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Hydroxychloroquine for the Treatment of Mild COVID-19 Disease (COMIHY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04340544
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : May 11, 2020
Sponsor:
Collaborators:
Robert Bosch Medical Center
Universitätsklinikum Hamburg-Eppendorf
Bernhard Nocht Institute for Tropical Medicine
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:

The current outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (>57.000) in Germany. There is no data available on the efficacy of antiviral agents for the treatment of COVID-19. In-vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 [1] replication and anecdotal reports from Chinese COVID-19 patients [2, 3] suggest that chloroquine is a good candidate for treatment. No data have been published and reported evidence is based on non-controlled use of hydroxychloroquine.

The aim of this placebo-controlled trial is to assess the effect of hydroxychloroquine on duration of symptoms in mild COVID-19 patients and time of virus shedding as an important tool to reduce the risk of further community transmissions. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post- and preexposure prophylaxis of COVID-19 and as a tool for reduction of community transmission.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine for the Treatment of Mild COVID-19 Disease
Actual Study Start Date : April 22, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxychloroquine
Hydroxychloroquine 600mg daily for 7 days
Drug: Hydroxychloroquine
Hydroxychloroquine Sulfate is an anti-malarial and anti-rheumatic drug and seems to be a potential candidate for the treatment of COVID-19 since it is able to block virus infection by increasing the endosomal pH, required for virus/cell fusion, it affects the activation of p38 mitogen-activated protein kinase (MAPK), involved in the replication of HCoV-229E and can interfere with the terminal glycosylation of ACE2, thus inhibiting SARS-CoV-2 infection.

Placebo Comparator: Placebo
Equivalent number of placebo capsules
Drug: Placebo
Placebo capsules




Primary Outcome Measures :
  1. Difference in time to resolution of clinical signs and symptoms of mild COVID-19 treated with hydroxychloroquine or placebo as assessed by daily self-assessment [ Time Frame: 28±2 days ]

Secondary Outcome Measures :
  1. Difference between hydroxychloroquine- and placebotreated patients on an ordinal outcome scale until Day 28 (death, admission to intensive care, hospitalization, continuing disease, recovered) [ Time Frame: 28±2 days ]
  2. All-cause mortality within 28 days [ Time Frame: 28±2 days ]

Other Outcome Measures:
  1. Proportion of patients with negative COVID-19 PCR test at day 14 in per protocol population as per throat swab [ Time Frame: 28±2 days ]
  2. Change in COVID-19 virus load from baseline to day 14 [ Time Frame: 28±2 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be ≥18 years at the time of signing the informed consent
  • Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
  • Able to adhere to the study visit schedule and other protocol requirements
  • Mild COVID-19 with outpatient management as decided by the treating physician
  • Early warning score for 2019-nCoV infected patients ≤ 5
  • Females of childbearing potential (FCBP1) must agree
  • to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe
  • to abstain from breastfeeding during study participation and 28 days after study drug discontinuation
  • All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment
  • All subjects must agree not to share medication

Exclusion Criteria:

  • Requirement for oxygen administration
  • Shortness of breath in resting position
  • Creatinin > 2.0 mg/dl
  • Women during pregnancy and lactation
  • Participation in other clinical trials or observation period of competing trials
  • Active or clinically significant cardiac disease including congestive heart failure (New York Heart Association Class III or higher)
  • History or current evidence of clinically significant cardiac arrhythmia except atrial fibrillation or paroxysmal supraventricular tachycardia
  • Use of concomitant medications that prolong the QT/QTc interval
  • Physician decision that involvement in the study is not in the patient´s best interest

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340544


Contacts
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Contact: Diane Egger-Adam, Dr. +4970712982191 diane.egger-adam@uni-tuebingen.de
Contact: Peter Kremsner, Prof. +4970712987179 peter.kremsner@uni-tuebingen.de

Locations
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Germany
Institute for Tropical Medicine Recruiting
Tübingen, Germany, 72074
Contact: Diane Egger-Adam, Dr.    +4970712982191    diane.egger-adam@uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Robert Bosch Medical Center
Universitätsklinikum Hamburg-Eppendorf
Bernhard Nocht Institute for Tropical Medicine
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04340544    
Other Study ID Numbers: COMIHY
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents