FITE19: A Study to Evaluate Efficacy and Safety of PTC299 (Emvododstat) in Hospitalized Participants With Coronavirus (COVID-19)

Sponsor

PTC Therapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04439071

Collaborator

(none)

380

Enrollment

Locations

Arms

23.7

Anticipated Duration (Months)

9.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia COVID-19 Coronavirus	Drug: PTC299 Other: SOC Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 9, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: PTC299 Oral tablets Other Names: Emvododstat Other: SOC As defined per 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.	Other: SOC As defined per local written policies or guidelines. Drug: Placebo Oral tablets

Arm

Intervention/Treatment

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.

Drug: PTC299

Oral tablets

Other Names:

Emvododstat

Other: SOC

As defined per 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.

Other: SOC

As defined per local written policies or guidelines.

Drug: Placebo

Oral tablets

Outcome Measures

Primary Outcome Measures

Time from Randomization to Respiratory Improvement [up to Day 28]
Respiratory improvement is defined as sustained peripheral oxygen saturation (SpO2) ≥94% on room air.

Secondary Outcome Measures

Percentage of Participants Requiring Invasive Ventilation [up to Day 28]
Percentage of Participants Requiring Supplemental Oxygen or Non-Invasive Ventilation in Participants who did not Require Supplemental Oxygen at Baseline [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) [up to Day 28]
Time from Randomization to Respiratory Rate ≤ 24 Breaths per Minute on Room Air [up to Day 28]
Time from Randomization to Cough Reported as Mild or Absent [up to Day 28]
Cough will be rated on a scale of severe, moderate, mild, absent, in those with cough at enrollment rated severe or moderate.
Time from Randomization to Dyspnea Reported as Mild or Absent [up to Day 28]
Dyspnea will be rated on a scale of severe, moderate, mild, absent, in those with dyspnea at enrollment rated as severe or moderate.
Reduction of Immune Responses [up to Day 28]
Reduction in Viral Load [up to Day 28]
Duration of Hospitalization [up to Day 28]
Number of Mortalities [Day 28]
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [up to Day 28]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine	Orange	California	United States	92868
2	Augusta University	Augusta	Georgia	United States	30912
3	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
4	University of Massachusetts Memorial Health Care	Worcester	Massachusetts	United States	01605
5	University Hospitals Cleveland	Cleveland	Ohio	United States	44106
6	Ralph H. Johnson VA Medical Center	Charleston	South Carolina	United States	29401
7	Westmead Hospital	Westmead	New South Wales	Australia	02145
8	Monash Medical Centre	Clayton	Victoria	Australia	3168
9	Sunshine Hospital	St. Albans	Victoria	Australia	03021
10	St. Pierre University Hospital	Brussels		Belgium	1000
11	Clinique Saint Pierre	Ottignies		Belgium	B-1340
12	Hospital Vera Cruz	Belo Horizonte	MG	Brazil	30190-130
13	Hospital Moinhos de Vento	Porto Alegre	RS	Brazil	90035-000
14	Centro Hospitalar Unimed (CHU) - Joinville	Joinville	SC	Brazil	89204-061
15	Hospital Guilherme Alvaro	Santos	SP	Brazil	11045-904
16	Hospital Santa Casa de Misecórdia de Sorocoba	Sorocaba	SP	Brazil	18013-000
17	Hospital Alemao Oswaldo Cruz	São Paulo	SP	Brazil	01508-000
18	Escola Paulista de Medicina (UNIFESP)	São Paulo	SP	Brazil	04023-062
19	Fundação Faculdade Regional de Medicina de São José do Rio Preto	São Paulo	SP	Brazil	15090-000
20	Fundación Santa Fe de Bogotá	Bogotá		Colombia	110311
21	Centro Cardiovascular Somer Incare	Rionegro		Colombia	054040
22	Hôpital Pitié-Salpêtrière	Paris		France	75013
23	Centro Hospitalario MAC	Irapuato	Guanajuato	Mexico	36520
24	Hospital Universitario Dr. José Eleuterio Gonzalez	Monterrey	Nuevo León	Mexico	64460
25	Integra RGH Centro de Investigación/ Hospital MAC Puebla	Puebla		Mexico	72410
26	SOMECO - Sociedad de Metabolismo y Corazón S.C.	Veracruz		Mexico	91910
27	Central Clinic Hospital of the MSWiA in Warsaw	Warsaw		Poland	02-507
28	Centro Hospitalar Universitário de Lisboa Norte (CHULN), E.P.E - Hospital de Santa Maria	Lisboa		Portugal	1649-035
29	Centro Hospitalar de Entre o Douro e Vouga, EPE (CHEDV)	Santa Maria da Feira		Portugal	4520-211
30	Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE (CHVNG/E)	Vila Nova de Gaia		Portugal	4434-502
31	Worthwhile Clinical Trials	Benoni		South Africa	1500
32	TREAD Research	Cape Town		South Africa	7500
33	Tiervlei Trial Centre	Cape Town		South Africa	7530
34	Ahmed Al-Kadi Private Hospital	Durban		South Africa	4058
35	Global Clinical Trials	Pretoria		South Africa	0001
36	Hospital Del Mar	Barcelona		Spain	08003
37	Hospital Universitario de Bellvitge	Barcelona		Spain	08907
38	Hospital Universitario Infanta Leonor	Madrid		Spain	28031
39	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
40	Hospital 12 de Octubre	Madrid		Spain	28041
41	Hospital Universitario Infanta Sofía	San Sebastián de los Reyes		Spain	28702

Sponsors and Collaborators

PTC Therapeutics

Investigators

Study Director: Quintus Ngumah, OD, PhD, PTC Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PTC Therapeutics

ClinicalTrials.gov Identifier:

NCT04439071

Other Study ID Numbers:

PTC299-VIR-015-COV19
2020-001872-13

First Posted:

Jun 19, 2020

Last Update Posted:

Jun 24, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Coronavirus Infections

Study Results

No Results Posted as of Jun 24, 2022