A Study to Evaluate Efficacy and Safety of PTC299 (Emvododstat) in Hospitalized Participants With Coronavirus (COVID-19) (FITE19)

May 30, 2023 updated by: PTC Therapeutics

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

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.

Study Overview

Status

Terminated

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Westmead, New South Wales, Australia, 02145
        • Westmead Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • St. Albans, Victoria, Australia, 03021
        • Sunshine Hospital
      • Brussels, Belgium, 1000
        • St. Pierre University Hospital
      • Ottignies, Belgium, B-1340
        • Clinique Saint Pierre
    • MG
      • Belo Horizonte, MG, Brazil, 30190-130
        • Hospital Vera Cruz
    • RS
      • Porto Alegre, RS, Brazil, 90035-000
        • Hospital Moinhos de Vento
    • SC
      • Joinville, SC, Brazil, 89204-061
        • Centro Hospitalar Unimed (CHU) - Joinville
    • SP
      • Santos, SP, Brazil, 11045-904
        • Hospital Guilherme Alvaro
      • Sorocaba, SP, Brazil, 18013-000
        • Hospital Santa Casa de Misecórdia de Sorocoba
      • São Paulo, SP, Brazil, 01508-000
        • Hospital Alemao Oswaldo Cruz
      • São Paulo, SP, Brazil, 04023-062
        • Escola Paulista de Medicina (UNIFESP)
      • São Paulo, SP, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
      • Bogotá, Colombia, 110311
        • Fundacion Santa Fe De Bogota
      • Rionegro, Colombia, 054040
        • Centro Cardiovascular Somer Incare
      • Paris, France, 75013
        • Hopital Pitie-Salpetriere
      • Puebla, Mexico, 72410
        • Integra RGH Centro de Investigación/ Hospital MAC Puebla
      • Veracruz, Mexico, 91910
        • SOMECO - Sociedad de Metabolismo y Corazón S.C.
    • Guanajuato
      • Irapuato, Guanajuato, Mexico, 36520
        • Centro Hospitalario MAC
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario Dr. Jose Eleuterio Gonzalez
      • Warsaw, Poland, 02-507
        • Central Clinic Hospital of the MSWiA in Warsaw
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar Universitário de Lisboa Norte (CHULN), E.P.E - Hospital de Santa Maria
      • Santa Maria da Feira, Portugal, 4520-211
        • Centro Hospitalar de Entre o Douro e Vouga, EPE (CHEDV)
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE (CHVNG/E)
      • Benoni, South Africa, 1500
        • Worthwhile Clinical Trials
      • Cape Town, South Africa, 7500
        • TREAD Research
      • Cape Town, South Africa, 7530
        • Tiervlei Trial Centre
      • Durban, South Africa, 4058
        • Ahmed Al-Kadi Private Hospital
      • Pretoria, South Africa, 0001
        • Global Clinical Trials
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
      • San Sebastián de los Reyes, Spain, 28702
        • Hospital Universitario Infanta Sofía
    • California
      • Orange, California, United States, 92868
        • University of California, Irvine
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts Memorial Health Care
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Ralph H. Johnson VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PTC299 + Standard of Care (SOC)

Participants will receive PTC299 at 200 milligrams (mg), administered orally, twice daily (BID) on Days 1 to 7, then at 50 mg administered orally, once daily (QD) on Days 8 to 14.

SOC will also be administered according to local, written policies or guidelines.

Oral tablets
Other Names:
  • Emvododstat
As defined per local written policies or guidelines.
Placebo Comparator: Placebo + SOC

Participants will receive PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.

SOC will also be administered according to local, written policies or guidelines.

As defined per local written policies or guidelines.
Oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time From Randomization to Respiratory Improvement
Time Frame: up to Day 28
Respiratory improvement was defined as sustained peripheral oxygen saturation (SpO2) ≥94% on room air. Median time to respiratory improvement was estimated via the Kaplan-Meier product limit method.
up to Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Hospitalization
Time Frame: up to Day 28
up to Day 28
Number of Participants Requiring Invasive Ventilation
Time Frame: up to Day 28
Number of participants requiring invasive ventilation at any time during the study were reported.
up to Day 28
Number of Participants Requiring Supplemental Oxygen or Non-Invasive Ventilation in Participants Who Did Not Require Supplemental Oxygen at Baseline
Time Frame: up to Day 28
Number of participants requiring supplemental oxygen or non-invasive ventilation at any point during the study in participants who did not require supplemental oxygen at baseline were reported.
up to Day 28
Time From Randomization to Defervescence in Participants Presenting With Fever at Enrollment (Temperature of ≥37.6℃ Axilla, ≥38.0℃ Oral, or ≥38.6°C Tympanic or Rectal)
Time Frame: up to Day 28
Defervescence was defined as body temperature of <37.6° C axilla, <38.0° C oral, or <38.6° C tympanic or rectal without taking any antipyretic treatment and sustained until discharge or Day 28. Median time to defervescence was estimated via the Kaplan-Meier method.
up to Day 28
Time From Randomization to Respiratory Rate ≤ 24 Breaths Per Minute on Room Air
Time Frame: up to Day 28
Median time to respiratory rate in participants who had abnormal respiratory rate at baseline was estimated via the Kaplan-Meier method.
up to Day 28
Time From Randomization to Cough Reported as Mild or Absent
Time Frame: up to Day 28
Cough was rated on a scale of severe, moderate, mild, absent, in those with cough at enrollment rated severe or moderate. Median time to cough reported as mild or absent was estimated via the Kaplan-Meier method.
up to Day 28
Time From Randomization to Dyspnea Reported as Mild or Absent
Time Frame: up to Day 28
Dyspnea was rated on a scale of severe, moderate, mild, absent, in those with dyspnea at enrollment rated as severe or moderate. Median time to dyspnea reported as mild or absent was estimated via the Kaplan-Meier method.
up to Day 28
Change From Baseline in Cytokine Levels at Day 28
Time Frame: Baseline, Day 28
Cytokines included Granulocyte Colony Stimulating factor; Interleukin 10, 17, 2, 6, 7; Macrophage Inflammatory Protein 1 Alpha; Monocyte Chemotactic Protein 1; and Tumor Necrosis Factor.
Baseline, Day 28
Change From Baseline in Level of Acute Phase Protein (C Reactive Protein) at Day 28
Time Frame: Baseline, Day 28
Baseline, Day 28
Change From Baseline in Level of Acute Phase Protein (D-Dimer) at Day 28
Time Frame: Baseline, Day 28
Baseline, Day 28
Change From Baseline in Level of Acute Phase Protein (Ferritin) at Day 28
Time Frame: Baseline, Day 28
Baseline, Day 28
Change From Baseline in Level of Acute Phase Proteins (Troponin I and Troponin T) at Day 28
Time Frame: Baseline, Day 28
Baseline, Day 28
Number of Participants With Normalization of Complete Blood Count (CBC) Who Had CBC Out of Range at Baseline
Time Frame: up to Day 28
Number of participants who returned to normal range CBC were reported. CBC included red blood cell (RBC), hemoglobin (HGB), white blood cell (WBC), and Platelets.
up to Day 28
Change From Baseline in Viral Load at Day 28: SARS-CoV-2 Immunoglobulin A (IgA) Antibody Ratio and SARS-CoV-2 Immunoglobulin G (IgG) Antibody Ratio
Time Frame: Baseline, Day 28
Baseline, Day 28
Change From Baseline in Viral Load at Day 28: SARS-CoV-2 IgM Antibody Absorbance
Time Frame: Baseline, Day 28
Baseline, Day 28
Change From Baseline in Viral Load at Day 28: SARS-CoV2 v2, SARS-CoV2 v2 Nasopharyngeal Swab (NPsw), and Severe Acute Resp Syndrome Coronavirus 2
Time Frame: Baseline, Day 28
Baseline, Day 28
Number of Mortalities at Day 28
Time Frame: Day 28
Mortality was defined as a death event occurring at anytime before the specific date, after the first dose has been received.
Day 28
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: up to Day 60
An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. TEAEs were defined as any AEs that occurred on or after the first study treatment through 30 days after the last dose, or any AEs occurring before the first study treatment but worsening during the treatment through 30 days after the last dose. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
up to Day 60

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time From Randomization to Respiratory Improvement Where Symptom Onset Occurred ≤5 Days
Time Frame: up to Day 28
Respiratory improvement was defined as SpO2 ≥94% on room air. Median time to respiratory improvement was estimated via the Kaplan-Meier product limit method.
up to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Quintus Ngumah, OD, PhD, PTC Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2020

Primary Completion (Actual)

July 20, 2022

Study Completion (Actual)

July 20, 2022

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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