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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,314

participants targeted

Target at P75+ for not_applicable covid19

Timeline

Completed

Started Apr 2020

Typical duration for not_applicable covid19

Geographic Reach

1 country

25 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12 months study duration

Study Start

First participant enrolled

April 23, 2020

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2021

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2021

Completed

6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed

Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

August 21, 2021

Last Update Submit

February 27, 2022

Conditions

Covid19

Keywords

SolidarityHydroxychloroquineLopinavir+RitonavirInterferon Beta 1aRemdesivir

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

Study Arms (7)

LSoC

NO INTERVENTION

Local Standard of Care

Rem+LSoC

EXPERIMENTAL

Remdesivir with Local Standard of Care

Drug: Remdesivir

HCQ+LSoC

EXPERIMENTAL

Hydroxychloroquine with Local Standard of Care

Drug: Hydroxychloroquine

Lopi/Rito+LSoC

EXPERIMENTAL

Lopinavir/Ritonavir with Local Standard of Care

Drug: Lopinavir / Ritonavir

Lopi/Rito+IFN+LSoC

EXPERIMENTAL

Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care

Drug: Lopinavir / RitonavirDrug: Interferon beta-1a

IFN+LSoC

EXPERIMENTAL

Interferon Beta 1a with Local Standard of Care

Drug: Interferon beta-1a

ACB+LSoC

EXPERIMENTAL

Acalabrutinib with Local Standard of Care

Drug: Acalabrutinib

Interventions

RemdesivirDRUG

Two intravenous loading doses, then daily infusion for 10 days

Rem+LSoC

HydroxychloroquineDRUG

Two oral loading doses, then orally twice daily for 10 days

HCQ+LSoC

Lopinavir / RitonavirDRUG

Orally twice daily for 14 days

Lopi/Rito+IFN+LSoCLopi/Rito+LSoC

Interferon beta-1aDRUG

Daily injection for 6 days

IFN+LSoCLopi/Rito+IFN+LSoC

AcalabrutinibDRUG

Orally twice daily for 10 days

ACB+LSoC

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

Patients with contraindications to any of the study drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of the Philippineslead

Study Sites (25)

Baguio General Hospital

Baguio City, Benguet, Philippines

Location

Cebu Doctor's University Hospital

Cebu City, Cebu, Philippines

Location

Perpetual Succor Hospital Cebu

Cebu City, Cebu, Philippines

Location

Vicente Sotto Memorial Medical Center

Cebu City, Cebu, Philippines

Location

Southern Philippines Medical Center

Davao City, Davao Region, Philippines

Location

West Visayas University Medical Center

Iloilo City, Iloilo, Philippines

Location

St Luke's Medical Center Global

City of Taguig, National Capital Region, Philippines

Location

Makati Medical Center

Makati City, National Capital Region, Philippines

Location

Chinese General Hospital

Manila, National Capital Region, Philippines

Location

Manila Doctors Hospital

Manila, National Capital Region, Philippines

Location

ManilaMed - Medical Center Philippines

Manila, National Capital Region, Philippines

Location

San Lazaro Hospital

Manila, National Capital Region, Philippines

Location

UP - Philippine General Hospital

Manila, National Capital Region, Philippines

Location

Asian Hospital and Medical Center

Muntinlupa, National Capital Region, Philippines

Location

Research Institute for Tropical Medicine

Muntinlupa, National Capital Region, Philippines

Location

San Juan de Dios Educational Foundation Inc - Hospital

Pasay, National Capital Region, Philippines

Location

The Medical City

Pasig, National Capital Region, Philippines

Location

Diliman Doctors Hospital