This study is currently recruiting participants.
Number
001509-I
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 100 Years
Referral Letter Required
No
Population Exclusion(s)
Children;Pregnant Women
Keywords
Clinical Trial; Pneumonia; Protease; Inhibitor; Ensitrelvir
Recruitment Keyword(s)
None
Condition(s)
COVID-19
Investigational Drug(s)
S-217622 (ensitrelvir)
Investigational Device(s)
Intervention(s)
Drug: ensitrelvir Other: placebo
Supporting Site
National Institute of Allergy and Infectious Diseases
Respiratory infections, such as COVID-19 and influenzas, remain a threat to people s health. Most viral respiratory infections are mild, but some can become bad enough that people need to be hospitalized. Complications can be severe and affect many organs. It is likely that the viruses that cause these illnesses will evolve, and more dangerous strains may emerge. Researchers want to find better treatments for respiratory illnesses such as COVID-19.
Objective:
To test a new drug (S-217622) for treatment of people in the hospital with COVID-19.
Eligibility:
People aged 18 years and older who are hospitalized with COVID-19.
Design:
Participants will be screened. They will have a physical exam with blood tests.
The study drug is a pill taken by mouth. Participants will be randomly assigned to receive either the study drug or a placebo. A placebo is a pill that looks just like the real drug but contains no medicine.
Participants will be asked to take their pills for 5 days. They will take 3 pills the first day and 1 pill on each of the next 4 days. Participants who are able to leave the hospital before the 5th day will continue to take the pills at home.
Participants may have blood tests and nasal swab tests for COVID-19 for up to 14 days.
All other tests and treatments will be the usual care for people hospitalized with respiratory illnesses.
Participants will complete a questionnaire about their health after 60 days.
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INCLUSION CRITERIA: 1. Age >=18 years. 2. Informed consent for trial participation. 3. Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection. EXCLUSION CRITERIA: 1. The patient is expected to be discharged from the hospital within the next 24 hours. 2. Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization. 3. Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization. 4. Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life. 5. Expected inability or unwillingness to participate in study procedures. 6. In the opinion of the investigator, participation in a trial is not in the best interest of the patient. For this trial, additional inclusions not outlined in the master protocol include: 1. Confirmation of SARS-CoV-2 infection by nucleic acid test (NAT) or equivalent non-NAT test [list of approved tests is in the PIM] collected within the prior 14 days. 2. Onset of symptoms attributable to SARS-CoV-2 infection occurred within 14 days before randomization. 3. Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection. For this trial, additional exclusions not outlined in the master protocol include: 1. Allergy to investigational agent or vehicle 2. Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622 3. Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure. 4. Known estimated glomerular filtration rate (eGRF) <30 mL/min/1.73m2 5. Continuous renal replacement therapy or chronic dialysis 6. Current pregnancy 7. Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent. 8. Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through 30 days from the last dose of the investigational agent. 9. Men who are unwilling to abstain from sexual intercourse with women of child- bearing potential or to use barrier contraception through 30 days from the last dose of the investigational agent. 10.Inability to take investigational agent in tablet form by mouth. NOTE: the exclusion criteria (#10) for patients unable to take the oral formulation of S- 217622 (or placebo) may be removed if stability testing supports enteral administration of crushed tablets. If available data supports enteral administration of S-217622 (or placebo), then exclusion #10 would be removed and patients unable to take oral tablets would be eligible; e.g., those on invasive mechanical ventilation or ECMO.
1. Age >=18 years.
2. Informed consent for trial participation.
3. Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection.
EXCLUSION CRITERIA:
1. The patient is expected to be discharged from the hospital within the next 24 hours.
2. Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization.
3. Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization.
4. Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life.
5. Expected inability or unwillingness to participate in study procedures.
6. In the opinion of the investigator, participation in a trial is not in the best interest of the patient.
For this trial, additional inclusions not outlined in the master protocol include:
1. Confirmation of SARS-CoV-2 infection by nucleic acid test (NAT) or equivalent non-NAT test [list of approved tests is in the PIM] collected within the prior 14 days.
2. Onset of symptoms attributable to SARS-CoV-2 infection occurred within 14 days before randomization.
3. Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection.
For this trial, additional exclusions not outlined in the master protocol include:
1. Allergy to investigational agent or vehicle
2. Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622
3. Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure.
4. Known estimated glomerular filtration rate (eGRF) <30 mL/min/1.73m2
5. Continuous renal replacement therapy or chronic dialysis
6. Current pregnancy
7. Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent.
8. Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through 30 days from the last dose of the investigational agent.
9. Men who are unwilling to abstain from sexual intercourse with women of child- bearing potential or to use barrier contraception through 30 days from the last dose of the investigational agent.
10.Inability to take investigational agent in tablet form by mouth.
NOTE: the exclusion criteria (#10) for patients unable to take the oral formulation of S- 217622 (or placebo) may be removed if stability testing supports enteral administration of crushed tablets. If available data supports enteral administration of S-217622 (or placebo), then exclusion #10 would be removed and patients unable to take oral tablets
would be eligible; e.g., those on invasive mechanical ventilation or ECMO.
Principal Investigator
Referral Contact
For more information: