The Prevent Severe COVID-19 (PRESECO) Study

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Appili Therapeutics Inc.
• Treatments: Favipiravir

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

• 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

• 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

• 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)

• 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.