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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04439071
Registration number
NCT04439071
Ethics application status
Date submitted
17/06/2020
Date registered
19/06/2020
Date last updated
26/06/2023
Titles & IDs
Public title
A Study to Evaluate Efficacy and Safety of PTC299 (Emvododstat) in Hospitalized Participants With Coronavirus (COVID-19)
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Scientific title
Evaluation of the Efficacy and Safety of PTC299 in Hospitalized Subjects With COVID-19 (FITE19)
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Secondary ID [1]
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2020-001872-13
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Secondary ID [2]
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PTC299-VIR-015-COV19
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Universal Trial Number (UTN)
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Trial acronym
FITE19
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pneumonia
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COVID-19
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Coronavirus
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PTC299
Other interventions - SOC
Treatment: Drugs - Placebo
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.
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.
Treatment: Drugs: PTC299
Oral tablets
Other interventions: SOC
As defined per local written policies or guidelines.
Treatment: Drugs: Placebo
Oral tablets
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time From Randomization to Respiratory Improvement
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Assessment method [1]
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Respiratory improvement was defined as sustained peripheral oxygen saturation (SpO2) =94% on room air. Median time to respiratory improvement was estimated via the Kaplan-Meier product limit method.
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Timepoint [1]
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up to Day 28
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Secondary outcome [1]
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Number of Participants Requiring Invasive Ventilation
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Assessment method [1]
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Number of participants requiring invasive ventilation at any time during the study were reported.
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Timepoint [1]
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up to Day 28
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Secondary outcome [2]
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Number of Participants Requiring Supplemental Oxygen or Non-Invasive Ventilation in Participants Who Did Not Require Supplemental Oxygen at Baseline
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Assessment method [2]
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Number of participants requiring supplemental oxygen or non-invasive ventilation at any point during the study in participants who did not require supplemental oxygen at baseline were reported.
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Timepoint [2]
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up to Day 28
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Secondary outcome [3]
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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)
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Assessment method [3]
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Defervescence was defined as body temperature of <37.6° C axilla, <38.0° C oral, or <38.6° C tympanic or rectal without taking any antipyretic treatment and sustained until discharge or Day 28. Median time to defervescence was estimated via the Kaplan-Meier method.
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Timepoint [3]
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up to Day 28
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Secondary outcome [4]
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Time From Randomization to Respiratory Rate = 24 Breaths Per Minute on Room Air
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Assessment method [4]
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Median time to respiratory rate in participants who had abnormal respiratory rate at baseline was estimated via the Kaplan-Meier method.
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Timepoint [4]
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up to Day 28
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Secondary outcome [5]
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Time From Randomization to Cough Reported as Mild or Absent
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Assessment method [5]
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Cough was rated on a scale of severe, moderate, mild, absent, in those with cough at enrollment rated severe or moderate. Median time to cough reported as mild or absent was estimated via the Kaplan-Meier method.
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Timepoint [5]
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up to Day 28
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Secondary outcome [6]
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Time From Randomization to Dyspnea Reported as Mild or Absent
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Assessment method [6]
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Dyspnea was rated on a scale of severe, moderate, mild, absent, in those with dyspnea at enrollment rated as severe or moderate. Median time to dyspnea reported as mild or absent was estimated via the Kaplan-Meier method.
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Timepoint [6]
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up to Day 28
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Secondary outcome [7]
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Change From Baseline in Cytokine Levels at Day 28
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Assessment method [7]
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Cytokines included Granulocyte Colony Stimulating factor; Interleukin 10, 17, 2, 6, 7; Macrophage Inflammatory Protein 1 Alpha; Monocyte Chemotactic Protein 1; and Tumor Necrosis Factor.
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Timepoint [7]
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Baseline, Day 28
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Secondary outcome [8]
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Change From Baseline in Level of Acute Phase Protein (C Reactive Protein) at Day 28
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Assessment method [8]
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Timepoint [8]
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Baseline, Day 28
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Secondary outcome [9]
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Change From Baseline in Level of Acute Phase Protein (D-Dimer) at Day 28
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Assessment method [9]
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Timepoint [9]
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Baseline, Day 28
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Secondary outcome [10]
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Change From Baseline in Level of Acute Phase Protein (Ferritin) at Day 28
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Assessment method [10]
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Timepoint [10]
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Baseline, Day 28
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Secondary outcome [11]
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Change From Baseline in Level of Acute Phase Proteins (Troponin I and Troponin T) at Day 28
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Assessment method [11]
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Timepoint [11]
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Baseline, Day 28
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Secondary outcome [12]
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Number of Participants With Normalization of Complete Blood Count (CBC) Who Had CBC Out of Range at Baseline
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Assessment method [12]
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Number of participants who returned to normal range CBC were reported. CBC included red blood cell (RBC), hemoglobin (HGB), white blood cell (WBC), and Platelets.
