Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID)

Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID)

ClinicalTrials.gov Identifier: NCT04362137

Novartis Reference Number: CINC424J12301

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 pneumonia.

Condition 
Cytokine Storm (Covid-19)
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
402 participants
Start date 
May 02, 2020
Completion date 
Oct 19, 2020
Gender 
All
Age(s)
12 Years and older (Child, Adult, Older Adult)

Interventions

Drug
Ruxolitinib
Ruxolitinib 5 mg tablets
Drug
Placebo
Matching-image placebo

Eligibility Criteria

Inclusion Criteria:

Patient or guardian/health proxy must provide informed consent (and assent if applicable) before any study assessment is performed.

Male and female patients aged ≥ 12 years (or ≥ the lower age limit allowed by Health Authority and/or Ethics Committee/Institutional Review Board approvals).

Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or another rapid test from the respiratory tract prior to randomization.

Patients currently hospitalized or will be hospitalized prior to randomization.

Patients, who meet at least one of the below criteria:

Pulmonary infiltrates (chest X ray or chest CT scan);
Respiratory frequency ≥ 30/min;
Requiring supplemental oxygen;
Oxygen saturation ≤ 94% on room air;
Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg (1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions (over 1000m).

Exclusion Criteria:

History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.

Presence of severely impaired renal function defined by serum creatinine > 2 mg/dL (>176.8 μmol/L), or have estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation or calculated by the updated bedside Schwartz equation.

Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).

Currently intubated or intubated between screening and randomization. In intensive care unit (ICU) at time of randomization. Intubated or in ICU for COVID-19 disease prior to screening. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).

Unable to ingest tablets at randomization. Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

United States
Novartis Investigative Site
Active, not recruiting
Fullerton, 92835
California
United States
Novartis Investigative Site
Recruiting
Long Beach, 90806
California
United States
Novartis Investigative Site
Completed
Aurora, 80045
Colorado
United States
Novartis Investigative Site
Active, not recruiting
Denver, 80205
Colorado
United States
Novartis Investigative Site
Recruiting
Stamford, 06904
Connecticut
United States
Novartis Investigative Site
Active, not recruiting
Atlanta, 30312
Georgia
United States
Novartis Investigative Site
Active, not recruiting
Idaho Falls, 83404
Idaho
United States
Novartis Investigative Site
Recruiting
Boston, 02115
Massachusetts
United States
Novartis Investigative Site
Withdrawn
Worcester, 01604
Massachusetts
United States
Novartis Investigative Site
Active, not recruiting
Ann Arbor, 48109
Michigan
United States
Novartis Investigative Site
Recruiting
Butte, 59701
Montana
United States
Novartis Investigative Site
Active, not recruiting
Newark, 07103
New Jersey
United States
Novartis Investigative Site
Recruiting
Bronx, 10461
New York
United States
Novartis Investigative Site
Withdrawn
Flushing, 11355
New York
United States
Novartis Investigative Site
Recruiting
New York, 10032
New York
United States
Novartis Investigative Site
Active, not recruiting
Mesquite, 75149
Texas
United States
Novartis Investigative Site
Completed
Seattle, 98104
Washington
United States
Novartis Investigative Site
Completed
Madison, 53705-3611
Wisconsin
United States
Argentina
Novartis Investigative Site
Active, not recruiting
C A B A, CP1405
Buenos Aires
Argentina
Novartis Investigative Site
Active, not recruiting
Buenos Aires, C1426AAM
-
Argentina
Novartis Investigative Site
Active, not recruiting
Buenos Aires, C1430BKC
-
Argentina
Brazil
Novartis Investigative Site
Active, not recruiting
Rio de Janeiro, 22640-000
RJ
Brazil
Novartis Investigative Site
Completed
Blumenau, 89030101
Santa Catarina
Brazil
Novartis Investigative Site
Completed
Barretos, 14784 400
SP
Brazil
Novartis Investigative Site
Active, not recruiting
Sao Paulo, 01327 001
SP
Brazil
Novartis Investigative Site
Completed
Sao Paulo, 04502 001
SP
Brazil
Novartis Investigative Site
Active, not recruiting
Sorocaba,
SP
Brazil
Canada
Novartis Investigative Site
Withdrawn
Montreal, H2X 0A9
Quebec
Canada
Colombia
Novartis Investigative Site
Active, not recruiting
Rionegro, 054047
Antioquia
Colombia
Novartis Investigative Site
Active, not recruiting
Barranquilla, 080005
Atlantico
Colombia
Novartis Investigative Site
Active, not recruiting
Barranquilla,
-
Colombia
France
Novartis Investigative Site
Active, not recruiting
Colombes Cedex, 92701
-
France
Novartis Investigative Site
Active, not recruiting
Eaubonne, 95600
-
France
Novartis Investigative Site
Active, not recruiting
Nantes Cedex 1, 44093
-
France
Novartis Investigative Site
Active, not recruiting
Pessac, 33604
-
France
Novartis Investigative Site
Active, not recruiting
Pierre Benite, 69495
-
France
Germany
Novartis Investigative Site
Withdrawn
Aachen, 52074
-
Germany
Novartis Investigative Site
Withdrawn
Grosshansdorf, 22947
-
Germany
Novartis Investigative Site
Completed
Lubeck, 23538
-
Germany
Novartis Investigative Site
Completed
Muenchen, 81377
-
Germany
Novartis Investigative Site
Active, not recruiting
Nuernberg, 90419
-
Germany
Italy
Novartis Investigative Site
Recruiting
Bologna, 40138
BO
Italy
Novartis Investigative Site
Recruiting
Firenze, 50134
FI
Italy
Novartis Investigative Site
Recruiting
Milano, 20132
MI
Italy
Novartis Investigative Site
Recruiting
Milano, 20162
MI
Italy
Novartis Investigative Site
Recruiting
Rozzano, 20089
MI
Italy
Mexico
Novartis Investigative Site
Active, not recruiting
México, 14050
Distrito Federal
Mexico
Novartis Investigative Site
Active, not recruiting
Ciudad de Mexico, 14080
Mexico CP
Mexico
Novartis Investigative Site
Completed
Estado de Mexico, 52787
-
Mexico
Peru
Novartis Investigative Site
Active, not recruiting
San Isidro, 27
Lima
Peru
Novartis Investigative Site
Active, not recruiting
San Miguel, 32
Lima
Peru
Novartis Investigative Site
Active, not recruiting
Lima, 10
-
Peru
Novartis Investigative Site
Active, not recruiting
Lima, 1
-
Peru
Russian Federation
Novartis Investigative Site
Active, not recruiting
Barnaul, 656045
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Moscow, 111539
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 121309
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Moscow, 123056
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Ryazan, 390039
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
S-Petersburg, 194354
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Saint Petersburg, 194044
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Saint Petersburg, 199106
-
Russian Federation
Novartis Investigative Site
Recruiting
Sestroretsk, 197706
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
St Petersburg, 193312
-
Russian Federation
Spain
Novartis Investigative Site
Active, not recruiting
Salamanca, 37007
Castilla Y Leon
Spain
Novartis Investigative Site
Active, not recruiting
Barcelona, 08035
Cataluna
Spain
Novartis Investigative Site
Active, not recruiting
Badalona, 08916
Catalunya
Spain
Novartis Investigative Site
Active, not recruiting
Madrid, 28031
-
Spain
Novartis Investigative Site
Active, not recruiting
Madrid, 28034
-
Spain
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34098
TUR
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06100
-
Turkey
Novartis Investigative Site
Recruiting
Istanbul,
-
Turkey
Novartis Investigative Site
Active, not recruiting
Yenisehir/Izmir, 35110
-
Turkey
United Kingdom
Novartis Investigative Site
Withdrawn
Blackpool, FY3 8NR
-
United Kingdom
Novartis Investigative Site
Completed
Harrow, HA1 3UJ
-
United Kingdom
Novartis Investigative Site
Active, not recruiting
Leeds, LS9 7TF
-
United Kingdom
Novartis Investigative Site
Completed
London, SE5 9RS
-
United Kingdom
Novartis Investigative Site
Completed
London, WC1E 6HX
-
United Kingdom
Novartis Investigative Site
Completed
Manchester, M13 9PL
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]