Clinical trial NCT05024006: Public Health Emergency: SOLIDARITY TRIAL Philippines
Official title: An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care Philippines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Solidarity
Hydroxychloroquine
Lopinavir+Ritonavir
Interferon Beta 1a
Remdesivir
Lead sponsor: University of the Philippines
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 1314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adaptive design
Primary purpose: TREATMENT

Brief summary: This study is an adaptive, randomized, open-label, controlled clinical trial utilizing an adaptive design to compare effects of repurposed drugs with local standard of care alone on major inpatient hospital outcomes. This is performed worldwide in collaboration with WHO.


Eligibility criteria: Inclusion Criteria:

* Consenting adults (age ≥18) hospitalised with the following criteria will be included in the study:

  1. Probable or confirmed COVID-19 regardless of severity, i.e., mild, moderate and severe cases
  2. Not already receiving any of the study drugs
  3. Without known allergy or contraindications to any of the study drugs (in the view of the physician responsible for their care), and
  4. Without anticipated transfer within 72 hours to a non-study hospital.

Exclusion Criteria:

* Patients with contraindications to any of the study drugs.

Primary outcomes:
measure: All-cause mortality
timeFrame: Number of days from hospital admission up to 28 days post discharge
Secondary outcomes:
measure: Duration of hospital stay
timeFrame: Number of days from hospital admission to discharge up to 28 days post admission
measure: Time to first receiving ventilation
timeFrame: Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission
Other outcomes:
Locations:
city: Baguio City
country: Philippines
facility: Baguio General Hospital
state: Benguet
city: Cebu City
country: Philippines
facility: Cebu Doctor's University Hospital
state: Cebu
city: Cebu City
country: Philippines
facility: Perpetual Succor Hospital Cebu
state: Cebu
city: Cebu City
country: Philippines
facility: Vicente Sotto Memorial Medical Center
state: Cebu
city: Davao City
country: Philippines
facility: Southern Philippines Medical Center
state: Davao
city: Iloilo City
country: Philippines
facility: West Visayas University Medical Center
state: Iloilo
city: Makati City
country: Philippines
facility: Makati Medical Center
state: Metro Manila
city: Manila
country: Philippines
facility: Chinese General Hospital
state: Metro Manila
city: Manila
country: Philippines
facility: Manila Doctors Hospital
state: Metro Manila
city: Manila
country: Philippines
facility: ManilaMed - Medical Center Philippines
state: Metro Manila
city: Manila
country: Philippines
facility: San Lazaro Hospital
state: Metro Manila
city: Manila
country: Philippines
facility: UP - Philippine General Hospital
state: Metro Manila
city: Muntinlupa
country: Philippines
facility: Asian Hospital and Medical Center
state: Metro Manila
city: Muntinlupa
country: Philippines
facility: Research Institute for Tropical Medicine
state: Metro Manila
city: Pasay
country: Philippines
facility: San Juan de Dios Educational Foundation Inc - Hospital
state: Metro Manila
city: Pasig City
country: Philippines
facility: The Medical City
state: Metro Manila
city: Quezon City
country: Philippines
facility: Diliman Doctors Hospital
state: Metro Manila
city: Quezon City
country: Philippines
facility: Fe Del Mundo Medical Center
state: Metro Manila
city: Quezon City
country: Philippines
facility: Lung Center of the Philippines
state: Metro Manila
city: Quezon City
country: Philippines
facility: St Luke's Medical Center Quezon City
state: Metro Manila
city: Quezon City
country: Philippines
facility: University of the East Ramon Magsaysay Memorial Medical Center
state: Metro Manila
city: Quezon City
country: Philippines
facility: World Citi Medical Center
state: Metro Manila
city: San Juan
country: Philippines
facility: Cardinal Santos Medical Center
state: Metro Manila
city: Taguig
country: Philippines
facility: St Luke's Medical Center Global
state: Metro Manila
city: Batangas
country: Philippines
facility: Batangas Medical Center
Study officials:
References: