Status:
WITHDRAWN
Test and Treat COVID 65plus+
Lead Sponsor:
University Hospital Tuebingen
Conditions:
SARS-CoV 2
COVID-19
Eligibility:
All Genders
65+ years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04351516
Start Date
April 21 2020
End Date
May 1 2021
Last Update
January 15 2021
Active Locations (2)
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1
Uniklinikum Tuebingen
Tübingen, Germany
2
Uniklinikum Ulm
Ulm, Germany