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NCT Number: NCT04315896

Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Mexico City, 14080, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • negative pregnancy test in women
  • COVID-19 confirmed by rtPCR in any respiratory sample.
  • Severe COVID-19 disease defined as any from the following:
  • Pulse oximetry less than 91% or a 3% drop from base pulse oximetry or need to increase supplementary oxygen in chronic hypoxia
  • Need for mechanical ventilation (invasive or non invasive )
  • Sepsis/septic shock.

Exclusion criteria

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

Treatment and study plan

Hydroxychloroquine

Drug

hydroxychloroquine 400mg day for 10 days

Placebo oral tablet

Drug

Placebo oral tablet

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute of Respiratory Diseases, Mexico

Other Gov

Registry information

Official study title

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

Acronym: HYDRA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 20, 2020
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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