PneumoniaPhase 2/3FITE19NCT04439071
A Study to Evaluate Efficacy and Safety of PTC299 (Emvododstat) in Hospitalized Participants With Coronavirus (COVID-19)
A Phase 2/3 study testing PTC299 and SOC in people with Pneumonia and COVID-19, run by PTC Therapeutics at 41 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, COVID-19, Coronavirus
- What is being tested?
- PTC299 and SOC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 41 sitesin 11 countries
- Study dates
- 9 Jul 2020to 20 Jul 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
41 sites in 11 countries.
41 sites in 11 countries
Brazil8 sites
Hospital Vera Cruz
Belo Horizonte, Minas Gerais, 30190-130
Centro Hospitalar Unimed (CHU) - Joinville
Joinville, Santa Catarina, 89204-061
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-000
Hospital Guilherme Alvaro
Santos, São Paulo, 11045-904
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, 01508-000
Escola Paulista de Medicina (UNIFESP)
São Paulo, São Paulo, 04023-062
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São Paulo, São Paulo, 15090-000
Hospital Santa Casa de Misecórdia de Sorocoba
Sorocaba, São Paulo, 18013-000
United States6 sites
Augusta University
Augusta, Georgia, 30912
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
University Hospitals Cleveland
Cleveland, Ohio, 44106
University of California, Irvine
Orange, California, 92868
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, 01605
Spain6 sites
Hospital Del Mar
Barcelona, 08003
Hospital Universitario de Bellvitge
Barcelona, 08907
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, 28702
South Africa5 sites
Worthwhile Clinical Trials
Benoni, 1500
TREAD Research
Cape Town, 7500
Tiervlei Trial Centre
Cape Town, 7530
Ahmed Al-Kadi Private Hospital
Durban, 4058
Global Clinical Trials
Pretoria, 0001
Mexico4 sites
Centro Hospitalario MAC
Irapuato, Guanajuato, 36520
Hospital Universitario Dr. José Eleuterio Gonzalez
Monterrey, Nuevo León, 64460
Integra RGH Centro de Investigación/ Hospital MAC Puebla
Puebla City, 72410
SOMECO - Sociedad de Metabolismo y Corazón S.C.
Veracruz, 91910
Australia3 sites
Monash Medical Centre
Clayton, Victoria, 3168
Sunshine Hospital
St Albans, VC, 03021
Westmead Hospital
Westmead, New South Wales, 02145
Portugal3 sites
Centro Hospitalar Universitário de Lisboa Norte (CHULN), E.P.E - Hospital de Santa Maria
Lisbon, 1649-035
Centro Hospitalar de Entre o Douro e Vouga, EPE (CHEDV)
Santa Maria da Feira, 4520-211
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE (CHVNG/E)
Vila Nova de Gaia, 4434-502
Belgium2 sites
St. Pierre University Hospital
Brussels, 1000
Clinique Saint Pierre
Ottignies, B-1340
Colombia2 sites
Fundación Santa Fe de Bogotá
Bogotá, 110311
Centro Cardiovascular Somer Incare
Rionegro, 054040
About this study
Official title: Evaluation of the Efficacy and Safety of PTC299 in Hospitalized Subjects With COVID-19 (FITE19)
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.
- Conditions
- Pneumonia, COVID-19, Coronavirus
- Being tested
- PTC299, SOC, Placebo
- Medical subject headings
- Pneumonia, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTC299Drug
Also called Emvododstat
Oral tablets
SOCOther
As defined per local written policies or guidelines.
PlaceboDrug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| PTC299 + Standard of Care (SOC) | Experimental | 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. Receives: Drug: PTC299; Other: SOC |
| Placebo + SOC | Placebo comparator | 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. Receives: Other: SOC; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Randomization to Respiratory Improvement
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.
Measured: up to Day 28
Secondary outcomes (18)
Number of Participants Requiring Invasive Ventilation
Number of participants requiring invasive ventilation at any time during the study were reported.
Measured: up to Day 28
Number of Participants Requiring Supplemental Oxygen or Non-Invasive Ventilation in Participants Who Did Not Require Supplemental Oxygen at Baseline
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.
Measured: up to Day 28
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)
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.
Measured: up to Day 28
Time From Randomization to Respiratory Rate ≤ 24 Breaths Per Minute on Room Air
Median time to respiratory rate in participants who had abnormal respiratory rate at baseline was estimated via the Kaplan-Meier method.
Measured: up to Day 28
Time From Randomization to Cough Reported as Mild or Absent
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.
