Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects

Sponsor

Rigel Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04629703

Collaborator

(none)

308

Enrollment

Locations

Arms

19.3

Anticipated Duration (Months)

6.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 SARS (Severe Acute Respiratory Syndrome) SARS Pneumonia SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere Pneumonia Pneumonia, Viral	Drug: Fostamatinib Drug: Placebo	Phase 3

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

Study Type:

Interventional

Anticipated Enrollment :

308 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects

Actual Study Start Date :

Feb 22, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fostamatinib (150 mg twice daily for 14 days) + Standard of Care Fostamatinib (150 mg twice daily for 14 days) + Standard of Care	Drug: Fostamatinib Fostamatinib (150 mg twice daily) for 14 days and Standard of Care Other Names: Fostamatinib disodium
Placebo Comparator: Placebo (twice daily for 14 days) + Standard of Care Placebo (twice daily for 14 days) + Standard of Care	Drug: Placebo Placebo (twice daily) for 14 days and Standard of Care

Arm

Intervention/Treatment

Active Comparator: Fostamatinib (150 mg twice daily for 14 days) + Standard of Care

Fostamatinib (150 mg twice daily for 14 days) + Standard of Care

Drug: Fostamatinib

Fostamatinib (150 mg twice daily) for 14 days and Standard of Care

Other Names:

Fostamatinib disodium

Placebo Comparator: Placebo (twice daily for 14 days) + Standard of Care

Placebo (twice daily for 14 days) + Standard of Care

Drug: Placebo

Placebo (twice daily) for 14 days and Standard of Care

Outcome Measures

Primary Outcome Measures

Number of days on oxygen from randomization on Day 1 to Day 29 [29 days]
Number of days on oxygen from randomization on Day 1 to Day 29

Secondary Outcome Measures

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. [10 days]
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.
Number of days in the ICU from randomization on Day 1 to Day 29 [29 days]
Number of days in the ICU from randomization on Day 1 to Day 29
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). [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).
All-cause mortality by Day 29. [29 days]
All-cause mortality by Day 29.
All-cause mortality by Day 60 [60 days]
All-cause mortality by Day 60
Proportion of subjects alive by Day 29 and oxygen free on Day 29. [29 days]
Proportion of subjects alive by Day 29 and oxygen free on Day 29.
Proportion of subjects alive by Day 60 and oxygen free on Day 29 [60 days]
Proportion of subjects alive by Day 60 and oxygen free on Day 29

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Irvine	Orange	California	United States	92868
2	George Washington University Hospital	Washington	District of Columbia	United States	20037
3	Alternative Research Associates, LLC	Hialeah	Florida	United States	33012
4	Alternative Research Associates, LLC	Miami	Florida	United States	33143
5	Loyola University Medical School	Maywood	Illinois	United States	60600
6	Harvard Medical School- Bringham and Women's Hospital	Boston	Massachusetts	United States	02115
7	Henry Ford	Detroit	Michigan	United States	48202
8	Ascension Medical Group- St. John Clinic Infectious Disease	Tulsa	Oklahoma	United States	74101
9	Houston Methodist Research Institute	Houston	Texas	United States	77030
10	Clinica Chutro	Cordoba	CP	Argentina	EPU5000
11	Hospital Lencinas	Godoy Cruz	Mendoza	Argentina	PC: 5547
12	Corporacion Medica de General San Martin	San Martin	Provincia De Buenos Aires	Argentina	CP 1650
13	Hospital de Alta Complejidad Cuenta Alta	Buenos Aires		Argentina	B1814
14	Hospital Del Bicentenario - Dr. Luis Federico Leloir	Buenos Aires		Argentina	B1842
15	Clinica Zabala	Buenos Aires		Argentina	C1426
16	Clinica Adventista Belgrano	Buenos Aires		Argentina
17	Clinica Monte Grande	Buenos Aires		Argentina
18	Hospital de Infecciosas Dr.Francisco Javier Muñiz	Buenos Aires		Argentina
19	Sanatorio Guemes	Buenos Aires		Argentina
20	Sanatorio Sagrado Corazon	Buenos Aires		Argentina
21	Hospital San Roque	Córdoba		Argentina
22	Sanatorio Mayo Privado	Córdoba		Argentina
23	Hospital das Clínicas da Universidade Federal de Goiás (HC/UFG)	Goiânia	Goiás	Brazil	74605
24	Hospital Luxenburgo-Associação Mário Penna	Belo Horizonte	Minas Gerais	Brazil	30380
25	Hospital Universitario de Maringa	Maringá	Parana	Brazil	87083
26	Hosp. Angelina Caron	Campina Grande do Sul	Paraná	Brazil	83430-000
27	Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA	Porto Alegre	Rio Grande Do Sul	Brazil	90020
28	Hospital des clinicas de porto alegre - Centro de pequisas clinicas	Porto Alegre,	RS	Brazil	90035 - 903
29	Complexo de Prevenção, Diagnóstico, Terapia e Reabilitação Respiratória LTDA	Blumenau	Santa Catarina	Brazil	89030
30	Hospital Alemão Oswaldo Cruz (HAOC)	Bela Vista	Sao Paolo	Brazil	01323
31	Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP)	Campinas	Sao Paolo	Brazil	13060
32	Hospital Bandeirantes (LeForte)	Liberdade	Sao Paolo	Brazil	01506
33	Hospital Universitário São Francisco na Providência de Deus	Braganca Paulista	Sao Paulo	Brazil	12916-542
34	Clinica de Alergia Martti Antila S/S Ltda	Sorocaba	Sao Paulo	Brazil	18040
35	Fundação Faculdade Reg. de Med de SJRP	São José Do Rio Preto	Sao Paulo	Brazil	15090
36	Star Medica Vivo Bicentenario	Nezahualcóyotl	Mex	Mexico	57205
37	Unidad Medica para la Salud Integral (UMSI)	Monterrey	Nuevo Leon	Mexico
38	Köhler & Milstein Research	Mérida	Yucatán	Mexico	97070
39	Hospital Cardiologica Aguascalientes	Aguascalientes		Mexico
40	Icaro Investigaciones en Medicina	Chihuahua		Mexico	CP:3100
41	Nuevo Hospital Civil de Guadalajara	Guadalajara		Mexico
42	Centro Medico Issemym Toluca	Metepec		Mexico
43	The American British Cowdray Medical Center I.A.P.	Mexico City		Mexico
44	Hospital Ángeles Roma	Mexico		Mexico
45	CEPREP Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas	Nuevo León		Mexico
46	Hospital Civil de Culiacan	Sinaloa		Mexico	80230
47	Hospital Civil de Culiacan	Sinaloa		Mexico