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

NCT04315896 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2022-02-01

No results posted yet for this study

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

Interventions

DRUG

Hydroxychloroquine

hydroxychloroquine 400mg day for 10 days

DRUG

Placebo oral tablet

Placebo oral tablet

Sponsors & Collaborators

  • National Institute of Respiratory Diseases, Mexico

    lead OTHER_GOV

Principal Investigators

  • Carmen Hernandez-Cárdenas, MD. MSc. · National Institute of Respiratory Diseases - México

  • Luis-Felipe Jurado-Camacho, MD · National Institute of Respiratory Diseases - México

  • Ireri Thirion-Romero, MD. MSc · National Institute of Respiratory Diseases - México

  • Sebastian Rodriguez-Llamazares, MD.MPH · National Institute of Respiratory Diseases - México

  • Rogelio Perez-Padilla, MD. PhD · National Institute of Respiratory Diseases - México

  • Cristobal Guadarrama, MD MSc · National Institute of Respiratory Diseases - México

  • Joel Vasquez-Pérez, MD · National Institute of Respiratory Diseases - México

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-14
Primary Completion
2020-07-01
Completion
2020-08-15

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04315896 on ClinicalTrials.gov