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

January 17, 2022 updated by: National Institute of Respiratory Diseases, Mexico

Hydroxychloroquine Treatment for Severe COVID-19 Respiratory Disease: Randomised Clinical Trial (HYDRA Trial)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico, City, Mexico, 14080
        • Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 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
From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
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
From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
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
From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Respiratory Diseases, Mexico

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2020

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

August 15, 2020

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 18, 2020

First Posted (Actual)

March 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 17, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HidroxycloroquinaCOVID19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

As requested by other investigators.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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