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

  • STATUS
    Recruiting
  • participants needed
    380
  • sponsor
    PTC Therapeutics
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Updated on 16 February 2024
See if I qualify
ct scan
fever
vasectomy
x-rays
oxygen saturation
cough
oximetry
covid-19
chest x-ray
SARS
coronavirus infection
acute respiratory syndrome (sars)

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.

Details
Condition Pulmonary Disease, Upper respiratory infection, Pneumonia, Pneumonia, Coronavirus, Covid 19
Age 18years - 100years
Treatment Placebo, PTC299, SOC
Clinical Study IdentifierNCT04439071
SponsorPTC Therapeutics
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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 38.6C 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) 2ULN
Lymphocyte count <1000 lymphocytes/microliter (L) 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
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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ct scan
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