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

Primary Purpose

Covid19

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Favipiravir

Placebo

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
Subject has access to a smart phone, tablet, or PC
Minimal baseline severity score for COVID-19-related symptoms: at least two symptoms with a score of 2 or higher. COVID-19-related symptoms (excluding changes in the sense of taste or smell) include:
stuffy or runny nose
sore throat
shortness of breath
cough
lack of energy or tiredness
muscle or body aches
headache
chills or shivering
feeling hot or feverish
nausea
diarrhea
vomiting

Exclusion Criteria:

O2 saturation <94%
Shortness of breath at rest
Heart rate ≥ 125 per minute
COVID-19 symptoms first presented >5 days prior to randomization
Requirement for hospitalization at the time of enrollment
Participation in another trial or use of any experimental treatment for COVID-19
Treatment with high steroid dose i.e. >30 mg/day prednisolone equivalent (excluding stable chronic treatment) or remdesivir or anyone receiving SARS-CoV-2 monoclonal antibodies within 3 months prior to enrollment
Known sepsis or organ dysfunction/ failure
Known infection with a respiratory virus other than SARS-CoV2 (e.g. Influenza) or any known bacterial infection (affecting the respiratory system or any other system)
Inability to adhere to study requirements
For premenopausal women: unwilling or unable to use effective birth control measures
Known allergy to favipiravir
Known end-stage kidney disease or requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
Known 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).
Known elevated uric acid levels in the past year or taking uric acid lowering medications (allopurinol, febuxostat)
History of hereditary xanthinuria or history of xanthine urolithiasis.
History of gout or actively being treated for gout.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Favipiravir

Placebo

Arm Description

Favipiravir 200mg tablet

Placebo 200mg tablet

Outcomes

Primary Outcome Measures

Time to sustained clinical recovery

The endpoint will be considered to have been met at the earliest time point at which the subject has reached Sustained Alleviation of Symptoms (Symptoms related to smell or taste are not included in the primary endpoint) reported by the patient have reached a severity of "0 - none" or "1 - mild" in assessments for 4-point scale assessments and not known to have redeveloped any COVID-19 associated signs and symptoms (not including reduced sense of taste or smell) in a severity beyond mild for 4 consecutive days when assessed from the start of study treatment to day 28. To meet the primary endpoint, subjects must survive with no hospitalization to day 28.

Secondary Outcome Measures

Proportion of subjects with COVID-19 progression (narrow progression)

Proportion of subjects with COVID-19 progression, where progression is defined as the occurrence from study day 3 onward of any emergency department (ED) visit for COVID-19 worsening or shortness of breath OR hospitalization for COVID-19 worsening or shortness of breath OR death (narrow progression)

Proportion of subjects with COVID-19 progression (broad progression)

• Proportion of subjects with COVID-19 progression, defined as the occurrence from study day 3 onward of any ED visit for COVID worsening or shortness of breath OR hospitalization for COVID worsening or shortness of breath OR death OR the development of symptomatic worsening from study day 3 onward (defined as >2 additional COVID symptoms at a level of moderate or severe which have not existed on study day 1 or fever (temperature of ≥38.0ºC) which has not existed on study day 1 or oxygen desaturation (O2 saturation <94%) which has not existed on study day 1) (broad progression)

Viral Shedding Sub-Study

Time (number of days) to negative conversion (defined as <100 RNA copies) of detectable SARS-CoV-2 viral RNA (defined as >100 RNA copies) in negative RT-PCR assays of saliva, from start of study treatment to study day 10. Included: all subjects with a positive PCR on study day 1 or 2 or 3. The endpoint will be evaluated from study day 3 onward.

Proportion of subjects showing sustained clinical recovery by study Day 3, 5, 7, 10, 14, 21.

Proportion of subjects showing resolution of Symptoms by Days 3, 5, 7, 10, 14, 21

Proportion of subjects showing resolution of Symptoms by Days 3, 5, 7, 10, 14, 21, where resolution is defined as symptom severity of 0 for all symptoms as well as temperature of <38.0 ºC as well as oxygen saturation of ≥94%.

Proportion of patients showing negative conversion of detectable SARS-CoV-2 viral RNA in saliva

Defined as SARS-CoV-2 viral load conversion from >100 on study day 1 or 2 or 3 to <100 thereafter) on Study Days 3, 5, 7, and 10. Included: all subjects with a positive PCR on study day 1 or 2 or 3.

Proportion of patients showing negative conversion of positive SARS-CoV-2 viral culture in saliva on Study Days 3, 5, 7 and 10

Subjects with a positive saliva SARS-CoV-2 PCR on any study day will have viral cultures performed. Subjects with a positive viral culture on day 1 or 2 or 3 will be included in this analysis.

Proportion of subjects dying from any cause over an assessment period from start of study treatment until Day 28.

Proportion of subject with COVID-19 progression

Proportion of subject with COVID-19 progression, where progression is defined as the occurrence at any point from study day 1 to study day 28 of emergency department (ED) visit for any reason OR hospitalization for any reason.

Full Information

NCT ID

NCT04600895

First Posted

September 15, 2020

Last Updated

November 29, 2021

Sponsor

Appili Therapeutics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04600895

Brief Title

The Prevent Severe COVID-19 (PRESECO) Study

Acronym

PRESECO

Official Title

Favipiravir for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

November 30, 2020 (Actual)

Primary Completion Date

October 20, 2021 (Actual)

Study Completion Date

October 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Appili Therapeutics Inc.

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

Double-blinded, placebo control, randomized, phase-3 clinical trial to evaluate clinical efficacy of Favipiravir in patients with mild to moderate symptoms related to COVID-19 infection

Detailed Description

COVID-19 starts as a pure viral infection and evolves into a multifactorial disease with components of hyper immune activation, end organ damage, and fibrosis. Suppression of viral replication is expected to be impactful early in the course of disease. The ability to mitigate the symptoms at an early stage will prevent progression to severe COVID-19 and can save many lives. Early treatment could also reduce viral shedding, diminishing the period of infectivity and decreasing the number of secondary cases.

6. Conditions and Keywords

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

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1231 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Favipiravir

Arm Type

Experimental

Arm Description

Favipiravir 200mg tablet

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo 200mg tablet

Intervention Type

Drug

Intervention Name(s)

Favipiravir

Intervention Description

Favipiravir

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Time to sustained clinical recovery

Description

Time Frame

From Day 0 to Day 28

Secondary Outcome Measure Information:

Title

Proportion of subjects with COVID-19 progression (narrow progression)

Description

Time Frame

From study day 3 to day 28

Title

Proportion of subjects with COVID-19 progression (broad progression)

Description

Time Frame

From study day 3 to day 28

Title

Viral Shedding Sub-Study

Description

Time Frame

From study day 3 to day 28

Title

Proportion of subjects showing sustained clinical recovery by study Day 3, 5, 7, 10, 14, 21.

Description

Proportion of subjects showing sustained clinical recovery by study Day 3, 5, 7, 10, 14, 21.

Time Frame

Day 3, 5, 7, 10, 14, 21.

Title

Proportion of subjects showing resolution of Symptoms by Days 3, 5, 7, 10, 14, 21

Description

Time Frame

Days 3, 5, 7, 10, 14, 21

Title

Proportion of patients showing negative conversion of detectable SARS-CoV-2 viral RNA in saliva

Description

Defined as SARS-CoV-2 viral load conversion from >100 on study day 1 or 2 or 3 to <100 thereafter) on Study Days 3, 5, 7, and 10. Included: all subjects with a positive PCR on study day 1 or 2 or 3.

Time Frame

Study Days 3, 5, 7, and 10.

Title

Proportion of patients showing negative conversion of positive SARS-CoV-2 viral culture in saliva on Study Days 3, 5, 7 and 10

Description

Subjects with a positive saliva SARS-CoV-2 PCR on any study day will have viral cultures performed. Subjects with a positive viral culture on day 1 or 2 or 3 will be included in this analysis.

Time Frame

Study Days 3, 5, 7 and 10

Title

Proportion of subjects dying from any cause over an assessment period from start of study treatment until Day 28.

Description

Proportion of subjects dying from any cause over an assessment period from start of study treatment until Day 28.

Time Frame

Until day 28

Title

Proportion of subject with COVID-19 progression

Description

Time Frame

Up to day 28

Other Pre-specified Outcome Measures:

Title

Adverse Events: Number (and proportion) of patients reporting treatment emergent adverse events (TEAEs) (by MedDRA system organ class and preferred term).

Description

Number (and proportion) of patients reporting treatment emergent adverse events (TEAEs) (by MedDRA system organ class and preferred term).

Time Frame

Up to day 28

Title

Adverse Events: Number (and proportion) of patients reporting serious treatment emergent adverse events (TEAEs) (by MedDRA system organ class and preferred term).

Description

Number (and proportion) of patients reporting serious treatment emergent adverse events (TEAEs) (by MedDRA system organ class and preferred term).

Time Frame

Up to day 28

Title

Safety Events: Vital Signs

Description

Oral temperature (°C)

Time Frame

Up to day 28

Title

Safety Events: Vital Signs

Description

heart rate (BPM)

Time Frame

Up to day 28

Title

Safety Events: Vital Signs

Description

oxygen saturation (% O2)

Time Frame

Up to day 28

Title