Test and Treat COVID 65plus+

Study Overview
=================
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).

Official Title
-----------------
Randomized Controlled Trial of Hydroxychloroquine Versus Placebo in Early Ambulatory Diagnosis and Treatment of Elderly COVID19 Patients

Conditions
-----------------
SARS-CoV 2, COVID-19

Intervention / Treatment
-----------------
* Drug: Hydroxychloroquine
* Other: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydroxychloroquine<br> | Drug: Hydroxychloroquine<br>* dose of 600mg on the first day followed with 400mg/day divided in 2x200mg for 6 more days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo: Film Coated Tablette<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ● Rate of hospitalization or death at day 7 after study inclusion |  | 7 days |