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Completed

NCT Number: NCT05024006

Public Health Emergency: SOLIDARITY TRIAL Philippines

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baguio General Hospital, Baguio City, Benguet, Philippines

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remdesivir

Drug

Two intravenous loading doses, then daily infusion for 10 days

Hydroxychloroquine

Drug

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

Lopinavir / Ritonavir

Drug

Orally twice daily for 14 days

Interferon beta-1a

Drug

Daily injection for 6 days

Acalabrutinib

Drug

Orally twice daily for 10 days

Primary outcomes

  1. All-cause mortality

    Time frame: Number of days from hospital admission up to 28 days post discharge

Secondary outcomes

  1. Duration of hospital stay

    Time frame: Number of days from hospital admission to discharge up to 28 days post admission

  2. Time to first receiving ventilation

    Time frame: Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission

Sponsors and collaborators

Lead sponsor

University of the Philippines

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2021
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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