Covid19NCT05024006
Public Health Emergency: SOLIDARITY TRIAL Philippines
A study testing Remdesivir, Hydroxychloroquine and Lopinavir / Ritonavir in people with Covid19, run by University of the Philippines at 25 sites in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Remdesivir, Hydroxychloroquine and Lopinavir / Ritonavir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,314 participants
- Where
- 25 sitesPhilippines
- Study dates
- 23 Apr 2020to 17 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with contraindications to any of the study drugs.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Philippines25 sites
Baguio General Hospital
Baguio City, Benguet
Batangas Medical Center
Batangas
Cebu Doctor's University Hospital
Cebu City, Cebu
Perpetual Succor Hospital Cebu
Cebu City, Cebu
Vicente Sotto Memorial Medical Center
Cebu City, Cebu
St Luke's Medical Center Global
City of Taguig, National Capital Region
Southern Philippines Medical Center
Davao City, Davao Region
West Visayas University Medical Center
Iloilo City, Iloilo
Makati Medical Center
Makati City, National Capital Region
Chinese General Hospital
Manila, National Capital Region
Manila Doctors Hospital
Manila, National Capital Region
ManilaMed - Medical Center Philippines
Manila, National Capital Region
San Lazaro Hospital
Manila, National Capital Region
UP - Philippine General Hospital
Manila, National Capital Region
Asian Hospital and Medical Center
Muntinlupa, National Capital Region
Research Institute for Tropical Medicine
Muntinlupa, National Capital Region
San Juan de Dios Educational Foundation Inc - Hospital
Pasay, National Capital Region
The Medical City
Pasig, National Capital Region
Diliman Doctors Hospital
Quezon City, National Capital Region
Fe Del Mundo Medical Center
Quezon City, National Capital Region
Lung Center of the Philippines
Quezon City, National Capital Region
St Luke's Medical Center Quezon City
Quezon City, National Capital Region
University of the East Ramon Magsaysay Memorial Medical Center
Quezon City, National Capital Region
World Citi Medical Center
Quezon City, National Capital Region
Cardinal Santos Medical Center
San Juan City, National Capital Region
About this study
Official title: An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care 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.
- Conditions
- Covid19
- Being tested
- Remdesivir, Hydroxychloroquine, Lopinavir / Ritonavir, Interferon beta-1a, Acalabrutinib
- Keywords
- Solidarity, Hydroxychloroquine, Lopinavir+Ritonavir, Interferon Beta 1a, Remdesivir
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemdesivirDrug
Two intravenous loading doses, then daily infusion for 10 days
Two oral loading doses, then orally twice daily for 10 days
Lopinavir / RitonavirDrug
Orally twice daily for 14 days
Interferon beta-1aDrug
Daily injection for 6 days
AcalabrutinibDrug
Orally twice daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| LSoC | No intervention | Local Standard of Care |
| Rem+LSoC | Experimental | Remdesivir with Local Standard of Care Receives: Drug: Remdesivir |
| HCQ+LSoC | Experimental | Hydroxychloroquine with Local Standard of Care Receives: Drug: Hydroxychloroquine |
| Lopi/Rito+LSoC | Experimental | Lopinavir/Ritonavir with Local Standard of Care Receives: Drug: Lopinavir / Ritonavir |
| Lopi/Rito+IFN+LSoC | Experimental | Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care Receives: Drug: Lopinavir / Ritonavir; Drug: Interferon beta-1a |
| IFN+LSoC | Experimental | Interferon Beta 1a with Local Standard of Care Receives: Drug: Interferon beta-1a |
| ACB+LSoC | Experimental | Acalabrutinib with Local Standard of Care Receives: Drug: Acalabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: Number of days from hospital admission up to 28 days post discharge
Secondary outcomes (2)
Duration of hospital stay
Measured: Number of days from hospital admission to discharge up to 28 days post admission
Time to first receiving ventilation
Measured: Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start23 Apr 2020
- Primary completion17 Apr 2021
- Study completion17 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adaptive design
- Masking
- None (open label)
- Enrolment
- 1,314 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marissa Alejandria MD, University of the Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024006
- Sponsor's protocol ID
- SJREB-2020-20
- Status last verified
- Feb 2022
- First submitted
- 21 Aug 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36695483
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care Philippines
- ClinicalTrials.gov ID
- NCT05024006
- Acronym / sponsor ID
- SJREB-2020-20
- Conditions
- Covid19
- Keywords
- Solidarity, Hydroxychloroquine, Lopinavir+Ritonavir, Interferon Beta 1a, Remdesivir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,314 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 17 Apr 2021 (actual)
- Study completion
- 17 Apr 2021 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Adaptive design
| Arm | Type | Receives |
|---|---|---|
| LSoC | No intervention | –Local Standard of Care |
| Rem+LSoC | Experimental | Drug: RemdesivirRemdesivir with Local Standard of Care |
| HCQ+LSoC | Experimental | Drug: HydroxychloroquineHydroxychloroquine with Local Standard of Care |
| Lopi/Rito+LSoC | Experimental | Drug: Lopinavir / RitonavirLopinavir/Ritonavir with Local Standard of Care |
| Lopi/Rito+IFN+LSoC | Experimental | Drug: Lopinavir / Ritonavir, Drug: Interferon beta-1aLopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care |
| IFN+LSoC | Experimental | Drug: Interferon beta-1aInterferon Beta 1a with Local Standard of Care |
| ACB+LSoC | Experimental | Drug: AcalabrutinibAcalabrutinib with Local Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consenting adults (age ≥18) hospitalised with the following criteria will be included in the study:
Key exclusion criteria (1 listed)
- Patients with contraindications to any of the study drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemdesivirTwo intravenous loading doses, then daily infusion for 10 days | Drug | Rem+LSoC |
| HydroxychloroquineTwo oral loading doses, then orally twice daily for 10 days | Drug | HCQ+LSoC |
| Lopinavir / RitonavirOrally twice daily for 14 days | Drug | Lopi/Rito+IFN+LSoC, Lopi/Rito+LSoC |
| Interferon beta-1aDaily injection for 6 days | Drug | IFN+LSoC, Lopi/Rito+IFN+LSoC |
| AcalabrutinibOrally twice daily for 10 days | Drug | ACB+LSoC |
Primary outcome
All-cause mortality
Time frame: Number of days from hospital admission up to 28 days post discharge
2 secondary outcomes
Duration of hospital stay
Time frame: Number of days from hospital admission to discharge up to 28 days post admission
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 36695483Grundeis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remdesivir, Hydroxychloroquine and Lopinavir / Ritonavir in people with Covid19, run by University of the Philippines at 25 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Number of days from hospital admission up to 28 days post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05024006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.