Public Health Emergency: SOLIDARITY TRIAL Philippines

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05024006
• Other study ID #: SJREB-2020-20
• Status: Completed
• Phase: N/A
• Start date: April 23, 2020
• Est. completion date: April 17, 2021

Study information

• Verified date: February 2022
• Source: University of the Philippines
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1314
• Est. completion date: April 17, 2021
• Est. primary completion date: April 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Remdesivir
Two intravenous loading doses, then daily infusion for 10 days
• Hydroxychloroquine
Two oral loading doses, then orally twice daily for 10 days
• Lopinavir / Ritonavir
Orally twice daily for 14 days
• Interferon beta-1a
Daily injection for 6 days
• Acalabrutinib
Orally twice daily for 10 days

Locations

Country	Name	City	State
Philippines	Baguio General Hospital	Baguio City	Benguet
Philippines	Batangas Medical Center	Batangas
Philippines	Cebu Doctor's University Hospital	Cebu City	Cebu
Philippines	Perpetual Succor Hospital Cebu	Cebu City	Cebu
Philippines	Vicente Sotto Memorial Medical Center	Cebu City	Cebu
Philippines	Southern Philippines Medical Center	Davao City	Davao
Philippines	West Visayas University Medical Center	Iloilo City	Iloilo
Philippines	Makati Medical Center	Makati City	Metro Manila
Philippines	Chinese General Hospital	Manila	Metro Manila
Philippines	Manila Doctors Hospital	Manila	Metro Manila
Philippines	ManilaMed - Medical Center Philippines	Manila	Metro Manila
Philippines	San Lazaro Hospital	Manila	Metro Manila
Philippines	UP - Philippine General Hospital	Manila	Metro Manila
Philippines	Asian Hospital and Medical Center	Muntinlupa	Metro Manila
Philippines	Research Institute for Tropical Medicine	Muntinlupa	Metro Manila
Philippines	San Juan de Dios Educational Foundation Inc - Hospital	Pasay	Metro Manila
Philippines	The Medical City	Pasig City	Metro Manila
Philippines	Diliman Doctors Hospital	Quezon City	Metro Manila
Philippines	Fe Del Mundo Medical Center	Quezon City	Metro Manila
Philippines	Lung Center of the Philippines	Quezon City	Metro Manila
Philippines	St Luke's Medical Center Quezon City	Quezon City	Metro Manila
Philippines	University of the East Ramon Magsaysay Memorial Medical Center	Quezon City	Metro Manila
Philippines	World Citi Medical Center	Quezon City	Metro Manila
Philippines	Cardinal Santos Medical Center	San Juan	Metro Manila
Philippines	St Luke's Medical Center Global	Taguig	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
University of the Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		Number of days from hospital admission up to 28 days post discharge
Secondary	Duration of hospital stay		Number of days from hospital admission to discharge up to 28 days post admission
Secondary	Time to first receiving ventilation		Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission