Submitted by: Gloria Nenita Velasco 2020-04-24 11:12:27 Last Updated by: Principe, Jeverly Ann S 2020-05-20 11:09:41


Public health emergency SOLIDARITY TRIAL

PHRR200520-002621

Unspecified

2020-CT0536

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

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.

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

Ongoing

Institution Classification Region LTO #
World Health Organization Private Non-profit NCR
Institution Classification Region LTO #
Department of Health Government NCR
Institution Region
World Health Organization NCR
Department of Science and Technology NCR
National Institutes of Health - University of the Philippines - Manila NCR
Name E-Mail Institution and Institution Address
Madelaine Theresa Casimiro mcasimiro.hpdpb@gmail.com San Lazaro Compound, Rizal Ave. Sta Cruz, Manila 1003
Name E-Mail Institution and Institution Address
Dr. Marissa Alejandria mmalejandria@up.edu.ph UP-PGH Taft Ave, Ermita, Manila, 1000 Metro Manila
Name Expertise Affiliation
Aileen David 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 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

COVID-19

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

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

Recruiting

  • 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

Clinical Trial

Unspecified

20200417110924

2020-04-20

0000-00-00

Unspecified

Unspecified

Unspecified

23 Apr 2020

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)

Interventional

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

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

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

Randomized

Open Label

Unspecified

Single

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 II/III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others

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