Public Health Emergency: SOLIDARITY TRIAL Philippines

NCT ID: NCT05024006

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-23

Study Completion Date

2021-04-17

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.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Adaptive design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LSoC

Local Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Rem+LSoC

Remdesivir with Local Standard of Care

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

Two intravenous loading doses, then daily infusion for 10 days

HCQ+LSoC

Hydroxychloroquine with Local Standard of Care

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

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

Lopi/Rito+LSoC

Lopinavir/Ritonavir with Local Standard of Care

Group Type EXPERIMENTAL

Lopinavir / Ritonavir

Intervention Type DRUG

Orally twice daily for 14 days

Lopi/Rito+IFN+LSoC

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

Group Type EXPERIMENTAL

Lopinavir / Ritonavir

Intervention Type DRUG

Orally twice daily for 14 days

Interferon beta-1a

Intervention Type DRUG

Daily injection for 6 days

IFN+LSoC

Interferon Beta 1a with Local Standard of Care

Group Type EXPERIMENTAL

Interferon beta-1a

Intervention Type DRUG

Daily injection for 6 days

ACB+LSoC

Acalabrutinib with Local Standard of Care

Group Type EXPERIMENTAL

Acalabrutinib

Intervention Type DRUG

Orally twice daily for 10 days

Interventions

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Remdesivir

Two intravenous loading doses, then daily infusion for 10 days

Intervention Type DRUG

Hydroxychloroquine

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

Intervention Type DRUG

Lopinavir / Ritonavir

Orally twice daily for 14 days

Intervention Type DRUG

Interferon beta-1a

Daily injection for 6 days

Intervention Type DRUG

Acalabrutinib

Orally twice daily for 10 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of the Philippines

OTHER

Sponsor Role lead

Responsible Party

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Marissa Alejandria MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baguio General Hospital

Baguio City, Benguet, Philippines

Site Status

Cebu Doctor's University Hospital

Cebu City, Cebu, Philippines

Site Status

Perpetual Succor Hospital Cebu

Cebu City, Cebu, Philippines

Site Status

Vicente Sotto Memorial Medical Center

Cebu City, Cebu, Philippines

Site Status

Southern Philippines Medical Center

Davao City, Davao Region, Philippines

Site Status

West Visayas University Medical Center

Iloilo City, Iloilo, Philippines

Site Status

St Luke's Medical Center Global

City of Taguig, National Capital Region, Philippines

Site Status

Makati Medical Center

Makati City, National Capital Region, Philippines

Site Status

Chinese General Hospital

Manila, National Capital Region, Philippines

Site Status

Manila Doctors Hospital

Manila, National Capital Region, Philippines

Site Status

ManilaMed - Medical Center Philippines

Manila, National Capital Region, Philippines

Site Status

San Lazaro Hospital

Manila, National Capital Region, Philippines

Site Status

UP - Philippine General Hospital

Manila, National Capital Region, Philippines

Site Status

Asian Hospital and Medical Center

Muntinlupa, National Capital Region, Philippines

Site Status

Research Institute for Tropical Medicine

Muntinlupa, National Capital Region, Philippines

Site Status

San Juan de Dios Educational Foundation Inc - Hospital

Pasay, National Capital Region, Philippines

Site Status

The Medical City

Pasig, National Capital Region, Philippines

Site Status

Diliman Doctors Hospital

Quezon City, National Capital Region, Philippines

Site Status

Fe Del Mundo Medical Center

Quezon City, National Capital Region, Philippines

Site Status

Lung Center of the Philippines

Quezon City, National Capital Region, Philippines

Site Status

St Luke's Medical Center Quezon City

Quezon City, National Capital Region, Philippines

Site Status

University of the East Ramon Magsaysay Memorial Medical Center

Quezon City, National Capital Region, Philippines

Site Status

World Citi Medical Center

Quezon City, National Capital Region, Philippines

Site Status

Cardinal Santos Medical Center

San Juan City, National Capital Region, Philippines

Site Status

Batangas Medical Center

Batangas, , Philippines

Site Status

Countries

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Philippines

References

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Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.

Reference Type DERIVED
PMID: 36695483 (View on PubMed)

Other Identifiers

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SJREB-2020-20

Identifier Type: -

Identifier Source: org_study_id

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