COVID-19Phase 3PHYDRANCT04318015
Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA 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
Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- 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
- 289 participants
- Where
- 1 siteMexico
- Study dates
- 14 Apr 2020to 31 Mar 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old upon study start
- Healthcare personnel exposed to patients with COVID-19 respiratory disease: physicians, nurses, chemists, pharmacists, janitors, stretcher-bearer, administrative and respiratory therapists.
- Signed consent for randomization to any study arm.
Who cannot join
- Known hypersensitivity to hydroxychloroquine manifested as anaphylaxis
- Current treatment to chloroquine or hydroxychloroquine
- Women with last menstruation date farther than a month without negative pregnancy test.
- Women with positive pregnancy test
- Breastfeeding women
- Chronic hepatic disease history (Child-Pugh B or C)
- Chronic renal disease (GFR less or equal to 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: Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)
Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.
Read the detailed description
Healthcare personnel infection with COVID-19 is a major setback in epidemiological emergencies. Hydroxychloroquine has proven to inhibit coronavirus in-vitro but no data to date has proven in-vivo effects. Nevertheless, hydroxychloroquine is a low cost, limited toxicity and broadly used agent. Since there is currently no treatment for COVID-19 exposure prophylaxis, the investigators will implement a triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) for 60 days.
- Conditions
- COVID-19, Severe Acute Respiratory Syndrome
- Being tested
- Hydroxychloroquine, Placebo oral tablet
- 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.
Also called Plaquenil
All treatment will be administered orally.
Placebo oral tabletDrug
Also called Placebo
All placebo will be administered orally
| Study group | Role | What they receive |
|---|---|---|
| High-risk Treatment | Experimental | Hydroxychloroquine 200mg per day for 60 days. Receives: Drug: Hydroxychloroquine |
| High-risk Placebo | Placebo comparator | Placebo tablet per day for 60 days. Receives: Drug: Placebo oral tablet |
| Low-risk Treatment | Experimental | Hydroxychloroquine 200mg per day for 60 days Receives: Drug: Hydroxychloroquine |
| Low-risk Placebo | Placebo comparator | Placebo tablet per day for 60 days. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic COVID-19 infection rate
Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test.
Measured: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start
Secondary outcomes (4)
Symptomatic non-COVID viral infection rate
Symptomatic infection rate by other non-COVID-19 viral etiologies defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive viral real time polymerase chain reaction test.
Measured: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start
Days of labor absenteeism
Number of days absent from labor due to COVID-19 symptomatic infection
Measured: From date of randomization until study completion 60 days after treatment start
Rate of labor absenteeism
Absenteeism from labor rate due to COVID-19 symptomatic infection
Measured: From date of randomization until study completion 60 days after treatment start
Rate of severe respiratory COVID-19 disease in healthcare personnel
Rate of severe respiratory COVID-19 disease in healthcare personnel
Measured: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start14 Apr 2020
- Primary completion31 Dec 2020
- Study completion31 Mar 2021
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Triple blinded, randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Respiratory Diseases, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jorge Rojas-Serrano, MD, PhD., Principal investigator, National Institute of Respiratory Diseases - MéxicoRogelio Perez-Padilla, MD, Study director, National Institute of Respiratory Diseases - MéxicoFelipe Jurado-Camacho, MD. MSc, Study director, National Institute of Respiratory Diseases - MéxicoIreri Thirion-Romero, MD, MSc, Study chair, National Institute of Respiratory Diseases - MéxicoSebastian Rodríguez-Llamazares, MD, MPH, Study chair, National Institute of Respiratory Diseases - MéxicoCarmen Hernandez Cárdenas, MD, MSc, Study chair, National Institute of Respiratory Diseases - MéxicoCristobal Guadarrama-Pérez, MD, Study chair, National Institute of Respiratory Diseases - MéxicoAlejandra Ramírez-Venegas, MD, MSc, Study chair, National Institute of Respiratory Diseases - México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318015
- Sponsor's protocol ID
- ProfilaxisCOVID
- Acronym
- PHYDRA
- Status last verified
- Apr 2020
- First submitted
- 19 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
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
- Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)
- ClinicalTrials.gov ID
- NCT04318015
- Acronym / sponsor ID
- PHYDRA / ProfilaxisCOVID
- Conditions
- COVID-19, Severe Acute Respiratory Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- National Institute of Respiratory Diseases, MexicoOther government
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 23 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.
Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.
Detailed description
Healthcare personnel infection with COVID-19 is a major setback in epidemiological emergencies. Hydroxychloroquine has proven to inhibit coronavirus in-vitro but no data to date has proven in-vivo effects. Nevertheless, hydroxychloroquine is a low cost, limited toxicity and broadly used agent. Since there is currently no treatment for COVID-19 exposure prophylaxis, the investigators will implement a triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) for 60 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Triple blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| High-risk Treatment | Experimental | Drug: HydroxychloroquineHydroxychloroquine 200mg per day for 60 days. |
| High-risk Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo tablet per day for 60 days. |
| Low-risk Treatment | Experimental | Drug: HydroxychloroquineHydroxychloroquine 200mg per day for 60 days |
| Low-risk Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo tablet per day for 60 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old upon study start
- Healthcare personnel exposed to patients with COVID-19 respiratory disease: physicians, nurses, chemists, pharmacists, janitors, stretcher-bearer, administrative and respiratory therapists.
- Signed consent for randomization to any study arm.
Key exclusion criteria (7 listed)
- Known hypersensitivity to hydroxychloroquine manifested as anaphylaxis
- Current treatment to chloroquine or hydroxychloroquine
- Women with last menstruation date farther than a month without negative pregnancy test.
- Women with positive pregnancy test
- Breastfeeding women
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 |
|---|---|---|
| HydroxychloroquineAlso: PlaquenilAll treatment will be administered orally. | Drug | High-risk Treatment, Low-risk Treatment |
| Placebo oral tabletAlso: PlaceboAll placebo will be administered orally | Drug | High-risk Placebo, Low-risk Placebo |
Primary outcome
Symptomatic COVID-19 infection rate
Time frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start
Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test.
4 secondary outcomes
Symptomatic non-COVID viral infection rate
Time frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start
Days of labor absenteeism
Time frame: From date of randomization until study completion 60 days after treatment start
Rate of labor absenteeism
Time frame: From date of randomization until study completion 60 days after treatment start
Rate of severe respiratory COVID-19 disease in healthcare personnel
Time frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start
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
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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.
Jorge Rojas-Serrano, MD, PhD. principal investigator
National Institute of Respiratory Diseases - México
Rogelio Perez-Padilla, MD study director
National Institute of Respiratory Diseases - México
Felipe Jurado-Camacho, MD. MSc study director
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 3 inclusion and 7 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?
Symptomatic COVID-19 infection rate (time frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start). 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.