Clinical trial NCT04315896: Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial)
Official title: Hydroxychloroquine Treatment for Severe COVID-19 Respiratory Disease: Randomised Clinical Trial (HYDRA Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Severe Acute Respiratory Syndrome
Keywords: COVID-19
Severe acute respiratory syndrome
Lead sponsor: National Institute of Respiratory Diseases, Mexico
Sponsor class: OTHER_GOV
First posted: 2020-03-20
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded, randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: All-cause hospital mortality
timeFrame: 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:
measure: Length of hospital stay
timeFrame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
measure: Need of mechanical ventilation
timeFrame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
measure: Ventilator free days
timeFrame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
measure: Grade 3-4 adverse reaction
timeFrame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
Other outcomes:
Locations:
city: Mexico, City
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Study officials:
affiliation: National Institute of Respiratory Diseases - México
name: Carmen Hernandez-Cárdenas, MD. MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Respiratory Diseases - México
name: Luis-Felipe Jurado-Camacho, MD
role: STUDY_DIRECTOR
affiliation: National Institute of Respiratory Diseases - México
name: Ireri Thirion-Romero, MD. MSc
role: STUDY_CHAIR
affiliation: National Institute of Respiratory Diseases - México
name: Sebastian Rodriguez-Llamazares, MD.MPH
role: STUDY_CHAIR
affiliation: National Institute of Respiratory Diseases - México
name: Rogelio Perez-Padilla, MD. PhD
role: STUDY_DIRECTOR
affiliation: National Institute of Respiratory Diseases - México
name: Cristobal Guadarrama, MD MSc
role: STUDY_CHAIR
affiliation: National Institute of Respiratory Diseases - México
name: Joel Vasquez-Pérez, MD
role: STUDY_CHAIR
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