Covid19Phase 3NCT04629703
Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
A Phase 3 study testing Fostamatinib in people with Covid19 and SARS (Severe Acute Respiratory Syndrome), run by Rigel Pharmaceuticals at 47 sites in 4 countries.
Trial summary
The study is a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19, SARS (Severe Acute Respiratory Syndrome), SARS Pneumonia
- What is being tested?
- Fostamatinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 47 sitesin 4 countries
- Study dates
- 25 Mar 2021to 5 Sep 2022
- Phase
- Phase 3
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age at screening.
- The subject or a legally authorized representative has provided written informed consent.
- Hospitalized COVID-19 subjects without respiratory failure who are either not receiving any oxygen therapy or are receiving supplemental oxygen via mask or nasal prongs.
- Male or non-pregnant, non-lactating female subjects with SARS-CoV-2 infection documented by a hospital approved diagnostic test (eg, a Food and Drug Administration authorized test in the US) within 7 days prior to randomization.
Who cannot join
- Pregnant or lactating female of childbearing potential.
- Use of extracorporeal membrane oxygenation (ECMO).
- Uncontrolled hypertension (systolic blood pressure [BP] ≥160 mmHg and/or diastolic BP ≥100 mmHg), unstable angina, congestive heart failure of New York Heart Association classification III or IV, serious cardiac arrhythmia requiring treatment at screening.
- History of myocardial infarction within 1 month prior to screening.
Trial locations and contacts
47 sites in 4 countries.
47 sites in 4 countries
Argentina13 sites
Hospital de Alta Complejidad Cuenta Alta
Buenos Aires, B1814
Hospital Del Bicentenario - Dr. Luis Federico Leloir
Buenos Aires, B1842
Clinica Zabala
Buenos Aires, C1426
Clinica Adventista Belgrano
Buenos Aires
Clinica Monte Grande
Buenos Aires
Hospital de Infecciosas Dr.Francisco Javier Muñiz
Buenos Aires
Sanatorio Guemes
Buenos Aires
Sanatorio Sagrado Corazon
Buenos Aires
Clinica Chutro
Córdoba, CP, EPU5000
Hospital San Roque
Córdoba
Sanatorio Mayo Privado
Córdoba
Hospital Lencinas
Godoy Cruz, Mendoza Province, PC: 5547
Corporacion Medica de General San Martin
San Martín, Buenos Aires, CP 1650
Brazil13 sites
Hospital Alemão Oswaldo Cruz (HAOC)
Bela Vista, São Paulo, 01323
Hospital Luxenburgo-Associação Mário Penna
Belo Horizonte, Minas Gerais, 30380
Complexo de Prevenção, Diagnóstico, Terapia e Reabilitação Respiratória LTDA
Blumenau, Santa Catarina, 89030
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, São Paulo, 12916-542
Hosp. Angelina Caron
Campina Grande do Sul, Paraná, 83430-000
Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP)
Campinas, São Paulo, 13060
Hospital das Clínicas da Universidade Federal de Goiás (HC/UFG)
Goiânia, Goiás, 74605
Hospital Bandeirantes (LeForte)
Liberdade, São Paulo, 01506
Hospital Universitario de Maringa
Maringá, Paraná, 87083
Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA
Porto Alegre, Rio Grande do Sul, 90020
Hospital des clinicas de porto alegre - Centro de pequisas clinicas
Porto Alegre, Rio Grande do Sul, 90035 - 903
Fundação Faculdade Reg. de Med de SJRP
São José do Rio Preto, São Paulo, 15090
Clinica de Alergia Martti Antila S/S Ltda
Sorocaba, São Paulo, 18040
Mexico12 sites
Hospital Cardiologica Aguascalientes
Aguascalientes
Icaro Investigaciones en Medicina
Chihuahua City, CP:3100
Nuevo Hospital Civil de Guadalajara
Guadalajara
Köhler & Milstein Research
Mérida, Yucatán, 97070
Centro Medico Issemym Toluca
Metepec
Hospital Ángeles Roma
México
The American British Cowdray Medical Center I.A.P.
Mexico City
Unidad Medica para la Salud Integral (UMSI)
Monterrey, Nuevo León
Star Medica Vivo Bicentenario
Nezahualcóyotl, State of Mexico, 57205
CEPREP Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas
Nuevo León
Hospital Civil de Culiacan
Sinaloa, 80230
Hospital Civil de Culiacan
Sinaloa
United States9 sites
Harvard Medical School- Bringham and Women's Hospital
Boston, Massachusetts, 02115
Henry Ford
Detroit, Michigan, 48202
Alternative Research Associates, LLC
Hialeah, Florida, 33012
Houston Methodist Research Institute
Houston, Texas, 77030
Loyola University Medical School
Maywood, Illinois, 60600
Alternative Research Associates, LLC
Miami, Florida, 33143
University of California Irvine
Orange, California, 92868
Ascension Medical Group- St. John Clinic Infectious Disease
Tulsa, Oklahoma, 74101
George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
The study is a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.
Read the detailed description
The primary objective of this study is:
To evaluate the efficacy of fostamatinib when used in combination with standard of care (SOC) in subjects hospitalized with COVID- 19 and requiring oxygen supplementation, as measured by days on oxygen.
