Test and Treat COVID 65plus+

COVID-19 Clinical Trial

— COVID65plus  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04351516
• Other study ID #: COVID65plus
• Secondary ID: 2020-001482-37
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: April 21, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: April 2020
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV 2

Intervention

Drug:
• Hydroxychloroquine
dose of 600mg on the first day followed with 400mg/day divided in 2x200mg for 6 more days

Other:
• Placebo
Placebo: Film Coated Tablette

Locations

Country	Name	City	State
Germany	Uniklinikum Tuebingen	Tuebingen
Germany	Uniklinikum Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	? Rate of hospitalization or death at day 7 after study inclusion		7 days