Public Health Emergency: SOLIDARITY TRIAL Philippines

University of the Philippines

Status: Completed

Conditions: Covid19

Treatments: Drug: Lopinavir / Ritonavir; Drug: Acalabrutinib; Drug: Remdesivir; Drug: Hydroxychloroquine; Drug: Interferon beta-1a

Study type: Interventional

Funder types: Other

Identifiers

NCT05024006

SJREB-2020-20

Details and patient eligibility

About

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.

Enrollment: 1,314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,314 participants in 7 patient groups

LSoC

No Intervention group

Description:

Local Standard of Care

Rem+LSoC

Experimental group

Description:

Remdesivir with Local Standard of Care

Treatment:

Drug: Remdesivir

HCQ+LSoC

Experimental group

Description:

Hydroxychloroquine with Local Standard of Care

Treatment:

Drug: Hydroxychloroquine

Lopi/Rito+LSoC

Experimental group

Description:

Lopinavir/Ritonavir with Local Standard of Care

Treatment:

Drug: Lopinavir / Ritonavir

Lopi/Rito+IFN+LSoC

Experimental group

Description:

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

Treatment:

Drug: Interferon beta-1a

Drug: Lopinavir / Ritonavir

IFN+LSoC

Experimental group

Description:

Interferon Beta 1a with Local Standard of Care

Treatment:

Drug: Interferon beta-1a

ACB+LSoC

Experimental group

Description:

Acalabrutinib with Local Standard of Care

Treatment:

Drug: Acalabrutinib