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Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial) (HYDRA)

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ClinicalTrials.gov Identifier: NCT04315896
Recruitment Status : Not yet recruiting
First Posted : March 20, 2020
Last Update Posted : March 20, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
National Institute of Respiratory Diseases, Mexico

Brief Summary:
Double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.

Condition or disease Intervention/treatment Phase
COVID-19 Severe Acute Respiratory Syndrome Drug: Hydroxychloroquine Drug: Placebo oral tablet Phase 3

Detailed Description:
Since hydroxychloroquine is a low cost and safe anti-malaria drug that has proven effects against COVID-19 in vitro. The investigators aim to study the security and efficacy of this drug in trough a double blinded randomized clinical trial. Recruited patients with severe respiratory disease from COVID-19 will be randomized to an intervention group (400mg per day dose of hydroxychloroquine) and placebo. The investigators' main outcome will be all cause hospital mortality. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease. Results will be compared in an intention to treat analysis. All clinical, analysis and data team members will be blinded to treatment assignment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded, randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Clinical practitioners and data analysts will remain blinded all through the study. Blinding will end in case the attending physician considers the patient should abandon the study or some of the exclusion/elimination criteria apply.
Primary Purpose: Treatment
Official Title: Hydroxychloroquine Treatment for Severe COVID-19 Respiratory Disease: Randomised Clinical Trial (HYDRA Trial)
Estimated Study Start Date : March 23, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : March 22, 2021


Arm Intervention/treatment
Active Comparator: treatment
Hydroxychloroquine tablet 200mg every 12 hours for 10 days.
Drug: Hydroxychloroquine
hydroxychloroquine 400mg day for 10 days

Placebo Comparator: placebo
identical placebo, one tablet every 12 hours for 10 days
Drug: Placebo oral tablet
Placebo oral tablet




Primary Outcome Measures :
  1. All-cause hospital mortality [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]
    incidence of all-cause mortality


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]
    Days from ER admission to hospital discharge

  2. Need of mechanical ventilation [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]
    need of invasive or non invasive mechanical ventilation

  3. Ventilator free days [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]
    28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization

  4. Grade 3-4 adverse reaction [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]
    Adverse Reactions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. negative pregnancy test in women
  3. COVID-19 confirmed by rtPCR in any respiratory sample.
  4. Severe COVID-19 disease defined as any from the following:

    1. Pulse oximetry less than 91% or a 3% drop from base pulse oximetry or need to increase supplementary oxygen in chronic hypoxia
    2. Need for mechanical ventilation (invasive or non invasive )
    3. Sepsis/septic shock.

Exclusion Criteria:

  1. history of anaphylactic shock to hydroxychloroquine.
  2. History of previous administration of chloroquine or hydroxychloroquine (within 1 month)
  3. decision of attending physician by any reason.
  4. History of chronic hepatic disease (Child-Pugh B or C)
  5. History of Chronic renal disease (GFR less than 30)

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): NCT04315896


Contacts
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Contact: Carmen Hernandez-Cárdenas, MD. MSc 54871700 ext 5213 cmhcar@hotmail.com
Contact: Rogelio Perez-Padilla, MD. PhD. 54871700 perezpad@gmail.com

Sponsors and Collaborators
National Institute of Respiratory Diseases, Mexico
Sanofi
Investigators
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Principal Investigator: Carmen Hernandez-Cárdenas, MD. MSc. National Institute of Respiratory Diseases - México
Study Director: Luis-Felipe Jurado-Camacho, MD National Institute of Respiratory Diseases - México
Study Chair: Ireri Thirion-Romero, MD. MSc National Institute of Respiratory Diseases - México
Study Chair: Sebastian Rodriguez-Llamazares, MD.MPH National Institute of Respiratory Diseases - México
Study Director: Rogelio Perez-Padilla, MD. PhD National Institute of Respiratory Diseases - México
Study Chair: Cristobal Guadarrama, MD MSc National Institute of Respiratory Diseases - México
Study Chair: Joel Vasquez-Pérez, MD National Institute of Respiratory Diseases - México

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Responsible Party: National Institute of Respiratory Diseases, Mexico
ClinicalTrials.gov Identifier: NCT04315896    
Other Study ID Numbers: HidroxycloroquinaCOVID19
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: As requested by other investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by National Institute of Respiratory Diseases, Mexico:
COVID-19
Severe acute respiratory syndrome
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents