Clinical trial: Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic Participants (NCT04610138)

Eligibility criteria:
Inclusion Criteria:

          1. Adults, aged 40 - 90 years (inclusive)

          2. Acute onset (within 96 hours of the Baseline visit) of two or more COVID-19 symptoms
             self-rated as moderate-to-severe, including fever, myalgia, fatigue, chest tightness,
             chills, cough, diarrhea, gastrointestinal distress, headache, sore throat, congestion,
             or runny nose, ageusia, anosmia, nausea, tingling or numbness in the extremities, or
             shortness of breath.

          3. Laboratory-confirmed SARS-CoV-2 infection as determined by positive PCR in a sample
             collected ≤ 96 hours prior to the Baseline visit.

          4. PGI-Severity and CGI-Severity assessments of 'Mild', 'Moderate, or 'Severe' at the
             Screening visit (e.g., cannot be 'Normal').

          5. Participant (or legally authorized representatives) provides informed consent prior to
             the initiation of any study procedures.

          6. Participant is willing and able to follow all study procedures and assessments
             according to the study protocol.

          7. Participant is able to consume 60 ml of fluid orally twice daily.

          8. Women of childbearing potential must agree to either abstinence or use at least one
             primary form of contraception, not including hormonal contraception from the time of
             screening through the end of study.

        Exclusion Criteria:

          1. Unable or unwilling to take ZnAg liquid solution or matching placebo as directed.

          2. Hospitalized prior to Baseline for COVID-19 management.

          3. Need for hospitalization and/or ventilatory support at Baseline.

          4. The emergence of any disease during study, other than COVID-19 that could better
             explain the participants' signs and symptoms.

          5. Severe disease: respiratory distress, or requiring supplemental oxygen, or SpO2 ≤ 93%
             on room air, or tachypnea (respiratory rate ≥ 30 breaths/min) at Baseline.

          6. History or presence of serious or acute heart disease such as uncontrolled cardiac
             dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or
             uncontrolled congestive heart failure (NYHA class 3 or 4).

          7. Legal incapacity or limited legal capacity.

          8. Women of childbearing potential who do not agree to use either abstinence or at least
             one primary form of contraception, not including hormonal contraception from the time
             of screening through the end of the study.

          9. Pregnant or breastfeeding.

         10. Participation in another clinical study with an investigational product within the
             prior 12 months (per Resolution 251/1997).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 90 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