Public health emergency SOLIDARITY TRIAL

Registry ID

PHRR200520-002621

Secondary Identification Number

Unspecified

FDA Clinical Trial Reference (CTR) Number

2020-CT0536

Scientific Title

Public health emergency SOLIDARITY TRIAL: An International Randomised Trial of Additional Treatments for COVID-19 in Hospitalised Patients who are all Receiving the Local Standard of Care

Project Description

This study aims to compare the effects on major outcomes in hospital of the local standard of care alone versus the local standard of care plus one of four alternative anti- viral agents: 1.Remdesivir (daily infusion for 10 days), 2. Chloroquine or Hydroxychloroquine (two oral loading doses, then orally twice daily for 10 days), 3. Lopinavir with Ritonavir (orally twice daily for 14 days), 4. Lopinavir with Ritonavir (ditto) plus Interferon (daily injection for 6days). The primary objective of this large international randomized trial is to provide reliable estimates on any effects of these anti-viral treatments on in-hospital mortality in moderate and in severe COVID. The secondary objectives are to assess any effects of these anti-viral treatments on hospital duration and receipt of ventilation or intensive care, and to identify any serious adverse reactions.

Project Duration

Start Date	Duration in Months	Target Completion Date	Actual Completion Date
2020-04-23	12	2021-04-23	0000-00-00

Project Status

Ongoing

Implementing Agency (Primary Sponsor)

Institution	Classification	Region	LTO #
World Health Organization	Private Non-profit	NCR

Cooperating Agency (Secondary Sponsor)

Institution	Classification	Region	LTO #
Department of Health	Government	NCR

Funding Agency (Sources of Monetary or Material Support)

Institution	Region
World Health Organization	NCR
Department of Science and Technology	NCR
National Institutes of Health - University of the Philippines - Manila	NCR

Contact for Public Queries

Name	E-Mail	Institution and Institution Address
Madelaine Theresa Casimiro	mcasimiro.hpdpb@gmail.com	San Lazaro Compound, Rizal Ave. Sta Cruz, Manila 1003

Contact for Scientific Queries

Name	E-Mail	Institution and Institution Address
Dr. Marissa Alejandria	mmalejandria@up.edu.ph	UP-PGH Taft Ave, Ermita, Manila, 1000 Metro Manila

Investigating Team

Name	Expertise	Affiliation
Aileen D. Wang, MD	Pulmonary Medicine	University of the Philippines - Philippine General Hospital
Aileen Lee, MD	Infectious Diseases	Southern Philippines Medical Center
Anna Flor Malundo, MD	Infectious Diseases	University of the Philippines - Philippine General Hospital
Arthur Dessi E. Roman, MD	Infectious Diseases	Research Institute for Tropical Medicine
Bob Te, MD	Internal Medicine	Medical Center Manila
Bryan Albert Lim, MD	Infectious Diseases	Vicente Sotto Memorial Medical Center
Camilo C. Roa Jr., MD	Pulmonary Medicine	San Juan de Dios Hospital
Carmenchu Villavicencio, MD	Infectious diseases	St. Luke's Medical Center - Global City
Christine Ramos, MD	Infectious Diseases	San Juan de Dios Hospital
Cybele Lara R. Abad, MD	Infectious Diseases	The Medical City
Daisy Tagarda,MD	Infectious diseases	Diliman Doctors Hospital
Dennis Teo, MD	Pulmonary Medicine	Manila Doctors Hospital
Evalyn Roxas, MD	Infectious Diseases	Medical Center Manila
Fresthel Monica Climacosa	Molecular Microbiology and Immunology	University of the Philippines - Manila, College of Public Health
Gelza Mae A. Zabat, MD	Infectious Diseases	St. Luke's Medcal Center Quezon City
Gilly May Europa, MD	Pulmonary Medicine	Diliman Doctors Hospital
Guinevere Dy-Agra, MD	Pulmonary Medicine	St. Luke's Medical Center - Global City
Hazel Faye R. Docuyanan	Clinical Pharmacy	Makati Medical Center
Inofel Chin, MD	Infectious Diseases	Southern Philippines Medical Center
Jamie T. Arches	Infectious Diseases	San Lazaro Hospital
Janice Caoili, MD	Infectious Diseases	Makati Medical Center
Jemelyn Garcia, MD	Infectious Diseases	Research Institute for Tropical Medicine
Johanna Susan Ramos-Precilla, MD	Pulmonary Medicine	Manila Doctors Hospital
Jubert P. Benedicto, MD	Pulmonary Medicine	University of the Philippines - Philippine General Hospital
Justine Cabrerra, MD	Internal Medicine	University of the East Ramon Magsaysay Memorial Medical Center
Katha Ngo-Sanchez, MD	Infectious Diseases	Dr. Fe Del Mundo Medical Center Foundation Philippines
Kathryn Roa, MD	Infectious diseases	Southern Philippines Medical Center
Kingbherly L. Li, MD	Infectious Diseases	Chinese General Hospital and Medical Center
Kristine Bajandi, MD	Infectious Diseases	East Avenue Medical Center
Leonora Fernandez, MD	Pulmonary Medicine	Asian Hospital and Medical Center
Lourdes Ella Gonzales-Santos, MD	Cardiology	Cardinal Santos Medical Center
Maria Elizabeth Mercado	Emergency Medicine	National Institutes of Health - University of the Philippines - Manila
Maria Lowella de Leon	Pulmonary Medicine	Baguio General Hospital and Medical Center
Maria Rhona Bergantin, MD	Infectious Diseases	University of Santo Tomas Hospital
Maria Tarcela Gler, MD	Infectious Diseases	Makati Medical Center
Mario Panaligan	infectious Diseases	St. Luke's Medical Center - Global City
Marion Kwek, MD	Infectious DIseases	Asian Hospital and Medical Center
Marissa Elizabeth Lim, MD	Naprology	East Avenue Medical Center
Marissa M. Alejandria, MD	Infectious Diseases and Clinical Epidemiology	University of the Philippines - Philippine General Hospital
Marisse J. Nepomuceno, MD	Infectious Diseases	Manila Doctors Hospital
Marlon Arcegono, MD	Infectious Diseases	University of the Philippines - Philippine General Hospital
Mary Ann Lansang, MD	Infectious Diseases	The Medical City
Mary Claire Orden, MD	Pulmonary Medicine	Lung Center of the Philippines
Mary Lyndberg-Almero, MD	Internal Medicine	Batangas Medical Center
May Shiela Ariola-Ramos, MD	Infectious diseases	Cardinal Santos Medical Center
Minette Claire O. Rosario, MD	Infectious Diseases	University of the East Ramon Magsaysay Memorial Medical Center
Philina Pablo Villamor, MD	Pulmonary Medicine	Vicente Sotto Memorial Medical Center
Ralph Elvi Villalobos	Pulmonary Medicine	University of the Philippines - Philippine General Hospital
Richard Enecilla, MD	Emergency Medicine	St. Luke's Medical Center - Global City
Rontgene M. Solante, MD	Infectious Diseases	San Lazaro Hospital
Rosally Zamora, MD	Infectious Diseases	East Avenue Medical Center
Rozelle Jade Javier, MD	Infectious Diseases	Batangas Medical Center
Ruel Dionisio Paez, MD	Internal Medicine	San Juan de Dios Hospital
Rufina Issa Senga, MD	Infectious Diseases	World Citi Medical Center
Ryan Llorin, MD	Infectious Diseases	St. Luke's Medcal Center Quezon City
Sheena Marie Anne Santos, MD	Infectious Diseases	Dr. Fe Del Mundo Medical Center Foundation Philippines
Shiela Marie Reyes, MD	Rheumatology	World Citi Medical Center
Silveroseann Andales-Bacolcol, MD	Infectious Diseases	Manila Doctors Hospital
Susana Buno, MD	Infectious Diseases	University of the Philippines - Philippine General Hospital
Thea Pamela Cajulao, MD	Infectious Diseases	Baguio General Hospital and Medical Center
Theresa Amapola Nunez	Pharmacy	Medical Center Manila
Victor Catambingm MD	Internal medicine	University of the East Ramon Magsaysay Memorial Medical Center
Virgina de los Reyes, MD	Pulmonary Medicine	Lung Center of the Philippines

Project Location and Institutional Ethics Review Board

Project Location	Institutional Ethics Review Board
University of the Philippines - Philippine General Hospital	N/A
Southern Philippines Medical Center	DOH XI Cluster Ethics Review Committee
University of the Philippines - Philippine General Hospital	N/A
Research Institute for Tropical Medicine	Research Institute for Tropical Medicine Institutional Review Board
Medical Center Manila	Manila Medical Ethics Review Committee
Vicente Sotto Memorial Medical Center	Vicente Sotto Memorial Medical Center Ethics Committee
San Juan de Dios Hospital	San Juan de Dios Educational Foundation Inc., Hospital Ethics Review Committee
St. Luke's Medical Center - Global City	N/A
San Juan de Dios Hospital	San Juan de Dios Educational Foundation Inc., Hospital Ethics Review Committee
The Medical City	The Medical City - Institutional Review Board
Diliman Doctors Hospital	N/A
Manila Doctors Hospital	Manila Doctors Hospital Institutional Review Board
Medical Center Manila	Manila Medical Ethics Review Committee
University of the Philippines - Manila, College of Public Health	N/A
St. Luke's Medcal Center Quezon City	N/A
Diliman Doctors Hospital	N/A
St. Luke's Medical Center - Global City	N/A
Makati Medical Center	Makati Medical Center Institutional Review Board
Southern Philippines Medical Center	DOH XI Cluster Ethics Review Committee
San Lazaro Hospital	San Lazaro Hospital Research Ethics Review Unit
Makati Medical Center	Makati Medical Center Institutional Review Board
Research Institute for Tropical Medicine	Research Institute for Tropical Medicine Institutional Review Board
Manila Doctors Hospital	Manila Doctors Hospital Institutional Review Board
University of the Philippines - Philippine General Hospital	N/A
University of the East Ramon Magsaysay Memorial Medical Center	N/A
Dr. Fe Del Mundo Medical Center Foundation Philippines	N/A
Southern Philippines Medical Center	DOH XI Cluster Ethics Review Committee
Chinese General Hospital and Medical Center	Chinese General Hospital and Medical Center Institutional Review Board/Independent Ethics Committee
East Avenue Medical Center	East Avenue Medical Center (Ethics Review Committee)
Asian Hospital and Medical Center	Asian Hospital and Medical Center Institutional Review Board
Cardinal Santos Medical Center	Cardinal Santos Medical Center Ethics Review Committee
National Institutes of Health - University of the Philippines - Manila	National Institutes of Health
Baguio General Hospital and Medical Center	Baguio General Hospital and Medical Center Ethics Review Committee
University of Santo Tomas Hospital	University of Santo Tomas Hospital Institutional Review Board
Makati Medical Center	Makati Medical Center Institutional Review Board
St. Luke's Medical Center - Global City	N/A
Asian Hospital and Medical Center	Asian Hospital and Medical Center Institutional Review Board
East Avenue Medical Center	East Avenue Medical Center (Ethics Review Committee)
University of the Philippines - Philippine General Hospital	N/A
Manila Doctors Hospital	Manila Doctors Hospital Institutional Review Board
University of the Philippines - Philippine General Hospital	N/A
The Medical City	The Medical City - Institutional Review Board
Lung Center of the Philippines	Lung Center of the Philippines Ethics Review Committee
Batangas Medical Center	N/A
Cardinal Santos Medical Center	Cardinal Santos Medical Center Ethics Review Committee
University of the East Ramon Magsaysay Memorial Medical Center	N/A
Vicente Sotto Memorial Medical Center	Vicente Sotto Memorial Medical Center Ethics Committee
University of the Philippines - Philippine General Hospital	N/A
St. Luke's Medical Center - Global City	N/A
San Lazaro Hospital	San Lazaro Hospital Research Ethics Review Unit
East Avenue Medical Center	East Avenue Medical Center (Ethics Review Committee)
Batangas Medical Center	N/A
San Juan de Dios Hospital	San Juan de Dios Educational Foundation Inc., Hospital Ethics Review Committee
World Citi Medical Center	World Citi Medical Center Hospital Ethics Committee
St. Luke's Medcal Center Quezon City	N/A
Dr. Fe Del Mundo Medical Center Foundation Philippines	N/A
World Citi Medical Center	World Citi Medical Center Hospital Ethics Committee
Manila Doctors Hospital	Manila Doctors Hospital Institutional Review Board
University of the Philippines - Philippine General Hospital	N/A
Baguio General Hospital and Medical Center	Baguio General Hospital and Medical Center Ethics Review Committee
Medical Center Manila	Manila Medical Ethics Review Committee
University of the East Ramon Magsaysay Memorial Medical Center	N/A
Lung Center of the Philippines	Lung Center of the Philippines Ethics Review Committee

Health Condition(s) or Problem(s) Studied

COVID-19

Primary Outcomes

Major outcomes: The primary outcome is all-cause mortality, subdivided by severity of disease at the time of randomisation.

Key Secondary Outcomes

The major secondary outcomes are duration of hospital stay and time to first receiving ventilation (or intensive care).

Recruitment Status

Recruiting

Countries of Recruitment

Argentina
Brazil
Canada
Germany
Honduras
India
Indonesia
Iran
Ireland
Israel
Italy
Kenya
Lebanon
Malaysia
Norway
Peru
Philippines
Qatar
Saudi Arabia
South Africa
Spain
Switzerland
Thailand

Research Classification

Clinical Trial

FDA Document Tracking Number

20200417110924

FDA Approval Date

2020-04-20

ERC Approval Date

0000-00-00

Target Sample Size (Philippines)

Unspecified

Actual Sample Size (Philippines)

Unspecified

Reason for the difference between Target & Actual Sample Sizes

Unspecified

Date of First Enrolment

2020-04-23

Key Inclusion and Exlusion Criteria (CT)

Eligibility: consenting adults (age ≥18) hospitalised with definite COVID-19, not already receiving any of the study drugs, without known allergy or contra-indications to any of them (in the view of the physician responsible for their care), and without anticipated transfer within 72 hours to a non-study hospital. Patients invited to join the study will be those who are admitted to a collaborating hospital; no wider recruitment efforts are expected.

A patient is not eligible for the trial if believed by their physician to have a significant contra- indication to any one of the study drugs (eg, serious chronic liver or heart disease or pregnancy)

Study Type

Interventional

Intervention Name

Remdesivir, Chloroquine/Hydroxychloroquine, Lopinavir (given with Ritonavir) and Interferon (β1a)

Intervention Description

Four potential anti-viral agents, Remdesivir, Chloroquine/Hydroxychloroquine, Lopinavir (given with Ritonavir, to slow hepatic degradation) and Interferon (β1a) are to be evaluated

Amendment Approval Date/Reasons

Date	Amendment Classification	Reason
2020-05-07	Amendments related to the trial arrangements	Change of the trial site or addition of new site

Method of Allocation

Randomized

Masking / Blinding

Open Label

Masking Details

Unspecified

Assignment

Single

Purpose

The aim of this core protocol is to compare the effects on major outcomes in hospital of the local standard of care alone versus the local standard of care plus one of four alternative anti-viral agents.

The primary objective of this large international randomised trial is to provide reliable estimates on any effects of these anti-viral treatments on in-hospital mortality in moderate and in severe COVID.

The secondary objectives are to assess any effects of these anti-viral treatments on hospital duration and receipt of ventilation or intensive care, and to identify any serious adverse reactions.

Phase

Phase II/III

Research Utilization

Utilization	Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others