Public Health Emergency: SOLIDARITY TRIAL Philippines

Study Overview
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Brief Summary
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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.

Official Title
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An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care Philippines

Conditions
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Covid19

Intervention / Treatment
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* Drug: Remdesivir
* Drug: Hydroxychloroquine
* Drug: Lopinavir / Ritonavir
* Drug: Interferon beta-1a
* Drug: Acalabrutinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Adaptive design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: LSoC<br>Local Standard of Care | |
| Experimental: Rem+LSoC<br>Remdesivir with Local Standard of Care | Drug: Remdesivir<br>* Two intravenous loading doses, then daily infusion for 10 days<br>|
| Experimental: HCQ+LSoC<br>Hydroxychloroquine with Local Standard of Care | Drug: Hydroxychloroquine<br>* Two oral loading doses, then orally twice daily for 10 days<br>|
| Experimental: Lopi/Rito+LSoC<br>Lopinavir/Ritonavir with Local Standard of Care | Drug: Lopinavir / Ritonavir<br>* Orally twice daily for 14 days<br>|
| Experimental: Lopi/Rito+IFN+LSoC<br>Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care | Drug: Lopinavir / Ritonavir<br>* Orally twice daily for 14 days<br>Drug: Interferon beta-1a<br>* Daily injection for 6 days<br>|
| Experimental: IFN+LSoC<br>Interferon Beta 1a with Local Standard of Care | Drug: Interferon beta-1a<br>* Daily injection for 6 days<br>|
| Experimental: ACB+LSoC<br>Acalabrutinib with Local Standard of Care | Drug: Acalabrutinib<br>* Orally twice daily for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | Number of days from hospital admission up to 28 days post discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solidarity, Hydroxychloroquine, Lopinavir+Ritonavir, Interferon Beta 1a, Remdesivir