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

Primary Purpose

COVID-19, Severe Acute Respiratory Syndrome

Status

Completed

Phase

Phase 3

Locations

Mexico

Study Type

Interventional

Intervention

Hydroxychloroquine

Placebo oral tablet

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Severe acute respiratory syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
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:

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)

Sites / Locations

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

treatment

placebo

Arm Description

Hydroxychloroquine tablet 200mg every 12 hours for 10 days.

identical placebo, one tablet every 12 hours for 10 days

Outcomes

Primary Outcome Measures

All-cause hospital mortality

incidence of all-cause mortality

Secondary Outcome Measures

Length of hospital stay

Days from ER admission to hospital discharge

Need of mechanical ventilation

need of invasive or non invasive mechanical ventilation

Ventilator free days

28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization

Grade 3-4 adverse reaction

Adverse Reactions

Full Information

NCT ID

NCT04315896

First Posted

March 18, 2020

Last Updated

January 17, 2022

Sponsor

National Institute of Respiratory Diseases, Mexico

1. Study Identification

Unique Protocol Identification Number

NCT04315896

Brief Title

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

Acronym

HYDRA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

April 14, 2020 (Actual)

Primary Completion Date

July 1, 2020 (Actual)

Study Completion Date

August 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Respiratory Diseases, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Severe Acute Respiratory Syndrome

Keywords

COVID-19, Severe acute respiratory syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Double blinded, randomized controlled trial

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

320 (Actual)

8. Arms, Groups, and Interventions

Arm Title

treatment

Arm Type

Active Comparator

Arm Description

Hydroxychloroquine tablet 200mg every 12 hours for 10 days.

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

identical placebo, one tablet every 12 hours for 10 days

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine

Intervention Description

hydroxychloroquine 400mg day for 10 days

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Intervention Description

Placebo oral tablet

Primary Outcome Measure Information:

Title

All-cause hospital mortality

Description

incidence of all-cause 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

Secondary Outcome Measure Information:

Title

Length of hospital stay

Description

Days from ER admission to hospital discharge

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

Title

Need of mechanical ventilation

Description

need of invasive or non invasive 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

Title

Ventilator free days

Description

28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization

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

Title

Grade 3-4 adverse reaction

Description

Adverse Reactions

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carmen Hernandez-Cárdenas, MD. MSc.

Organizational Affiliation