Clinical trial NCT04351516: Test and Treat COVID 65plus+
Official title: Randomized Controlled Trial of Hydroxychloroquine Versus Placebo in Early Ambulatory Diagnosis and Treatment of Elderly COVID19 Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: SARS-CoV 2
COVID-19
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: ● Rate of hospitalization or death at day 7 after study inclusion
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Uniklinikum Tuebingen
city: Ulm
country: Germany
facility: Uniklinikum Ulm
Study officials:
References:
citation: Gopel S, Bethge W, Martus P, Kreth F, Iftner T, Joos S, Dobele S, Mordmuller B, Kremsner P, Ettrich T, Seufferlein T, Bitzer M, Malek N. Test and treat COVID 65 plus - Hydroxychloroquine versus placebo in early ambulatory diagnosis and treatment of older patients with COVID19: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jul 10;21(1):635. doi: 10.1186/s13063-020-04556-z.