Test and Treat COVID 65plus+ (COVID65plus)
Primary Purpose
SARS-CoV 2, COVID-19
Status
Withdrawn
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Hydroxychloroquine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV 2
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
Sites / Locations
- Uniklinikum Tuebingen
- Uniklinikum Ulm
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
hydroxychloroquine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
● Rate of hospitalization or death at day 7 after study inclusion
Secondary Outcome Measures
Full Information
NCT ID
NCT04351516
First Posted
April 15, 2020
Last Updated
January 12, 2021
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT04351516
Brief Title
Test and Treat COVID 65plus+
Acronym
COVID65plus
Official Title
Randomized Controlled Trial of Hydroxychloroquine Versus Placebo in Early Ambulatory Diagnosis and Treatment of Elderly COVID19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No Patients enrolled
Study Start Date
April 21, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV 2, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hydroxychloroquine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
dose of 600mg on the first day followed with 400mg/day divided in 2x200mg for 6 more days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo: Film Coated Tablette
Primary Outcome Measure Information:
Title
● Rate of hospitalization or death at day 7 after study inclusion
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Uniklinikum Tuebingen
City
Tuebingen
Country
Germany
Facility Name
Uniklinikum Ulm
City
Ulm
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32650818
Citation
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.
Results Reference
derived
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Test and Treat COVID 65plus+
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