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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1314

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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