Clinical trial: The Prevent Severe COVID-19 (PRESECO) Study (NCT04600895)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment