Official Title
Evaluation of the Efficacy and Safety of PTC299 in Hospitalized Subjects With COVID-19 (FITE19)
Brief Summary

This is a randomized, double-blind, placebo-controlled, multicenter, 28-day study of adult participants hospitalized with COVID-19, with a safety follow-up telephone call at Day 60.

Terminated
Pneumonia
COVID-19
Coronavirus

Drug: PTC299

Oral tablets
Other Name: Emvododstat

Other: SOC

As defined per local written policies or guidelines.

Drug: Placebo

Oral tablets

Eligibility Criteria

Inclusion Criteria:

- Signed and dated informed consent document(s).

- Agrees to the collection of nasopharyngeal swabs and venous blood and all other
protocol-specified procedures.

- Male or non-pregnant female adult ≥18 years of age at time of enrollment.

- Hospitalized and has laboratory-confirmed infection with severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2).

- Symptom onset was ≤10 days prior to screening.

- Has oxygen saturation SpO2 <94% on room air.

- Has at least one of a respiratory rate >24 breaths/minute or cough.

- Lung involvement as confirmed by radiographic infiltrates observed on imaging (chest
X-ray, computed tomography (CT) scan, or an equivalent test).

- Women of childbearing potential (as defined in [CTFG 2014]) must have a negative
pregnancy test at screening and agree to abstinence or the use at least one of the
following highly effective forms of contraception (with a failure rate of <1% per year
when used consistently and correctly). Contraception or abstinence must be continued
for the duration of the study following discharge from the hospital, and for up to 50
days after the last dose of study drug:

i) combined (estrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation: oral, intravaginal, and transdermal ii) progestogen-only
hormonal contraception associated with inhibition of ovulation: oral, injectable, and
implantable iii) intrauterine device iv) intrauterine hormone-releasing system v)
vasectomized partner with confirmed azoospermia All females will be considered of
childbearing potential unless they are postmenopausal (at least 12 months consecutive
amenorrhea in the appropriate age group without other known or suspected cause) or
have been sterilized surgically (for example, bilateral tubal ligation, hysterectomy,
bilateral oophorectomy).

- Men sexually active with women of childbearing potential who have not had a vasectomy
must agree to use a barrier method of birth control during the study following
discharge from the hospital and for up to 50 days after the last dose of study drug.

Exclusion Criteria:

- Requires mechanical ventilation.

- Current participation in any other interventional study.

- Alanine transaminase/aspartate transaminase levels ≥3 times the upper limit of normal
(×ULN) or total bilirubin (Tbili) ≥2×ULN.

- Lymphocyte count <500 lymphocytes/microliter (μL) or hemoglobin <11 grams/deciliter
(g/dL).

- Stage 4 severe chronic kidney disease or requiring dialysis (that is, estimated
glomerular filtration rate <30).

- Any other condition, that in the opinion of the Investigator, may be cause to exclude
the participant from the study.

- Use of steroids (except dexamethasone), sensitive CYP2D6 substrates, CYP2C inducers,
IL-6 neutralizing antibodies, IL-6 receptor inhibitors, or any investigational
therapy.

- Pregnancy or breast feeding.

- Anticipated transfer to another hospital which is not a study site within 72 hours.

- Known allergy to PTC299 or excipients.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Australia
Belgium
Brazil
Colombia
France
Mexico
Poland
Portugal
South Africa
Spain
United States
Locations

University of California, Irvine
Orange, California, United States

Augusta University
Augusta, Georgia, United States

Johns Hopkins Hospital
Baltimore, Maryland, United States

University of Massachusetts Memorial Health Care
Worcester, Massachusetts, United States

University Hospitals Cleveland
Cleveland, Ohio, United States

Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States

Westmead Hospital
Westmead, New South Wales, Australia

Monash Medical Centre
Clayton, Victoria, Australia

Sunshine Hospital
St. Albans, Victoria, Australia

St. Pierre University Hospital
Brussels, Belgium

Clinique Saint Pierre
Ottignies, Belgium

Hospital Vera Cruz
Belo Horizonte, MG, Brazil

Hospital Moinhos de Vento
Porto Alegre, RS, Brazil

Centro Hospitalar Unimed (CHU) - Joinville
Joinville, SC, Brazil

Hospital Guilherme Alvaro
Santos, SP, Brazil

Hospital Santa Casa de Misecórdia de Sorocoba
Sorocaba, SP, Brazil

Hospital Alemao Oswaldo Cruz
São Paulo, SP, Brazil

Escola Paulista de Medicina (UNIFESP)
São Paulo, SP, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto
São Paulo, SP, Brazil

Fundación Santa Fe de Bogotá
Bogotá, Colombia

Centro Cardiovascular Somer Incare
Rionegro, Colombia

Hôpital Pitié-Salpêtrière
Paris, France

Centro Hospitalario MAC
Irapuato, Guanajuato, Mexico

Hospital Universitario Dr. José Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico

Integra RGH Centro de Investigación/ Hospital MAC Puebla
Puebla, Mexico

SOMECO - Sociedad de Metabolismo y Corazón S.C.
Veracruz, Mexico

Central Clinic Hospital of the MSWiA in Warsaw
Warsaw, Poland

Centro Hospitalar Universitário de Lisboa Norte (CHULN), E.P.E - Hospital de Santa Maria
Lisboa, Portugal

Centro Hospitalar de Entre o Douro e Vouga, EPE (CHEDV)
Santa Maria da Feira, Portugal

Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE (CHVNG/E)
Vila Nova de Gaia, Portugal

Worthwhile Clinical Trials
Benoni, South Africa

TREAD Research
Cape Town, South Africa

Tiervlei Trial Centre
Cape Town, South Africa

Ahmed Al-Kadi Private Hospital
Durban, South Africa

Global Clinical Trials
Pretoria, South Africa

Hospital Del Mar
Barcelona, Spain

Hospital Universitario de Bellvitge
Barcelona, Spain

Hospital Universitario Infanta Leonor
Madrid, Spain

Hospital Universitario Ramón y Cajal
Madrid, Spain

Hospital 12 de Octubre
Madrid, Spain

Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Spain

Quintus Ngumah, OD, PhD, Study Director
PTC Therapeutics

PTC Therapeutics
NCT Number
MeSH Terms
COVID-19
Coronavirus Infections