Public Health Emergency: SOLIDARITY TRIAL Philippines

Sponsor

University of the Philippines (Other)

Overall Status

Completed

CT.gov ID

NCT05024006

Collaborator

(none)

1,314

Enrollment

Locations

Arms

11.8

Actual Duration (Months)

52.6

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Remdesivir Drug: Hydroxychloroquine Drug: Lopinavir / Ritonavir Drug: Interferon beta-1a Drug: Acalabrutinib	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1314 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Adaptive designAdaptive design

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 23, 2020

Actual Primary Completion Date :

Apr 17, 2021

Actual Study Completion Date :

Apr 17, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

All-cause mortality [Number of days from hospital admission up to 28 days post discharge]

Secondary Outcome Measures

Duration of hospital stay [Number of days from hospital admission to discharge up to 28 days post admission]
Time to first receiving ventilation [Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Baguio General Hospital	Baguio City	Benguet	Philippines
2	Cebu Doctor's University Hospital	Cebu City	Cebu	Philippines
3	Perpetual Succor Hospital Cebu	Cebu City	Cebu	Philippines
4	Vicente Sotto Memorial Medical Center	Cebu City	Cebu	Philippines
5	Southern Philippines Medical Center	Davao City	Davao	Philippines
6	West Visayas University Medical Center	Iloilo City	Iloilo	Philippines
7	Makati Medical Center	Makati City	Metro Manila	Philippines
8	Chinese General Hospital	Manila	Metro Manila	Philippines
9	Manila Doctors Hospital	Manila	Metro Manila	Philippines
10	ManilaMed - Medical Center Philippines	Manila	Metro Manila	Philippines
11	San Lazaro Hospital	Manila	Metro Manila	Philippines
12	UP - Philippine General Hospital	Manila	Metro Manila	Philippines
13	Asian Hospital and Medical Center	Muntinlupa	Metro Manila	Philippines
14	Research Institute for Tropical Medicine	Muntinlupa	Metro Manila	Philippines
15	San Juan de Dios Educational Foundation Inc - Hospital	Pasay	Metro Manila	Philippines
16	The Medical City	Pasig City	Metro Manila	Philippines
17	Diliman Doctors Hospital	Quezon City	Metro Manila	Philippines
18	Fe Del Mundo Medical Center	Quezon City	Metro Manila	Philippines
19	Lung Center of the Philippines	Quezon City	Metro Manila	Philippines
20	St Luke's Medical Center Quezon City	Quezon City	Metro Manila	Philippines
21	University of the East Ramon Magsaysay Memorial Medical Center	Quezon City	Metro Manila	Philippines
22	World Citi Medical Center	Quezon City	Metro Manila	Philippines
23	Cardinal Santos Medical Center	San Juan	Metro Manila	Philippines
24	St Luke's Medical Center Global	Taguig	Metro Manila	Philippines
25	Batangas Medical Center	Batangas		Philippines