The University of the Philippines Hydroxychloroquine PEP Against COVID-19 Trial

NCT04364815 | Withdrawn Phase 3

• 1 other identifier: RGAO-2020-0339
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COVID-19

Keywords

COVID-19; SARS-COV-2; Hydroxychloroquine; Post-exposure prophylaxis; Healthcare workers

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  30 days

• Time to COVID-19 infection in patients receiving study drug (in days)

  30 days

• Safety and tolerability of study drug (to be reported as absolute number and frequency of events)

  30 days

Study Arms (2)

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)

Drug: Hydroxychloroquine plus standard preventive measures

Placebo plus standard preventive measure

PLACEBO COMPARATOR

Placebo tablet plus standard preventive measures as defined by PGH-HICU

Drug: Placebo plus standard preventive measures

Interventions

Hydroxychloroquine plus standard preventive measures DRUG

Hydroxychloroquine and standard preventive measures

Also known as: Hydroxychloroquine and standard preventive measures

Hydroxychloroquine plus standard preventive measures

Placebo plus standard preventive measures DRUG

Placebo tablet plus standard preventive measures as defined by PGH-HICU

Placebo plus standard preventive measure

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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:

Sponsors & Collaborators

• University of the Philippines: lead

Study Sites (1)

Philippine General Hospital - University of the Philippines Manila

Manila, Philippines

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Belen L Dofitas, MD

  Philippine General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomized allocation concealment 1. Computer-generated random numbers for two groups will be used by a third party to create an allocation list for participants 2. The pharmacist will prepare the test medication in sequentially numbered packages 3. The third party will be contacted upon enrollment of a participant for the assigned group Blinding 1. Placebo tablets will have the same appearance as the HCQ tablets 2. The pharmacist will prepare the test medications in sequentially numbered packages 3. Blinding of the outcome assessor will be achieved by using numerical codes on the Case Record Form of each patient with no indication of the group assignment on the Case Record Forms 4. Laboratory specimens, ECG strip, and RT-PCR test specimens will be labeled with the numerical code of the participant and test number
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, assessor- and patient- blinded, placebo controlled, parallel group trial

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 28, 2020
• Study Start: December 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)