COVID-19Phase 3NCT04364815
The University of the Philippines Hydroxychloroquine PEP Against COVID-19 Trial
A Phase 3 study testing Hydroxychloroquine plus standard preventive measures in people with COVID-19, run by University of the Philippines at 1 site in Philippines.
Trial summary
This COVID-19 pandemic warrants urgent strategies to protect people at high risk of infection, particularly the healthcare workers. Secondary prevention through post-exposure prophylaxis (PEP) and early treatment of infection are needed to prevent severe cases and cut secondary transmission. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine plus standard preventive measures
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 sitePhilippines
- Study dates
- Dec 2020to May 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- any medical or non-medical personnel of the Philippine General Hospital and the UP Manila National Institutes of Health to include physicians (consultants, fellows-in-training, residents-in-training); nurses and other nursing staff (nursing aide, institutional or utility worker); janitors and cleaning staff, medical technologists and personnel of the laboratory where the COVID PCR testing is done; technicians of the radiology department, electrocardiography (ECG) station, arterial blood gas (ABG) stations and other personnel employed by the hospital on a tenured, part-time or full-time,and temporary. Because of the sample size, there is also a plan to include also health care workers in the community quarantine centers in the Manila area such as the Rizal Coliseum or the Ninoy Aquino Stadium, or at the World Trade Center
- aged 18-59 years
- exposure to a probable or confirmed COVID19 case within 4 days prior to study enrollment that is considered to be medium or high risk as defined by the HICU
- asymptomatic (no acute respiratory, flu-like, gastrointestinal signs and symptoms at the time of enrollment
- negative baseline COVID19 RT-PCR test result*
- for female participants of child bearing potential they must agree to effective birth control methods during the clinical trial or abstinence from any sexual activity during the duration of the study.
- Since RT-PCR result may not be released right away, volunteers who test positive after preliminary enrollment will be screen-failed and will not be included in the analysis.
Who cannot join
- active COVID19 disease: positive RT-PCR COVID19 test
- prior COVID19 disease
- weight less than 40kg or a BMI less than 18kg/m2
- current or recent hospitalization within the past year
- known allergy to or intolerance of hydroxychloroquine (HCQ) or chloroquine (CQ)
- current use of HCQ or CQ for whatever indications (malaria, lupus)
Show all 19Show fewer
- current use of other medication with known antiviral effects
- current or known use in the last two weeks of known arrhythmogenic drugs or drugs that prolong the QT interval in the ECG, including but not limited to quinolones, macrolides, amiodarone, digoxin, flecainide, propafenone
- any previous known or suspected retinopathy; in case of doubt, an ophthalmology clearance be secured prior to enrollment
- known G6PD deficiency discovered through the newborn screening program or known intolerance or allergies to beans and any food that contains beans
- women who are pregnant or breastfeeding, or a positive pregnancy test at baseline for women of child bearing age
- history of known seizures or treatment with anti-epileptic medications
- history of known existing arrhythmia
- intake or use of anti diabetic agents especially sulfonylureas or any type of insulin
- presence of abnormalities in baseline tests:
- ECG abnormalities that are exclusionary: Baseline QTc > 500 msec or QTc > 550 msec in patients with wide QRS; any form of tachy- or bradyarrythmias NB: sinus arrhythmia is not exclusionary
- CBC abnormalities showing anemia with hemoglobin value less than 12.5 g/dL or low platelet count or thrombocytopenia with platelet count less than 150,000 platelets per microliter
- Creatinine levels above normal values: 60 to 110 micromoles per liter (0.7 to 1.2 mg/dL for men and 45 to 90 micromoles per liter (0.5 to 1.0 mg/dL) for women
- ALT test that is elevated above 2x the upper limit of the normal: NV is 7 to 56 units per liter
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Philippine General Hospital - University of the Philippines Manila
Manila
About this study
Official title: Efficacy and Safety of Hydroxychloroquine for COVID-19 Post-Exposure Prophylaxis of Healthcare Workers in the Philippine General Hospital and UP Manila National Institutes of Health: A Randomized, Double-blind, Placebo-controlled Trial
This COVID-19 pandemic warrants urgent strategies to protect people at high risk of infection, particularly the healthcare workers. Secondary prevention through post-exposure prophylaxis (PEP) and early treatment of infection are needed to prevent severe cases and cut secondary transmission. Hydroxycholoroquine (HCQ) is an inexpensive anti-malarial drug with immunomodulatory effects that are currently used as an off-label treatment for symptomatic COVID-19 patients. In vitro studies have shown that it can efficiently inhibit SARS-CoV-2 infection and has potential as a post-exposure prophylaxis drug.
Read the detailed description
To compare the efficacy and safety of hydroxychloroquine with an oral loading dose of 400 mg two times a day on D1 followed by 400mg/day from Day 2-10 plus standard preventive measures and standard preventive measures alone as post-exposure prophylaxis for healthcare workers in a Metro Manila COVID Referral Center
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine plus standard preventive measures, Placebo plus standard preventive measures
- Keywords
- COVID-19, SARS-COV-2, Hydroxychloroquine, Post-exposure prophylaxis, Healthcare workers
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine plus standard preventive measuresDrug
Also called Hydroxychloroquine and standard preventive measures
Hydroxychloroquine and standard preventive measures
Placebo plus standard preventive measuresDrug
Placebo tablet plus standard preventive measures as defined by PGH-HICU
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine plus standard preventive measures | Experimental | Hydroxychloroquine oral loading dose of 400mg two times per day on Day 1 then 400 mg once a day for Day 2-10 plus standard preventive measures as defined by PGH Hospital Infection Control Unit (HICU) Receives: Drug: Hydroxychloroquine plus standard preventive measures |
| Placebo plus standard preventive measure | Placebo comparator | Placebo tablet plus standard preventive measures as defined by PGH-HICU Receives: Drug: Placebo plus standard preventive measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of HCQ Prophylaxis in Preventing COVID-19 infection
Incidence of COVID-19 infection confirmed by RT-PCR COVID-19 test within the PEP treatment period (28 days) with or without symptoms of COVID-19 infection
Measured: 30 days
Secondary outcomes (3)
Efficacy of study drug as post-exposure prophylaxis in preventing COVID-19 related symptoms (to be reported as absolute number and frequency of events)
Incidence of patient self-reported COVID-19 related symptoms anytime during follow up period as measured by a standardized patient diary
Measured: 30 days
Time to COVID-19 infection in patients receiving study drug (in days)
Interval from exposure to COVID-19 case Interval from first dose of study drug
Measured: 30 days
Safety and tolerability of study drug (to be reported as absolute number and frequency of events)
Incidence of study drug discontinuation Incidence of all adverse events based on patients a) self-report using daily symptom diary and b) study physicians
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study startDec 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: Investigators opted to change the design of the study.
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
- Randomized, assessor- and patient- blinded, placebo controlled, parallel group trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Belen L Dofitas, MD, Principal investigator, Philippine General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364815
- Sponsor's protocol ID
- RGAO-2020-0339
- Status last verified
- Nov 2020
- First submitted
- 22 Apr 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hydroxychloroquine for COVID-19 Post-Exposure Prophylaxis of Healthcare Workers in the Philippine General Hospital and UP Manila National Institutes of Health: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04364815
- Acronym / sponsor ID
- RGAO-2020-0339
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2, Hydroxychloroquine, Post-exposure prophylaxis, Healthcare workers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigators opted to change the design of the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 28 Apr 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.
This COVID-19 pandemic warrants urgent strategies to protect people at high risk of infection, particularly the healthcare workers. Secondary prevention through post-exposure prophylaxis (PEP) and early treatment of infection are needed to prevent severe cases and cut secondary transmission. Hydroxycholoroquine (HCQ) is an inexpensive anti-malarial drug with immunomodulatory effects that are currently used as an off-label treatment for symptomatic COVID-19 patients. In vitro studies have shown that it can efficiently inhibit SARS-CoV-2 infection and has potential as a post-exposure prophylaxis drug.
Detailed description
To compare the efficacy and safety of hydroxychloroquine with an oral loading dose of 400 mg two times a day on D1 followed by 400mg/day from Day 2-10 plus standard preventive measures and standard preventive measures alone as post-exposure prophylaxis for healthcare workers in a Metro Manila COVID Referral Center
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, assessor- and patient- blinded, placebo controlled, parallel group trial
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine plus standard preventive measures | Experimental | Drug: Hydroxychloroquine plus standard preventive measuresHydroxychloroquine oral loading dose of 400mg two times per day on Day 1 then 400 mg once a day for Day 2-10 plus standard preventive measures as defined by PGH Hospital Infection Control Unit (HICU) |
| Placebo plus standard preventive measure | Placebo comparator | Drug: Placebo plus standard preventive measuresPlacebo tablet plus standard preventive measures as defined by PGH-HICU |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- any medical or non-medical personnel of the Philippine General Hospital and the UP Manila National Institutes of Health to include physicians (consultants, fellows-in-training, residents-in-training); nurses and other nursing staff (nursing aide, institutional or utility worker); janitors and cleaning staff, medical technologists and personnel of the laboratory where the COVID PCR testing is done; technicians of the radiology department, electrocardiography (ECG) station, arterial blood gas (ABG) stations and other personnel employed by the hospital on a tenured, part-time or full-time,and temporary. Because of the sample size, there is also a plan to include also health care workers in the community quarantine centers in the Manila area such as the Rizal Coliseum or the Ninoy Aquino Stadium, or at the World Trade Center
- aged 18-59 years
- exposure to a probable or confirmed COVID19 case within 4 days prior to study enrollment that is considered to be medium or high risk as defined by the HICU
- asymptomatic (no acute respiratory, flu-like, gastrointestinal signs and symptoms at the time of enrollment
- negative baseline COVID19 RT-PCR test result*
Key exclusion criteria (19 listed)
- active COVID19 disease: positive RT-PCR COVID19 test
- prior COVID19 disease
- weight less than 40kg or a BMI less than 18kg/m2
- current or recent hospitalization within the past year
- known allergy to or intolerance of hydroxychloroquine (HCQ) or chloroquine (CQ)
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 |
|---|---|---|
| Hydroxychloroquine plus standard preventive measuresAlso: Hydroxychloroquine and standard preventive measuresHydroxychloroquine and standard preventive measures | Drug | Hydroxychloroquine plus standard preventive measures |
| Placebo plus standard preventive measuresPlacebo tablet plus standard preventive measures as defined by PGH-HICU | Drug | Placebo plus standard preventive measure |
Primary outcome
Efficacy of HCQ Prophylaxis in Preventing COVID-19 infection
Time frame: 30 days
Incidence of COVID-19 infection confirmed by RT-PCR COVID-19 test within the PEP treatment period (28 days) with or without symptoms of COVID-19 infection
3 secondary outcomes
Efficacy of study drug as post-exposure prophylaxis in preventing COVID-19 related symptoms (to be reported as absolute number and frequency of events)
Time frame: 30 days
Time to COVID-19 infection in patients receiving study drug (in days)
Time frame: 30 days
Safety and tolerability of study drug (to be reported as absolute number and frequency of events)
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Belen L Dofitas, MD principal investigator
Philippine General Hospital
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 plus standard preventive measures in people with COVID-19, run by University of the Philippines at 1 site in Philippines.
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 19 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: withdrawn, as of the sponsor's last update on 6 Nov 2020. 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 Philippines. 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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of HCQ Prophylaxis in Preventing COVID-19 infection (time frame: 30 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 6 Nov 2020.