Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04439071
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
PTC Therapeutics

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.

Condition or disease Intervention/treatment Phase
Pneumonia COVID-19 Coronavirus Drug: PTC299 Other: SOC Drug: Placebo Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of PTC299 in Hospitalized Subjects With COVID-19 (FITE19)
Actual Study Start Date : July 9, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

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.

Drug: PTC299
Oral tablets
Other Name: Emvododstat

Other: SOC
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.

Other: SOC
As defined per local written policies or guidelines.

Drug: Placebo
Oral tablets




Primary Outcome Measures :
  1. Time from Randomization to Respiratory Improvement [ Time Frame: up to Day 28 ]
    Respiratory improvement is defined as sustained peripheral oxygen saturation (SpO2) ≥94% on room air.


Secondary Outcome Measures :
  1. Percentage of Participants Requiring Invasive Ventilation [ Time Frame: up to Day 28 ]
  2. Percentage 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 ]
  3. 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 ]
  4. Time from Randomization to Respiratory Rate ≤ 24 Breaths per Minute on Room Air [ Time Frame: up to Day 28 ]
  5. Time from Randomization to Cough Reported as Mild or Absent [ Time Frame: up to Day 28 ]
    Cough will be rated on a scale of severe, moderate, mild, absent, in those with cough at enrollment rated severe or moderate.

  6. Time from Randomization to Dyspnea Reported as Mild or Absent [ Time Frame: up to Day 28 ]
    Dyspnea will be rated on a scale of severe, moderate, mild, absent, in those with dyspnea at enrollment rated as severe or moderate.

  7. Reduction of Immune Responses [ Time Frame: up to Day 28 ]
  8. Reduction in Viral Load [ Time Frame: up to Day 28 ]
  9. Duration of Hospitalization [ Time Frame: up to Day 28 ]
  10. Number of Mortalities [ Time Frame: Day 28 ]
  11. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: up to Day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04439071


Contacts
Layout table for location contacts
Contact: Patient Advocacy 1-866-562-4620 medinfo@ptcbio.com

Locations
Show Show 33 study locations
Sponsors and Collaborators
PTC Therapeutics
Investigators
Layout table for investigator information
Study Director: Quintus Ngumah, OD, PhD PTC Therapeutics
Layout table for additonal information
Responsible Party: PTC Therapeutics
ClinicalTrials.gov Identifier: NCT04439071    
Other Study ID Numbers: PTC299-VIR-015-COV19
2020-001872-13 ( EudraCT Number )
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases