Clinical trial: FLARE: Favipiravir +/- Lopinavir: A RCT of Early Antivirals (NCT04499677)

Eligibility criteria:
Inclusion Criteria:

          1. Any adult with the following:

               -  Symptoms compatible with COVID-19 disease (Fever >37.8oC on at least one occasion
                  AND either cough and/ or anosmia) within the first 5 days of symptom onset

               -  OR ANY symptoms compatible with COVID-19 disease (may include, but are not
                  limited to fever, cough, shortness of breath, malaise, myalgia, headache, coryza)
                  and tested positive for SARS-CoV-2 within the first 7 days of symptom onset

               -  OR no symptoms but tested positive for SARS-CoV-2 within the last 48 hours
                  (date/time of test must be within 48 hours of enrolment)

          2. Male or female aged 18 years to 70 years old inclusive at screening

          3. Willing and able to take daily saliva samples

          4. Able to provide full informed consent and willing to comply with trial-related
             procedures

        Exclusion Criteria:

          1. Known hypersensitivity to any of the active ingredients or excipients in favipiravir
             and matched placebo, and in lopinavir/ritonavir and matched placebo

          2. Chronic liver disease at screening (known cirrhosis of any aetiology, chronic
             hepatitis (e.g. autoimmune, viral, steatohepatitis), cholangitis or any known
             elevation of liver aminotransferases with AST or ALT > 3 X ULN)*

          3. Chronic kidney disease (stage 3 or beyond) at screening: eGFR < 60 ml/min/1.73m2*

          4. HIV infection, if untreated, detectable viral load or on protease inhibitor therapy

          5. Any clinical condition which the investigator considers would make the participant
             unsuitable for the trial

          6. Concomitant medications known to interact with favipiravir and matched placebo, and
             with lopinavir/ritonavir and matched placebo, and carry risk of toxicity for the
             participant

          7. Current severe illness requiring hospitalisation

          8. Pregnancy and/ or breastfeeding

          9. Eligible female participants of childbearing potential and male participants with a
             partner of childbearing potential not willing to use highly effective contraceptive
             measures during the trial and within the time point specified following last trial
             treatment dose.

         10. Participants enrolled in any other interventional drug or vaccine trial (co-enrolment
             in observational studies is acceptable).

               -  Considering the importance of early treatment of COVID-19 to impact viral load,
                  the absence of chronic liver/ kidney disease will be confirmed verbally by the
                  participant during pre-screening and Screening/Baseline visit. Safety blood
                  samples will be collected at Screening/Baseline visit (Day 1) and test results
                  will be examined as soon as they become available within 24 hours.
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.
Subject must be at most 70 Years

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