NCT04351516

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

April 21, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

January 15, 2021

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

April 15, 2020

Last Update Submit

January 12, 2021

Conditions

SARS-CoV 2COVID-19

Outcome Measures

Primary Outcomes (1)

  • ● Rate of hospitalization or death at day 7 after study inclusion

    7 days

Study Arms (2)

hydroxychloroquine

EXPERIMENTAL
Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

HydroxychloroquineDRUG

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

hydroxychloroquine
PlaceboOTHER

Placebo: Film Coated Tablette

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Uniklinikum Tuebingen

Tübingen, Germany

Location

Uniklinikum Ulm

Ulm, Germany

Location

Related Publications (1)

  • 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.

    PMID: 32650818DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 17, 2020

Study Start

April 21, 2020

Primary Completion

December 31, 2020

Study Completion

May 1, 2021

Last Updated

January 15, 2021

Record last verified: 2020-04

Locations

DE(2)