Test and Treat COVID 65plus+ (COVID65plus)

University Hospital Tuebingen

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: COVID-19; SARS-CoV 2

Treatments: Other: Placebo; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04351516

COVID65plus

2020-001482-37 (EudraCT Number)

Details and patient eligibility

About

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).

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

hydroxychloroquine

Experimental group

Treatment:

Drug: Hydroxychloroquine

Placebo

Placebo Comparator group

Treatment:

Other: Placebo