An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care Philippines
Overview
- Phase
- Not Applicable
- Intervention
- Acalabrutinib
- Conditions
- Covid19
- Sponsor
- University of the Philippines
- Enrollment
- 1314
- Locations
- 25
- Primary Endpoint
- All-cause mortality
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Marissa Alejandria MD
Professor
University of the Philippines
Eligibility Criteria
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.
Arms & Interventions
ACB+LSoC
Acalabrutinib with Local Standard of Care
Intervention: Acalabrutinib
IFN+LSoC
Interferon Beta 1a with Local Standard of Care
Intervention: Interferon beta-1a
Rem+LSoC
Remdesivir with Local Standard of Care
Intervention: Remdesivir
HCQ+LSoC
Hydroxychloroquine with Local Standard of Care
Intervention: Hydroxychloroquine
Lopi/Rito+LSoC
Lopinavir/Ritonavir with Local Standard of Care
Intervention: Lopinavir / Ritonavir
Lopi/Rito+IFN+LSoC
Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care
Intervention: Lopinavir / Ritonavir
Lopi/Rito+IFN+LSoC
Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care
Intervention: Interferon beta-1a
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: Number of days from hospital admission up to 28 days post discharge
Secondary Outcomes
- Time to first receiving ventilation(Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission)
- Duration of hospital stay(Number of days from hospital admission to discharge up to 28 days post admission)