A Study to Evaluate Efficacy and Safety of PTC299 (Emvododstat) in Hospitalized Participants With Coronavirus (COVID-19)

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Pneumonia, COVID-19, Coronavirus

In brief

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.

Key facts

Study ID

NCT04439071

Run by

PTC Therapeutics

People needed

189

Starts

2020-07-09

Expected to finish

2022-07-20

Last updated by the study team

2023-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Sunshine Hospital — St Albans, VC, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• St. Pierre University Hospital — Brussels, Belgium
• Clinique Saint Pierre — Ottignies, Belgium
• Hospital Vera Cruz — Belo Horizonte, Minas Gerais, Brazil
• Hospital Moinhos de Vento — Porto Alegre, Rio Grande do Sul, Brazil
• Centro Hospitalar Unimed (CHU) - Joinville — Joinville, Santa Catarina, Brazil
• Hospital Guilherme Alvaro — Santos, São Paulo, Brazil
• Hospital Alemao Oswaldo Cruz — São Paulo, São Paulo, Brazil
• Escola Paulista de Medicina (UNIFESP) — São Paulo, São Paulo, Brazil
• Fundação Faculdade Regional de Medicina de São José do Rio Preto — São Paulo, São Paulo, Brazil
• Hospital Santa Casa de Misecórdia de Sorocoba — Sorocaba, São Paulo, 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 City, Mexico

Full record on ClinicalTrials.gov

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