Test and Treat COVID 65plus+ (COVID65plus)

• ClinicalTrials.gov Identifier: NCT04351516
• Recruitment Status: Withdrawn
• First Posted: April 17, 2020
• Last Update Posted: January 15, 2021
• Sponsor: University Hospital Tuebingen
• Information provided by (Responsible Party): University Hospital Tuebingen

Study Description

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).

Condition or disease	Intervention/treatment	Phase
SARS-CoV 2; COVID-19	Drug: Hydroxychloroquine; Other: Placebo	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Hydroxychloroquine Versus Placebo in Early Ambulatory Diagnosis and Treatment of Elderly COVID19 Patients
• Actual Study Start Date: April 21, 2020
• Estimated Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: May 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. ● Rate of hospitalization or death at day 7 after study inclusion [ Time Frame: 7 days ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

Germany

Uniklinikum Tuebingen

Tuebingen, Germany

Uniklinikum Ulm

Ulm, Germany

Sponsors and Collaborators

University Hospital Tuebingen

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT04351516
• Other Study ID Numbers: COVID65plus; 2020-001482-37 ( EudraCT Number )
• First Posted: April 17, 2020
• Last Update Posted: January 15, 2021
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Hydroxychloroquine; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents