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Trial record 2 of 3 for:    appili

The Prevent Severe COVID-19 (PRESECO) Study (PRESECO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04600895
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Appili Therapeutics Inc.

Brief Summary:
Double-blinded, placebo controlled, randomized, phase 3 trial evaluating the antiviral drug favipiravir as potential therapy for mild to moderate COVID-19 in adult outpatients who are not requiring hospitalization and who have had a recently positive COVID-19 test prior to study enrollment.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Favipiravir Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 826 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Favipiravir for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: Favipiravir Drug: Favipiravir
Favipiravir

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Time to sustained clinical recovery [ Time Frame: From Day 0 to Day 21 ]
    The endpoint will be considered to have been met at the earliest time point at which the associated symptoms over a continuous period of 48 hours.


Secondary Outcome Measures :
  1. Time of Negative Conversion of SARS-CoV2 RNA [ Time Frame: From Day 0 to Day 10 ]
    Time (number of days) to negative conversion of detectable SARS-CoV-2 viral RNA in negative Reverse Transcription-Polymerase Chain Reaction (RT-PCR) assays of saliva

  2. Proportion of Negative Conversion of SARS-CoV2 RNA [ Time Frame: Day 2, 4, 6, 8 and 10 ]
    Proportion of patients showing negative conversion of detectable SARS-CoV-2 viral RNA in saliva

  3. Proportion of patients showing Alleviation of Symptoms [ Time Frame: Day 4, 7, 10, 14 and 21 ]
    Proportion of patients showing Alleviation of Symptoms fever, chills, cough, sore throat, malaise, headache, muscle pain, diarrhea, vomiting, shortness of breath

  4. Proportion of patients that progress to severe COVID-19 [ Time Frame: Day 21 ]
    Progression to severe COVID-19 (severe COVID-19 defined as O2 saturation of <94% at rest, all cause hospitalization, or death)

  5. Reduction in Death Related to COVID-19 [ Time Frame: Day 21 ]
    Proportion of patients dying a. from any cause, b. from a COVID-19 associated complication

  6. Reduction in Patient Hospitalization [ Time Frame: Day 21 ]
    Proportion of patients hospitalized: a. from any cause, b. from a COVID-19 associated complication

  7. Reduction in incidence of hospitalization for respiratory distress or O2 saturation [ Time Frame: Day 21 ]
    Incidence of hospitalization for respiratory distress or O2 saturation <93%


Other Outcome Measures:
  1. Safety / Adverse Events [ Time Frame: Day 21 ]
    Number (and proportion) of patients reporting treatment emergent adverse events by MedDRA system organ class and preferred term

  2. Vitals (Heart rate) [ Time Frame: Day 21 ]
    Changes of parameters for heart rate (beats per minutes) at each assessment during the study/follow-up period, compared to baseline

  3. Vitals (Body Temperature) [ Time Frame: Day 21 ]
    Changes of parameters for body temperature (°C) at each assessment during the study/follow-up period, compared to baseline

  4. Vitals (Oxygen Saturation) [ Time Frame: Day 21 ]
    Changes of parameters for oxygen saturation (%) at each assessment during the study/follow-up period, compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults age 18 or older
  • Tested positive for SARS-CoV-2 by RT-PCR assay using a respiratory tract sample (either nasopharyngeal swab OR oropharyngeal swab OR nasal aspirate OR tracheobronchial aspirate OR saliva) collected within 72 hours of randomization
  • Stated willingness to give their written informed consent to participate in the study
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for 7 days following the last dose of study medication
  • Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
  • Females must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy
  • Females must have a negative pregnancy test at screening
  • Ability to take oral medication and be willing to adhere to the favipiravir/placebo regimen
  • One or more of the following symptoms:

    1. Fever (Temperature ≥ 37.2 °C oral)
    2. Chills
    3. Cough
    4. Shortness of breath or difficulty breathing on exertion
    5. Malaise
    6. Muscle pain
    7. Headache
    8. New loss of taste or smell
    9. Sore throat
    10. Congestion or runny nose
    11. Nausea or vomiting
    12. Diarrhea

Exclusion Criteria:

  • O2 saturation <94%
  • Shortness of breath at rest
  • Heart rate ≥ 125 per minute
  • Requirement for hospitalization at the time of enrolment
  • Participation in another trial or use of any experimental treatment for COVID-19
  • Treatment with high steroid dose (excluding stable chronic treatment) or remdesivir
  • Evidence of sepsis or organ dysfunction/ failure
  • Current hospitalization or requiring hospital admission at screening or enrollment
  • Inability to adhere to study requirements
  • For premenopausal women: unwilling or unable to use effective birth control measures
  • Known allergy to favipiravir
  • Renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) or glomerular filtration rate of less than 20 mL/min.
  • Liver impairment greater than Child-Pugh A
  • Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year).
  • History of elevated uric acid
  • Psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
  • Current use of the following medications, which cannot be discontinued for the duration of the study: pyrazinamide, hydralazine, more than 3000 mg of acetaminophen per day.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04600895


Locations
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United States, Florida
Elixia Clinical Research Collaborative Recruiting
Hollywood, Florida, United States, 33023
Contact: Neil Patel    561-351-7822    npatel@elixiacrc.com   
Sponsors and Collaborators
Appili Therapeutics Inc.
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Responsible Party: Appili Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04600895    
Other Study ID Numbers: ATI0220
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No