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

Primary Purpose

Pneumonia, COVID-19, Coronavirus

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

PTC299

SOC

Placebo

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:
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.

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.

Sites / Locations

University of California, Irvine
Augusta University
Johns Hopkins Hospital
University of Massachusetts Memorial Health Care
University Hospitals Cleveland
Ralph H. Johnson VA Medical Center
Westmead Hospital
Monash Medical Centre
Sunshine Hospital
St. Pierre University Hospital
Clinique Saint Pierre
Hospital Vera Cruz
Hospital Moinhos de Vento
Centro Hospitalar Unimed (CHU) - Joinville
Hospital Guilherme Alvaro
Hospital Santa Casa de Misecórdia de Sorocoba
Hospital Alemao Oswaldo Cruz
Escola Paulista de Medicina (UNIFESP)
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Fundación Santa Fe de Bogotá
Centro Cardiovascular Somer Incare
Hôpital Pitié-Salpêtrière
Centro Hospitalario MAC
Hospital Universitario Dr. José Eleuterio Gonzalez
Integra RGH Centro de Investigación/ Hospital MAC Puebla
SOMECO - Sociedad de Metabolismo y Corazón S.C.
Central Clinic Hospital of the MSWiA in Warsaw
Centro Hospitalar Universitário de Lisboa Norte (CHULN), E.P.E - Hospital de Santa Maria
Centro Hospitalar de Entre o Douro e Vouga, EPE (CHEDV)
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE (CHVNG/E)
Worthwhile Clinical Trials
TREAD Research
Tiervlei Trial Centre
Ahmed Al-Kadi Private Hospital
Global Clinical Trials
Hospital Del Mar
Hospital Universitario de Bellvitge
Hospital Universitario Infanta Leonor
Hospital Universitario Ramón y Cajal
Hospital 12 de Octubre
Hospital Universitario Infanta Sofía

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PTC299 + Standard of Care (SOC)

Placebo + SOC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants Requiring Invasive Ventilation

Number of participants requiring invasive ventilation at any time during the study were reported.

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.

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.

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.

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.

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.

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.

Change From Baseline in Level of Acute Phase Protein (C Reactive Protein) at Day 28

Change From Baseline in Level of Acute Phase Protein (D-Dimer) at Day 28

Change From Baseline in Level of Acute Phase Protein (Ferritin) at Day 28

Change From Baseline in Level of Acute Phase Proteins (Troponin I and Troponin T) at 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.

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

Change From Baseline in Viral Load at Day 28: SARS-CoV-2 IgM Antibody Absorbance

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

Duration of Hospitalization

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.

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.

Full Information

NCT ID

NCT04439071

First Posted

June 17, 2020

Last Updated

May 30, 2023

Sponsor

PTC Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04439071

Brief Title

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

Acronym

FITE19

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision

Study Start Date

July 9, 2020 (Actual)

Primary Completion Date

July 20, 2022 (Actual)

Study Completion Date

July 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PTC Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia, COVID-19, Coronavirus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

189 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PTC299 + Standard of Care (SOC)

Arm Type

Experimental

Arm Description

Arm Title

Placebo + SOC

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

PTC299

Other Intervention Name(s)

Emvododstat

Intervention Description

Oral tablets

Intervention Type

Other

Intervention Name(s)

SOC

Intervention Description

As defined per local written policies or guidelines.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral tablets

Primary Outcome Measure Information:

Title

Time From Randomization to Respiratory Improvement

Description

Time Frame

up to Day 28

Secondary Outcome Measure Information:

Title

Number of Participants Requiring Invasive Ventilation

Description

Number of participants requiring invasive ventilation at any time during the study were reported.

Time Frame

up to Day 28

Title

Number of Participants Requiring Supplemental Oxygen or Non-Invasive Ventilation in Participants Who Did Not Require Supplemental Oxygen at Baseline

Description

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.

Time Frame

up to Day 28

Title

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)

Description

Time Frame

up to Day 28

Title

Time From Randomization to Respiratory Rate ≤ 24 Breaths Per Minute on Room Air

Description

Median time to respiratory rate in participants who had abnormal respiratory rate at baseline was estimated via the Kaplan-Meier method.

Time Frame

up to Day 28

Title

Time From Randomization to Cough Reported as Mild or Absent

Description

Time Frame

up to Day 28

Title

Time From Randomization to Dyspnea Reported as Mild or Absent

Description

Time Frame

up to Day 28

Title

Change From Baseline in Cytokine Levels at Day 28

Description

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.

Time Frame

Baseline, Day 28

Title

Change From Baseline in Level of Acute Phase Protein (C Reactive Protein) at Day 28

Time Frame

Baseline, Day 28

Title

Change From Baseline in Level of Acute Phase Protein (D-Dimer) at Day 28

Time Frame

Baseline, Day 28

Title

Change From Baseline in Level of Acute Phase Protein (Ferritin) at Day 28

Time Frame

Baseline, Day 28

Title

Change From Baseline in Level of Acute Phase Proteins (Troponin I and Troponin T) at Day 28

Time Frame

Baseline, Day 28

Title

Number of Participants With Normalization of Complete Blood Count (CBC) Who Had CBC Out of Range at Baseline

Description

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.

Time Frame

up to Day 28

Title

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

Title

Change From Baseline in Viral Load at Day 28: SARS-CoV-2 IgM Antibody Absorbance

Time Frame

Baseline, Day 28

Title

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

Title

Duration of Hospitalization

Time Frame

up to Day 28

Title

Number of Mortalities at Day 28

Description

Mortality was defined as a death event occurring at anytime before the specific date, after the first dose has been received.

Time Frame

Day 28

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

up to Day 60

Other Pre-specified Outcome Measures:

Title

Time From Randomization to Respiratory Improvement Where Symptom Onset Occurred ≤5 Days

Description

Respiratory improvement was defined as SpO2 ≥94% on room air. Median time to respiratory improvement was estimated via the Kaplan-Meier product limit method.

Time Frame

up to Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Quintus Ngumah, OD, PhD

Organizational Affiliation

PTC Therapeutics

Official's Role

Study Director

Facility Information:

Facility Name

University of California, Irvine

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Augusta University

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

University of Massachusetts Memorial Health Care

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

University Hospitals Cleveland

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Ralph H. Johnson VA Medical Center

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29401

Country

United States

Facility Name

Westmead Hospital

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

02145

Country

Australia

Facility Name

Monash Medical Centre

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Sunshine Hospital

City

St. Albans

State/Province

Victoria

ZIP/Postal Code

03021

Country

Australia

Facility Name

St. Pierre University Hospital

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Clinique Saint Pierre

City

Ottignies

ZIP/Postal Code

B-1340

Country

Belgium

Facility Name

Hospital Vera Cruz

City

Belo Horizonte

State/Province

ZIP/Postal Code

30190-130

Country

Brazil

Facility Name

Hospital Moinhos de Vento

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-000

Country

Brazil

Facility Name

Centro Hospitalar Unimed (CHU) - Joinville

City

Joinville

State/Province

ZIP/Postal Code

89204-061

Country

Brazil

Facility Name

Hospital Guilherme Alvaro

City

Santos

State/Province

ZIP/Postal Code

11045-904

Country

Brazil

Facility Name

Hospital Santa Casa de Misecórdia de Sorocoba

City

Sorocaba

State/Province

ZIP/Postal Code

18013-000

Country

Brazil

Facility Name

Hospital Alemao Oswaldo Cruz

City

São Paulo

State/Province

ZIP/Postal Code

01508-000

Country

Brazil

Facility Name

Escola Paulista de Medicina (UNIFESP)

City

São Paulo

State/Province

ZIP/Postal Code

04023-062

Country

Brazil

Facility Name

Fundação Faculdade Regional de Medicina de São José do Rio Preto

City

São Paulo

State/Province

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Fundación Santa Fe de Bogotá

City

Bogotá

ZIP/Postal Code

110311

Country

Colombia

Facility Name

Centro Cardiovascular Somer Incare

City

Rionegro

ZIP/Postal Code

054040

Country

Colombia

Facility Name

Hôpital Pitié-Salpêtrière

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Centro Hospitalario MAC

City

Irapuato

State/Province

Guanajuato

ZIP/Postal Code

36520

Country

Mexico

Facility Name

Hospital Universitario Dr. José Eleuterio Gonzalez

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Integra RGH Centro de Investigación/ Hospital MAC Puebla

City

Puebla

ZIP/Postal Code

72410

Country

Mexico

Facility Name

SOMECO - Sociedad de Metabolismo y Corazón S.C.

City

Veracruz

ZIP/Postal Code

91910

Country

Mexico

Facility Name

Central Clinic Hospital of the MSWiA in Warsaw

City

Warsaw

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Centro Hospitalar Universitário de Lisboa Norte (CHULN), E.P.E - Hospital de Santa Maria

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Centro Hospitalar de Entre o Douro e Vouga, EPE (CHEDV)

City

Santa Maria da Feira

ZIP/Postal Code

4520-211

Country

Portugal

Facility Name

Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE (CHVNG/E)

City

Vila Nova de Gaia

ZIP/Postal Code

4434-502

Country

Portugal

Facility Name

Worthwhile Clinical Trials

City

Benoni

ZIP/Postal Code

1500

Country

South Africa

Facility Name

TREAD Research

City

Cape Town

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Tiervlei Trial Centre

City

Cape Town

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Ahmed Al-Kadi Private Hospital

City

Durban

ZIP/Postal Code

4058

Country

South Africa

Facility Name

Global Clinical Trials

City

Pretoria

ZIP/Postal Code

0001

Country

South Africa

Facility Name

Hospital Del Mar

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Hospital Universitario de Bellvitge

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Universitario Infanta Leonor

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Facility Name

Hospital Universitario Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Hospital 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario Infanta Sofía

City

San Sebastián de los Reyes

ZIP/Postal Code

28702

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217411&parentIdentifier=PTC299-VIR-015-COV19&attachmentIdentifier=642c87e2-eb4d-4a5c-85e5-1df1ccd361ef&fileName=Global_PTC299-VIR-015-COV19_Clinical_Protocol_V7.0_-_02JUN2021_final_redacted.pdf&versionIdentifier=

Description

FINAL REDACTED PROTOCOL

Learn more about this trial

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

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