Test and Treat COVID 65plus+ (COVID65plus)

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

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).

Study Overview

• Status: Withdrawn
• Conditions: COVID-19; SARS-CoV 2
• Intervention / Treatment: Drug: Hydroxychloroquine; Other: Placebo

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany
    • Uniklinikum Tuebingen
  • Ulm, Germany
    • Uniklinikum Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine
• Other Study ID Numbers: COVID65plus; 2020-001482-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No