COVID-19Phase 3HYDRANCT04315896
Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial)
A Phase 3 study testing Hydroxychloroquine in people with COVID-19 and Severe Acute Respiratory Syndrome, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19, Severe Acute Respiratory Syndrome
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteMexico
- Study dates
- 14 Apr 2020to 15 Aug 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Mexico City, 14080
About this study
Official title: Hydroxychloroquine Treatment for Severe COVID-19 Respiratory Disease: Randomised Clinical Trial (HYDRA Trial)
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.
Read the 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.
- Conditions
- COVID-19, Severe Acute Respiratory Syndrome
- Being tested
- Hydroxychloroquine, Placebo oral tablet
- Keywords
- COVID-19, Severe acute respiratory syndrome
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxychloroquine 400mg day for 10 days
Placebo oral tabletDrug
Placebo oral tablet
| Study group | Role | What they receive |
|---|---|---|
| treatment | Active comparator | Hydroxychloroquine tablet 200mg every 12 hours for 10 days. Receives: Drug: Hydroxychloroquine |
| placebo | Placebo comparator | identical placebo, one tablet every 12 hours for 10 days Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause hospital mortality
incidence of all-cause mortality
Measured: 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
Days from ER admission to hospital discharge
Measured: 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
need of invasive or non invasive mechanical ventilation
Measured: 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
28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization
Measured: 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
Adverse Reactions
Measured: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start14 Apr 2020
- Primary completion1 Jul 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Respiratory Diseases, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Carmen Hernandez-Cárdenas, MD. MSc., Principal investigator, National Institute of Respiratory Diseases - MéxicoLuis-Felipe Jurado-Camacho, MD, Study director, National Institute of Respiratory Diseases - MéxicoIreri Thirion-Romero, MD. MSc, Study chair, National Institute of Respiratory Diseases - MéxicoSebastian Rodriguez-Llamazares, MD.MPH, Study chair, National Institute of Respiratory Diseases - MéxicoRogelio Perez-Padilla, MD. PhD, Study director, National Institute of Respiratory Diseases - MéxicoCristobal Guadarrama, MD MSc, Study chair, National Institute of Respiratory Diseases - MéxicoJoel Vasquez-Pérez, MD, Study chair, National Institute of Respiratory Diseases - México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315896
- Sponsor's protocol ID
- HidroxycloroquinaCOVID19
- Acronym
- HYDRA
- Status last verified
- Jan 2022
- First submitted
- 18 Mar 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As requested by other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine Treatment for Severe COVID-19 Respiratory Disease: Randomised Clinical Trial (HYDRA Trial)
- ClinicalTrials.gov ID
- NCT04315896
- Acronym / sponsor ID
- HYDRA / HidroxycloroquinaCOVID19
- Conditions
- COVID-19, Severe Acute Respiratory Syndrome
- Keywords
- COVID-19, Severe acute respiratory syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- National Institute of Respiratory Diseases, MexicoOther government
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| treatment | Active comparator | Drug: HydroxychloroquineHydroxychloroquine tablet 200mg every 12 hours for 10 days. |
| placebo | Placebo comparator | Drug: Placebo oral tabletidentical placebo, one tablet every 12 hours for 10 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquinehydroxychloroquine 400mg day for 10 days | Drug | treatment |
| Placebo oral tabletPlacebo oral tablet | Drug | placebo |
Primary outcome
All-cause hospital 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
incidence of all-cause mortality
4 secondary outcomes
Length of hospital stay
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
Need of 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
Ventilator free days
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
Grade 3-4 adverse reaction
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: Undecided. As requested by other investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Hernandez-Cárdenas, MD. MSc. principal investigator
National Institute of Respiratory Diseases - México
Luis-Felipe Jurado-Camacho, MD study director
National Institute of Respiratory Diseases - México
Ireri Thirion-Romero, MD. MSc study chair
National Institute of Respiratory Diseases - México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine in people with COVID-19 and Severe Acute Respiratory Syndrome, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause hospital 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.