Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Pneumonia COVID-19 Coronavirus Coronavirus Infections 6-(4-fluorophenyl)-2,3-dihydro-5-(4-pyridinyl)imidazo(2,1-b)thiazole PTC299 SOC

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 screening.
  • Has oxygen saturation SpO2 <94% on room air.
  • Fever with temperature of ≥37.6 degrees celsius (℃) axilla, ≥38.0℃ oral, or ≥38.6°C tympanic or rectal. If a participant has received an antipyretic, assessment of fever should occur ≥4 hours after administration of the antipyretic.
  • 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.

You CAN'T join 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 <800 lymphocytes/microliter (μL) or hemoglobin <11 grams/deciliter (g/dL) irrespective of gender.
  • 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.

Locations

  • University of California, Irvine not yet accepting patients
    Orange California 92868 United States
  • Augusta University accepting new patients
    Augusta Georgia 30912 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
PTC Therapeutics
ID
NCT04439071
Phase
Phase 2/3
Study Type
Interventional
Last Updated