Clinical trial: Study of Oral Administration of Ribavirin and Nitazoxamide Versus Placebo in COVID-19 (NCT04563208)

Eligibility criteria:
Inclusion Criteria:

          1. Signed a current EC approved informed consent form

          2. Male or female participants between 18 and 75 years of age, inclusive diagnosis of
             SARS-CoV-2 infection, with all of the following, with onset of any within the 48 hours
             prior to testing:

               1. Presence of fever at time of screening of ≥ 38.0°C (≥ 100.0°F)

               2. Presence of at least one constitutional symptom associated with Covid-19 (e.g.
                  headache, myalgia, malaise, or fatigue, rash, diarrhea, loss or alteration of
                  taste/smell) of any severity,

               3. Presence of at least one respiratory symptom (e.g. cough, chest tightness or sore
                  throat)

          3. Diagnosis of COVID-19 with a positive PCR in the past 48 hours

        Exclusion Criteria:

          1. Critically ill with presence of one or more of the following signs:

               1. difficulty breathing or shortness of breath

               2. need for admission to a hospital or an intensive care unit,

               3. acute respiratory failure requiring intubation/mechanical ventilation,

               4. signs of shock including hypotension

               5. Oxygen saturation < 92 %

          2. Any clinically significant screening laboratory results that are greater than 5 times
             the upper limit of normal.

          3. Estimated GFR < 50 mL/min/1.73 m2 (calculated using either Modification of Diet in
             Renal Disease (MDRD) or Cockcroft Gualt

          4. Known genetic hemoglobinopathy (e.g., thalassemia major or sickle cell anemia) or
             autoimmune hemolytic anemia

          5. Hemoglobin less than 10 gm/dL or hematocrit < 30 %

          6. Retinal eye disease

          7. Known chronic kidney disease, stage - 5 or receiving dialysis

          8. Inability to tolerate oral medications

          9. Allergy or prior adverse reaction to either ribavirin or nitazoxanide

         10. QTc interval > 450 mSEC for men and women

         11. History of Torsade de Pointes VT or prior cardiac arrest or congenital long QT
             interval

         12. Current treatment with histamine-2 receptor antagonists (H2 blockers) and/or Protein
             Pump Inhibitors and throughout the study.

         13. Any physical, mental, or social condition, drug/alcohol use, history of illness or
             laboratory abnormality that in the investigator's judgment might interfere with study
             procedures or the ability of the subject to adhere to and complete the study
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 75 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