerning symptoms and side effects and must be able to consent to the informed consent.

Exclusion Criteria:

  • Hospitalization at study inclusion
  • Weight <50 kg
  • Acute myocardial infarction
  • Severe heart failure, characterized as NYHA class 3 or 4
  • Use of concomitant medications that prolong the QT/QTc interval.
  • QTc >450ms
  • Bilirubin ≥ 1,5 x UNL, (except for known M. Meulengracht)
  • 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)
  • Bradycardia < 60 beats/min
  • History of Retinopathy or Maculopathy
  • Psoriasis
  • Myasthenia gravis
  • Epilepsy
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351516


Contacts
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Contact: Michael Bitzer, MD +49 7071 2985629 michael.bitzer@med.uni-tuebingen.de
Contact: Manola Zago, PhD zks-pm@med.uni-tuebingen.de

Locations
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Germany
Uniklinikum Tuebingen Recruiting
Tuebingen, Germany
Contact: Michael Bitzer, MD       michael.bitzer@med.uni-tuebingen.de   
Sub-Investigator: Siri Göpel, MD         
Uniklinikum Ulm Recruiting
Ulm, Germany
Contact: Thomas Seufferlein, MD    +49 731 50044501    thomas.seufferlein@uniklinik-ulm.de   
Sub-Investigator: Lukas Perkhofer, MD         
Sponsors and Collaborators
University Hospital Tuebingen
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04351516    
Other Study ID Numbers: COVID65plus
2020-001482-37 ( EudraCT Number )
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents