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A Study to Evaluate Efficacy and Safety of PTC299 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 : Not yet recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
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

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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)
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine


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: 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 [ 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 ]
  6. Time from Randomization to Dyspnea Reported as Mild or Absent [ Time Frame: up to Day 28 ]
  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 Fatalities [ Time Frame: up to 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.


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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 ≤7 days prior to enrollment.
  • Has oxygen saturation SpO2 <94% on room air.
  • Fever with temperature of ≥36.7 Celsius (℃) axilla, ≥38.0℃ oral, or ≥38.6°C tympanic or rectal.
  • 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 must have a negative pregnancy test at screening and agree to abstinence or the use at least one primary form of contraception for the duration of the study following discharge from the hospital, and for up to 50 days after the last dose of study drug (acceptable methods will be determined by the site).
  • 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 clinical study.
  • Alanine transaminase/aspartate transaminase levels ≥3 times the upper limit of normal (×ULN) or total bilirubin (Tbili) ≥2×ULN.
  • Lymphocyte count <1000 lymphocytes/microliter (μL) or hemoglobin <12.0 grams/deciliter (g/dL) in women or <13.5 g/dL in men.
  • 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, 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
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Contact: Patient Advocacy 1-866-562-4620 medinfo@ptcbio.com

Locations
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United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Spain
Hospital Del Mar
Barcelona, Spain, 08003
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Hospital 12 de Octubre
Madrid, Spain, 28041
Sponsors and Collaborators
PTC Therapeutics
Investigators
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Study Director: Quintus Ngumah, OD, PhD PTC Therapeutics
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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: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
6-(4-fluorophenyl)-2,3-dihydro-5-(4-pyridinyl)imidazo(2,1-b)thiazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action