Your session is about to expire
← Back to Search
Other
SOC for Coronavirus (FITE19 Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by PTC Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 60
Awards & highlights
FITE19 Trial Summary
This trial is testing if a medication can help treat people who are hospitalized with COVID-19. The trial is double-blind, meaning that neither the participants nor the researchers will know who is receiving the medication or the placebo.
Eligible Conditions
- Coronavirus
- Pneumonia
- Coronavirus Infection
- COVID-19
FITE19 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 60
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time From Randomization to Respiratory Improvement
Secondary outcome measures
Change From Baseline in Cytokine Levels at Day 28
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
+15 moreOther outcome measures
Time From Randomization to Respiratory Improvement Where Symptom Onset Occurred ≤5 Days
Side effects data
From 2017 Phase 3 trial • 339 Patients • NCT0213569242%
Nasopharyngitis
19%
Bronchitis
19%
Upper respiratory tract infection
18%
Sinusitis
17%
Headache
15%
Asthma
12%
Influenza
12%
Back pain
9%
Arthralgia
7%
Oropharyngeal pain
6%
Gastroenteritis
6%
Respiratory tract infection
6%
Cough
5%
Fatigue
5%
Insomnia
5%
Lower respiratory tract infection
5%
Rhinitis
5%
Urinary tract infection
5%
Diarrhoea
4%
Injection site reaction
4%
Eczema
4%
Pruritus
4%
Hypertension
4%
Pharyngitis
4%
Ear infection
4%
Viral upper respiratory tract infection
4%
Dyspnoea
4%
Rash
4%
Pain in extremity
4%
Musculoskeletal pain
4%
Dizziness
4%
Vomiting
4%
Influenza like illness
4%
Nausea
3%
Pneumonia
3%
Myalgia
3%
Gastrooesophageal reflux disease
1%
Foot fracture
1%
Osteonecrosis
1%
Fracture
1%
Hyponatraemia
1%
Nasal polyps
1%
Diverticulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mepolizumab 100 mg SC
FITE19 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PTC299 + Standard of Care (SOC)Experimental Treatment2 Interventions
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.
Group II: Placebo + SOCPlacebo Group2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
PTC299
2007
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
PTC TherapeuticsLead Sponsor
74 Previous Clinical Trials
6,041 Total Patients Enrolled
Quintus Ngumah, OD, PhDStudy DirectorPTC Therapeutics
5 Previous Clinical Trials
518 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger