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

NCT04315896 | Completed Phase 3 DMC

• 1 other identifier: HidroxycloroquinaCOVID19
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Keywords

COVID-19; Severe acute respiratory syndrome

Outcome Measures

Primary Outcomes (1)

• All-cause hospital mortality

  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 Outcomes (4)

• Length of hospital stay

  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

  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

  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

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

Study Arms (2)

treatment

ACTIVE COMPARATOR

Hydroxychloroquine tablet 200mg every 12 hours for 10 days.

Drug: Hydroxychloroquine

placebo

PLACEBO COMPARATOR

identical placebo, one tablet every 12 hours for 10 days

Drug: Placebo oral tablet

Interventions

Hydroxychloroquine DRUG

hydroxychloroquine 400mg day for 10 days

treatment

Placebo oral tablet DRUG

Placebo oral tablet

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Respiratory Diseases, Mexico: lead

Study Sites (1)

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Carmen Hernandez-Cárdenas, MD. MSc.

  National Institute of Respiratory Diseases - México

  PRINCIPAL INVESTIGATOR

• Luis-Felipe Jurado-Camacho, MD

  National Institute of Respiratory Diseases - México

  STUDY DIRECTOR

• 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 CHAIR

• Rogelio Perez-Padilla, MD. PhD

  National Institute of Respiratory Diseases - México

  STUDY DIRECTOR

• Cristobal Guadarrama, MD MSc

  National Institute of Respiratory Diseases - México

  STUDY CHAIR

• Joel Vasquez-Pérez, MD

  National Institute of Respiratory Diseases - México

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Double blinded, randomized controlled trial

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 20, 2020
• Study Start: April 14, 2020
• Primary Completion: July 1, 2020
• Study Completion: August 15, 2020
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

ME (1)