Public Health Emergency: SOLIDARITY TRIAL Philippines

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Drug: Remdesivir; Drug: Lopinavir / Ritonavir; Drug: Hydroxychloroquine; Drug: Acalabrutinib; Drug: Interferon beta-1a

• Registration Number: NCT05024006
• Lead Sponsor: University of the Philippines

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-23
• Primary Completion: 2021-04-17
• Study Completion: 2021-04-17
• Study First Submitted: 2021-08-21
• Study First Submitted QC: 2021-08-21
• Study First Posted: 2021-08-27
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-27
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1314

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rem+LSoC	Remdesivir	Remdesivir with Local Standard of Care
Lopi/Rito+IFN+LSoC	Lopinavir / Ritonavir	Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care
Lopi/Rito+LSoC	Lopinavir / Ritonavir	Lopinavir/Ritonavir with Local Standard of Care
HCQ+LSoC	Hydroxychloroquine	Hydroxychloroquine with Local Standard of Care
ACB+LSoC	Acalabrutinib	Acalabrutinib with Local Standard of Care
IFN+LSoC	Interferon beta-1a	Interferon Beta 1a with Local Standard of Care
Lopi/Rito+IFN+LSoC	Interferon beta-1a	Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care

Primary Outcome Measures

Name	Time	Method
All-cause mortality	Number of days from hospital admission up to 28 days post discharge

Secondary Outcome Measures

Name	Time	Method
Time to first receiving ventilation	Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission
Duration of hospital stay	Number of days from hospital admission to discharge up to 28 days post admission

Trial Locations

Locations (25)

Chinese General Hospital; 🇵🇭 Manila, Metro Manila, Philippines

UP - Philippine General Hospital; 🇵🇭 Manila, Metro Manila, Philippines

San Juan de Dios Educational Foundation Inc - Hospital; 🇵🇭 Pasay, Metro Manila, Philippines

Baguio General Hospital; 🇵🇭 Baguio City, Benguet, Philippines

West Visayas University Medical Center; 🇵🇭 Iloilo City, Iloilo, Philippines

Makati Medical Center; 🇵🇭 Makati City, Metro Manila, Philippines

Southern Philippines Medical Center; 🇵🇭 Davao City, Davao, Philippines

Lung Center of the Philippines; 🇵🇭 Quezon City, Metro Manila, Philippines

St Luke's Medical Center Quezon City; 🇵🇭 Quezon City, Metro Manila, Philippines

Vicente Sotto Memorial Medical Center; 🇵🇭 Cebu City, Cebu, Philippines

Asian Hospital and Medical Center; 🇵🇭 Muntinlupa, Metro Manila, Philippines

World Citi Medical Center; 🇵🇭 Quezon City, Metro Manila, Philippines

Manila Doctors Hospital; 🇵🇭 Manila, Metro Manila, Philippines

Cebu Doctor's University Hospital; 🇵🇭 Cebu City, Cebu, Philippines

Perpetual Succor Hospital Cebu; 🇵🇭 Cebu City, Cebu, Philippines

San Lazaro Hospital; 🇵🇭 Manila, Metro Manila, Philippines

The Medical City; 🇵🇭 Pasig City, Metro Manila, Philippines

Research Institute for Tropical Medicine; 🇵🇭 Muntinlupa, Metro Manila, Philippines

Fe Del Mundo Medical Center; 🇵🇭 Quezon City, Metro Manila, Philippines

University of the East Ramon Magsaysay Memorial Medical Center; 🇵🇭 Quezon City, Metro Manila, Philippines

St Luke's Medical Center Global; 🇵🇭 Taguig, Metro Manila, Philippines

Batangas Medical Center; 🇵🇭 Batangas, Philippines

Cardinal Santos Medical Center; 🇵🇭 San Juan, Metro Manila, Philippines

ManilaMed - Medical Center Philippines; 🇵🇭 Manila, Metro Manila, Philippines

Diliman Doctors Hospital; 🇵🇭 Quezon City, Metro Manila, Philippines