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Timepoint [12]
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up to Day 28
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Secondary outcome [13]
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Change From Baseline in Viral Load at Day 28: SARS-CoV-2 Immunoglobulin A (IgA) Antibody Ratio and SARS-CoV-2 Immunoglobulin G (IgG) Antibody Ratio
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Assessment method [13]
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Timepoint [13]
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Baseline, Day 28
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Secondary outcome [14]
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Change From Baseline in Viral Load at Day 28: SARS-CoV-2 IgM Antibody Absorbance
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Assessment method [14]
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Timepoint [14]
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Baseline, Day 28
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Secondary outcome [15]
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Change From Baseline in Viral Load at Day 28: SARS-CoV2 v2, SARS-CoV2 v2 Nasopharyngeal Swab (NPsw), and Severe Acute Resp Syndrome Coronavirus 2
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Assessment method [15]
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Timepoint [15]
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Baseline, Day 28
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Secondary outcome [16]
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Duration of Hospitalization
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Assessment method [16]
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Timepoint [16]
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up to Day 28
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Secondary outcome [17]
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Number of Mortalities at Day 28
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Assessment method [17]
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Mortality was defined as a death event occurring at anytime before the specific date, after the first dose has been received.
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Timepoint [17]
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Day 28
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Secondary outcome [18]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [18]
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An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. TEAEs were defined as any AEs that occurred on or after the first study treatment through 30 days after the last dose, or any AEs occurring before the first study treatment but worsening during the treatment through 30 days after the last dose. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
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Timepoint [18]
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up to Day 60
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/07/2022
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Sample size
Target
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Accrual to date
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Final
189
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment hospital [2]
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Monash Medical Centre - Clayton
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Recruitment hospital [3]
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Sunshine Hospital - St. Albans
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Recruitment postcode(s) [1]
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02145 - Westmead
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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03021 - St. Albans
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Georgia
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Country [3]
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United States of America
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State/province [3]
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Maryland
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Country [4]
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United States of America
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State/province [4]
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Massachusetts
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Country [5]
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United States of America
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State/province [5]
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Ohio
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Country [6]
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United States of America
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State/province [6]
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South Carolina
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Country [7]
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Belgium
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State/province [7]
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Brussels
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Country [8]
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Belgium
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State/province [8]
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Ottignies
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Country [9]
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Brazil
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State/province [9]
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MG
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Country [10]
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Brazil
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State/province [10]
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RS
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Country [11]
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Brazil
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State/province [11]
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SC
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Country [12]
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Brazil
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State/province [12]
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SP
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Country [13]
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Colombia
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State/province [13]
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Bogotá
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Country [14]
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Colombia
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State/province [14]
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Rionegro
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Country [15]
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France
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State/province [15]
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Paris
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Country [16]
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Mexico
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State/province [16]
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Guanajuato
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Country [17]
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Mexico
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State/province [17]
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Nuevo León
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Country [18]
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Mexico
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State/province [18]
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Puebla
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Country [19]
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Mexico
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State/province [19]
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Veracruz
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Country [20]
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Poland
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State/province [20]
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Warsaw
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Country [21]
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Portugal
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State/province [21]
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Lisboa
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Country [22]
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Portugal
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State/province [22]
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Santa Maria da Feira
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Country [23]
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Portugal
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State/province [23]
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Vila Nova de Gaia
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Country [24]
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South Africa
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State/province [24]
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Benoni
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Country [25]
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South Africa
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State/province [25]
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Cape Town
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Country [26]
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South Africa
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State/province [26]
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Durban
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Country [27]
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South Africa
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State/province [27]
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Pretoria
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Country [28]
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Spain
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State/province [28]
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Barcelona
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Country [29]
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Spain
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State/province [29]
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Madrid
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Country [30]
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Spain
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State/province [30]
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San Sebastián de los Reyes
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
PTC Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04439071
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Quintus Ngumah, OD, PhD
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Address
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PTC Therapeutics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04439071
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