- Conditions
- Covid19, SARS (Severe Acute Respiratory Syndrome), SARS Pneumonia, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, Pneumonia, Pneumonia, Viral
- Being tested
- Fostamatinib, Placebo
- Keywords
- COVID19, SARS-Associated Coronavirus Pneumonia, Pneumonia, Viral
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Pneumonia, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FostamatinibDrug
Also called Fostamatinib disodium
Fostamatinib (150 mg twice daily) for 14 days and Standard of Care
PlaceboDrug
Placebo (twice daily) for 14 days and Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Fostamatinib (150 mg twice daily for 14 days) + Standard of Care | Active comparator | Fostamatinib (150 mg twice daily for 14 days) + Standard of Care Receives: Drug: Fostamatinib |
| Placebo (twice daily for 14 days) + Standard of Care | Placebo comparator | Placebo (twice daily for 14 days) + Standard of Care Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days on oxygen from randomization on Day 1 to Day 29
Number of days on oxygen from randomization on Day 1 to Day 29
Measured: 29 days
Secondary outcomes (7)
Mean change from baseline over time in clinical status score using the 8-point ordinal scale, to the average from Day 5 through Day 15.
Mean change from baseline over time in clinical status score using the 8-point ordinal
Measured: 10 days
Number of days in the ICU from randomization on Day 1 to Day 29
Number of days in the ICU from randomization on Day 1 to Day 29
Measured: 29 days
Time to first sustained hospital discharge by Day 29. (A discharge is defined as sustained when no readmission occurs by Day 29 after the discharge).
Time to first sustained hospital discharge by Day 29. (A discharge is defined as sustained when no readmission occurs by Day 29 after the discharge).
Measured: 29 days
All-cause mortality by Day 29.
All-cause mortality by Day 29.
Measured: 29 days
All-cause mortality by Day 60
All-cause mortality by Day 60
Measured: 60 days
Proportion of subjects alive by Day 29 and oxygen free on Day 29.
Proportion of subjects alive by Day 29 and oxygen free on Day 29.
Measured: 29 days
Proportion of subjects alive by Day 60 and oxygen free on Day 29
Proportion of subjects alive by Day 60 and oxygen free on Day 29
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start25 Mar 2021
- Primary completion5 Sep 2022
- Study completion5 Sep 2022
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rigel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629703
- Sponsor's protocol ID
- C-935788-061
- Status last verified
- Aug 2023
- First submitted
- 13 Nov 2020
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
- ClinicalTrials.gov ID
- NCT04629703
- Acronym / sponsor ID
- C-935788-061
- Conditions
- Covid19, SARS (Severe Acute Respiratory Syndrome), SARS Pneumonia, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, Pneumonia, Pneumonia, Viral
- Keywords
- COVID19, SARS-Associated Coronavirus Pneumonia, Pneumonia, Viral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 16 Nov 2020 (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.
The study is a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.
Detailed description
The primary objective of this study is:
To evaluate the efficacy of fostamatinib when used in combination with standard of care (SOC) in subjects hospitalized with COVID- 19 and requiring oxygen supplementation, as measured by days on oxygen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fostamatinib (150 mg twice daily for 14 days) + Standard of Care | Active comparator | Drug: FostamatinibFostamatinib (150 mg twice daily for 14 days) + Standard of Care |
| Placebo (twice daily for 14 days) + Standard of Care | Placebo comparator | Drug: PlaceboPlacebo (twice daily for 14 days) + Standard of Care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age at screening.
- The subject or a legally authorized representative has provided written informed consent.
- Hospitalized COVID-19 subjects without respiratory failure who are either not receiving any oxygen therapy or are receiving supplemental oxygen via mask or nasal prongs.
- Male or non-pregnant, non-lactating female subjects with SARS-CoV-2 infection documented by a hospital approved diagnostic test (eg, a Food and Drug Administration authorized test in the US) within 7 days prior to randomization.
Key exclusion criteria (4 listed)
- Pregnant or lactating female of childbearing potential.
- Use of extracorporeal membrane oxygenation (ECMO).
- Uncontrolled hypertension (systolic blood pressure [BP] ≥160 mmHg and/or diastolic BP ≥100 mmHg), unstable angina, congestive heart failure of New York Heart Association classification III or IV, serious cardiac arrhythmia requiring treatment at screening.
- History of myocardial infarction within 1 month prior to screening.
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 |
|---|---|---|
| FostamatinibAlso: Fostamatinib disodiumFostamatinib (150 mg twice daily) for 14 days and Standard of Care | Drug | Fostamatinib (150 mg twice daily for 14 days) + Standard of Care |
| PlaceboPlacebo (twice daily) for 14 days and Standard of Care | Drug | Placebo (twice daily for 14 days) + Standard of Care |
Primary outcome
Number of days on oxygen from randomization on Day 1 to Day 29
Time frame: 29 days
Number of days on oxygen from randomization on Day 1 to Day 29
7 secondary outcomes
Mean change from baseline over time in clinical status score using the 8-point ordinal scale, to the average from Day 5 through Day 15.
Time frame: 10 days
Number of days in the ICU from randomization on Day 1 to Day 29
Time frame: 29 days
Time to first sustained hospital discharge by Day 29. (A discharge is defined as sustained when no readmission occurs by Day 29 after the discharge).
Time frame: 29 days
All-cause mortality by Day 29.
Time frame: 29 days
All-cause mortality by Day 60
Time frame: 60 days
Proportion of subjects alive by Day 29 and oxygen free on Day 29.
Time frame: 29 days
Proportion of subjects alive by Day 60 and oxygen free on Day 29
Time frame: 60 days
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 18 Aug 2023.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
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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.
47 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fostamatinib in people with Covid19 and SARS (Severe Acute Respiratory Syndrome), run by Rigel Pharmaceuticals at 47 sites in 4 countries.
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 4 inclusion and 4 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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Argentina, Brazil, Mexico, United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of days on oxygen from randomization on Day 1 to Day 29 (time frame: 29 days). 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 NCT04629703, 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 18 Aug 2023.