Public Health Emergency: SOLIDARITY TRIAL Philippines

February 27, 2022 updated by: Marissa Alejandria MD, University of the Philippines

An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care Philippines

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1314

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Batangas, Philippines
        • Batangas Medical Center
    • Benguet
      • Baguio City, Benguet, Philippines
        • Baguio General Hospital
    • Cebu
      • Cebu City, Cebu, Philippines
        • Cebu Doctor's University Hospital
      • Cebu City, Cebu, Philippines
        • Perpetual Succor Hospital Cebu
      • Cebu City, Cebu, Philippines
        • Vicente Sotto Memorial Medical Center
    • Davao
      • Davao City, Davao, Philippines
        • Southern Philippines Medical Center
    • Iloilo
      • Iloilo City, Iloilo, Philippines
        • West Visayas University Medical Center
    • Metro Manila
      • Makati City, Metro Manila, Philippines
        • Makati Medical Center
      • Manila, 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
      • Muntinlupa, Metro Manila, Philippines
        • Asian Hospital and Medical Center
      • Muntinlupa, Metro Manila, Philippines
        • Research Institute For Tropical Medicine
      • Pasay, Metro Manila, Philippines
        • San Juan de Dios Educational Foundation Inc - Hospital
      • Pasig City, Metro Manila, Philippines
        • The Medical City
      • Quezon 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
      • San Juan, Metro Manila, Philippines
        • Cardinal Santos Medical Center
      • Taguig, Metro Manila, Philippines
        • St Luke's Medical Center Global

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: LSoC
Local Standard of Care
Experimental: Rem+LSoC
Remdesivir with Local Standard of Care
Drug: Remdesivir
Two intravenous loading doses, then daily infusion for 10 days
Experimental: HCQ+LSoC
Hydroxychloroquine with Local Standard of Care
Drug: Hydroxychloroquine
Two oral loading doses, then orally twice daily for 10 days
Experimental: Lopi/Rito+LSoC
Lopinavir/Ritonavir with Local Standard of Care
Drug: Lopinavir / Ritonavir
Orally twice daily for 14 days
Experimental: Lopi/Rito+IFN+LSoC
Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care
Drug: Lopinavir / Ritonavir
Orally twice daily for 14 days
Drug: Interferon beta-1a
Daily injection for 6 days
Experimental: IFN+LSoC
Interferon Beta 1a with Local Standard of Care
Drug: Interferon beta-1a
Daily injection for 6 days
Experimental: ACB+LSoC
Acalabrutinib with Local Standard of Care
Drug: Acalabrutinib
Orally twice daily for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: Number of days from hospital admission up to 28 days post discharge
Number of days from hospital admission up to 28 days post discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of hospital stay
Time Frame: Number of days from hospital admission to discharge up to 28 days post admission
Number of days from hospital admission to discharge up to 28 days post admission
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
Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Philippines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2020

Primary Completion (Actual)

April 17, 2021

Study Completion (Actual)

April 17, 2021

Study Registration Dates

First Submitted

August 21, 2021

First Submitted That Met QC Criteria

August 21, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 27, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJREB-2020-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Remdesivir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe