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

COVID-19 Clinical Trial

— HYDRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04315896
• Other study ID #: HidroxycloroquinaCOVID19
• Status: Completed
• Phase: Phase 3
• Start date: April 14, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: January 2022
• Source: National Institute of Respiratory Diseases, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: August 15, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Hydroxychloroquine
hydroxychloroquine 400mg day for 10 days
• Placebo oral tablet
Placebo oral tablet

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"	Mexico, City

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Respiratory Diseases, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of hospital stay	Days from ER admission to hospital discharge	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	Need of mechanical ventilation	need of invasive or non invasive 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
Secondary	Ventilator free days	28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization	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	Grade 3-4 adverse reaction	Adverse Reactions	From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days