Measured: up to Day 28
Time From Randomization to Dyspnea Reported as Mild or Absent
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.
Measured: up to Day 28
Change From Baseline in Cytokine Levels at Day 28
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.
Measured: Baseline, Day 28
Change From Baseline in Level of Acute Phase Protein (C Reactive Protein) at Day 28
Measured: Baseline, Day 28
Change From Baseline in Level of Acute Phase Protein (D-Dimer) at Day 28
Measured: Baseline, Day 28
Change From Baseline in Level of Acute Phase Protein (Ferritin) at Day 28
Measured: Baseline, Day 28
Change From Baseline in Level of Acute Phase Proteins (Troponin I and Troponin T) at Day 28
Measured: Baseline, Day 28
Number of Participants With Normalization of Complete Blood Count (CBC) Who Had CBC Out of Range at Baseline
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.
Measured: up to Day 28
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
Measured: Baseline, Day 28
Change From Baseline in Viral Load at Day 28: SARS-CoV-2 IgM Antibody Absorbance
Measured: Baseline, Day 28
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
Measured: Baseline, Day 28
Duration of Hospitalization
Measured: up to Day 28
Number of Mortalities at Day 28
Mortality was defined as a death event occurring at anytime before the specific date, after the first dose has been received.
Measured: Day 28
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Measured: up to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start9 Jul 2020
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- PTC Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Quintus Ngumah, OD, PhD, Study director, PTC Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439071
- Sponsor's protocol ID
- PTC299-VIR-015-COV19
- Other IDs
- 2020-001872-13
- Acronym
- FITE19
- Status last verified
- May 2023
- First submitted
- 17 Jun 2020
- Last updated
- 26 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of PTC299 in Hospitalized Subjects With COVID-19 (FITE19)
- ClinicalTrials.gov ID
- NCT04439071
- Acronym / sponsor ID
- FITE19 / PTC299-VIR-015-COV19
- Conditions
- Pneumonia, COVID-19, Coronavirus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 189 participants (actual)
- Lead sponsor
- PTC TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Posted 26 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTC299 + Standard of Care (SOC) | Experimental | Drug: PTC299, Other: SOCParticipants 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 + SOC | Placebo comparator | Other: SOC, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTC299Also: EmvododstatOral tablets | Drug | PTC299 + Standard of Care (SOC) |
| SOCAs defined per local written policies or guidelines. | Other | PTC299 + Standard of Care (SOC), Placebo + SOC |
| PlaceboOral tablets | Drug | Placebo + SOC |
Primary outcome
Time From Randomization to Respiratory Improvement
Time frame: up to Day 28
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.
18 secondary outcomes
Number of Participants Requiring Invasive Ventilation
Time frame: up to Day 28
Number 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
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)
Time frame: up to Day 28
Time From Randomization to Respiratory Rate ≤ 24 Breaths Per Minute on Room Air
Time frame: up to Day 28
Time From Randomization to Cough Reported as Mild or Absent
Time frame: up to Day 28
Time From Randomization to Dyspnea Reported as Mild or Absent
Time frame: up to Day 28
Change From Baseline in Cytokine Levels at Day 28
Time frame: Baseline, Day 28
Change From Baseline in Level of Acute Phase Protein (C Reactive Protein) at Day 28
Time frame: Baseline, Day 28
Change From Baseline in Level of Acute Phase Protein (D-Dimer) at Day 28
Time frame: Baseline, Day 28
Change From Baseline in Level of Acute Phase Protein (Ferritin) at Day 28
Time frame: Baseline, Day 28
Change From Baseline in Level of Acute Phase Proteins (Troponin I and Troponin T) at Day 28
Time frame: Baseline, Day 28
Number of Participants With Normalization of Complete Blood Count (CBC) Who Had CBC Out of Range at Baseline
Time frame: up to Day 28
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
Time frame: Baseline, Day 28
Change From Baseline in Viral Load at Day 28: SARS-CoV-2 IgM Antibody Absorbance
Time frame: Baseline, Day 28
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
Time frame: Baseline, Day 28
Duration of Hospitalization
Time frame: up to Day 28
Number of Mortalities at Day 28
Time frame: Day 28
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: up to Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FINAL REDACTED PROTOCOLLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quintus Ngumah, OD, PhD study director
PTC Therapeutics
41 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PTC299 and SOC in people with Pneumonia and COVID-19, run by PTC Therapeutics at 41 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Brazil, United States, Spain, South Africa, Mexico and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time From Randomization to Respiratory Improvement (time frame: up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.