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Public Health Emergency: SOLIDARITY TRIAL Philippines

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
Remdesivir
Hydroxychloroquine
Lopinavir / Ritonavir
Interferon beta-1a
Acalabrutinib
Sponsored by
University of the Philippines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Solidarity, Hydroxychloroquine, Lopinavir+Ritonavir, Interferon Beta 1a, Remdesivir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

LSoC

Rem+LSoC

HCQ+LSoC

Lopi/Rito+LSoC

Lopi/Rito+IFN+LSoC

IFN+LSoC

ACB+LSoC

Arm Description

Local Standard of Care

Remdesivir with Local Standard of Care

Hydroxychloroquine with Local Standard of Care

Lopinavir/Ritonavir with Local Standard of Care

Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care

Interferon Beta 1a with Local Standard of Care

Acalabrutinib with Local Standard of Care

Outcomes

Primary Outcome Measures

All-cause mortality

Secondary Outcome Measures

Duration of hospital stay
Time to first receiving ventilation

Full Information

First Posted
August 21, 2021
Last Updated
February 27, 2022
Sponsor
University of the Philippines
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1. Study Identification

Unique Protocol Identification Number
NCT05024006
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 23, 2020 (Actual)
Primary Completion Date
April 17, 2021 (Actual)
Study Completion Date
April 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Philippines

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Solidarity, Hydroxychloroquine, Lopinavir+Ritonavir, Interferon Beta 1a, Remdesivir

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Adaptive design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LSoC
Arm Type
No Intervention
Arm Description
Local Standard of Care
Arm Title
Rem+LSoC
Arm Type
Experimental
Arm Description
Remdesivir with Local Standard of Care
Arm Title
HCQ+LSoC
Arm Type
Experimental
Arm Description
Hydroxychloroquine with Local Standard of Care
Arm Title
Lopi/Rito+LSoC
Arm Type
Experimental
Arm Description
Lopinavir/Ritonavir with Local Standard of Care
Arm Title
Lopi/Rito+IFN+LSoC
Arm Type
Experimental
Arm Description
Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care
Arm Title
IFN+LSoC
Arm Type
Experimental
Arm Description
Interferon Beta 1a with Local Standard of Care
Arm Title
ACB+LSoC
Arm Type
Experimental
Arm Description
Acalabrutinib with Local Standard of Care
Intervention Type
Drug
Intervention Name(s)
Remdesivir
Intervention Description
Two intravenous loading doses, then daily infusion for 10 days
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Two oral loading doses, then orally twice daily for 10 days
Intervention Type
Drug
Intervention Name(s)
Lopinavir / Ritonavir
Intervention Description
Orally twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1a
Intervention Description
Daily injection for 6 days
Intervention Type
Drug
Intervention Name(s)
Acalabrutinib
Intervention Description
Orally twice daily for 10 days
Primary Outcome Measure Information:
Title
All-cause mortality
Time Frame
Number of days from hospital admission up to 28 days post discharge
Secondary Outcome Measure Information:
Title
Duration of hospital stay
Time Frame
Number of days from hospital admission to discharge up to 28 days post admission
Title
Time to first receiving ventilation
Time Frame
Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consenting adults (age ≥18) hospitalised with the following criteria will be included in the study: Probable or confirmed COVID-19 regardless of severity, i.e., mild, moderate and severe cases Not already receiving any of the study drugs Without known allergy or contraindications to any of the study drugs (in the view of the physician responsible for their care), and Without anticipated transfer within 72 hours to a non-study hospital. Exclusion Criteria: Patients with contraindications to any of the study drugs.
Facility Information:
Facility Name
Baguio General Hospital
City
Baguio City
State/Province
Benguet
Country
Philippines
Facility Name
Cebu Doctor's University Hospital
City
Cebu City
State/Province
Cebu
Country
Philippines
Facility Name
Perpetual Succor Hospital Cebu
City
Cebu City
State/Province
Cebu
Country
Philippines
Facility Name
Vicente Sotto Memorial Medical Center
City
Cebu City
State/Province
Cebu
Country
Philippines
Facility Name
Southern Philippines Medical Center
City
Davao City
State/Province
Davao
Country
Philippines
Facility Name
West Visayas University Medical Center
City
Iloilo City
State/Province
Iloilo
Country
Philippines
Facility Name
Makati Medical Center
City
Makati City
State/Province
Metro Manila
Country
Philippines
Facility Name
Chinese General Hospital
City
Manila
State/Province
Metro Manila
Country
Philippines
Facility Name
Manila Doctors Hospital
City
Manila
State/Province
Metro Manila
Country
Philippines
Facility Name
ManilaMed - Medical Center Philippines
City
Manila
State/Province
Metro Manila
Country
Philippines
Facility Name
San Lazaro Hospital
City
Manila
State/Province
Metro Manila
Country
Philippines
Facility Name
UP - Philippine General Hospital
City
Manila
State/Province
Metro Manila
Country
Philippines
Facility Name
Asian Hospital and Medical Center
City
Muntinlupa
State/Province
Metro Manila
Country
Philippines
Facility Name
Research Institute for Tropical Medicine
City
Muntinlupa
State/Province
Metro Manila
Country
Philippines
Facility Name
San Juan de Dios Educational Foundation Inc - Hospital
City
Pasay
State/Province
Metro Manila
Country
Philippines
Facility Name
The Medical City
City
Pasig City
State/Province
Metro Manila
Country
Philippines
Facility Name
Diliman Doctors Hospital
City
Quezon City
State/Province
Metro Manila
Country
Philippines
Facility Name
Fe Del Mundo Medical Center
City
Quezon City
State/Province
Metro Manila
Country
Philippines
Facility Name
Lung Center of the Philippines
City
Quezon City
State/Province
Metro Manila
Country
Philippines
Facility Name
St Luke's Medical Center Quezon City
City
Quezon City
State/Province
Metro Manila
Country
Philippines
Facility Name
University of the East Ramon Magsaysay Memorial Medical Center
City
Quezon City
State/Province
Metro Manila
Country
Philippines
Facility Name
World Citi Medical Center
City
Quezon City
State/Province
Metro Manila
Country
Philippines
Facility Name
Cardinal Santos Medical Center
City
San Juan
State/Province
Metro Manila
Country
Philippines
Facility Name
St Luke's Medical Center Global
City
Taguig
State/Province
Metro Manila
Country
Philippines
Facility Name
Batangas Medical Center
City
Batangas
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
No

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Public Health Emergency: SOLIDARITY TRIAL Philippines

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