Evaluation of the efficacy and safety of PTC299 in hospitalized subjects with COVID-19 (FITE19)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 380

Inclusion Criteria

1. Subject (or legally authorized representative) is willing and able to provide informed consent and comply with all protocol requirements.
2. Agrees to the collection of nasopharyngeal swabs and venous blood and all other protocol-specified procedures.
3. Male or non-pregnant female adult =18 years of age at time of enrollment.
4. Hospitalized and has laboratory-confirmed infection with SARS-CoV-2.
5. Symptom onset was =14 days prior to Screening
6. Has SpO2 <94% on room air
7. Has at least one of respiratory rate >24 breaths/minute or cough
8. Lung involvement as confirmed by radiographic infiltrates observed on imaging (chest X-ray, CT scan, or an equivalent test)
9. 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:
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- oral
- intravaginal
- transdermal
• progestogen-only hormonal contraception associated with inhibition of ovulation:
- oral
- injectable
- implantable
• intrauterine device
• intrauterine hormone-releasing system
• 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 (eg, bilateral tubal ligation, hysterectomy, bilateral oophorectomy).
10. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 190

Exclusion Criteria

1. Requires mechanical ventilation
2. Current participation in any other interventional study.
3. Severe liver disease as defined by alanine transaminase/aspartate transaminase levels (ALT/AST) >4 times the upper limit of normal.
4. Lymphocyte count <500 lymphocytes/µL or hemoglobin <11.0 g/dL
5. Stage 4 severe chronic kidney disease or requiring dialysis (ie, estimated glomerular filtration rate <30)
6. Any other condition, that in the opinion of the investigator, may be cause to exclude the subject from the study.
7. Use of steroids (except dexamethasone), drugs metabolized by CYP2D6, CYP2C inducers, IL-6 neutralizing antibodies, IL-6 receptor inhibitors, or any investigational therapy.
8. Pregnancy or breast feeding.
9. Anticipated transfer to another hospital which is not a study site within 72 hours.
10. Known allergy to PTC299 or excipients

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the clinical efficacy of PTC299 compared with placebo assessed by time to respiratory improvement in adult subjects hospitalized with COVID-19.;Secondary Objective: • To evaluate the clinical efficacy of PTC299 compared with placebo, as assessed by respiratory function, immune response, length of hospitalization, and mortality.<br>• To evaluate the safety of PTC299 as assessed by drug related adverse events. ;Primary end point(s): The primary endpoint is the time from randomization to respiratory improvement, defined as peripheral oxygen saturation (SpO2) =94% on room air sustained until discharge from the hospital or the end of the study (Day 28).;Timepoint(s) of evaluation of this end point: The primary endpoint is time from randomization to respiratory improvement, defined as SpO2 =94% on room air sustained until discharge from the hospital or the end of the study (Day 28).

Secondary Outcome Measures

Name	Time	Method

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