Clinical trial: Effect of a Combination of Treatment of Reginmune Capsule and Immunofree Tablets in the Treatment of Mild to Moderate COVID-19 Patients (NCT04494204)

Eligibility criteria:
Inclusion Criteria:

          -  Gender: Either male or non-pregnant, non-lactating female aged > 18-70

          -  Patients with RT-PCR confirmed diagnosis of COVID-19

          -  Patients with mild to moderate COVID-19 infection having either one of the following
             criteria: oPaO2/FiO2:200-300 OR Respiratory rate ? 24/min and SaO2/SpO2 > 90% on room
             air

          -  Subjects willing to give written informed consent

          -  Subjects able to take the drug orally and comply with the study protocol

          -  Women of child bearing potential must have a negative urine pregnancy test prior to
             study entry

        Exclusion Criteria:

          -  Patients with persistent vomiting

          -  Critically ill patients

          -  P/F ratio less than 200 (moderate-severe ARDS)

          -  Shock (Requiring Vasopressor to maintain a MAP more than 65 mm of hg or MAP below 65)

          -  Patients with known active hepatitis, tuberculosis and definite bacterial or fungal
             infections

          -  Patients with altered mental state

          -  Patients with multiple organ failure requiring ICU monitoring and treatment

          -  Patients with respiratory failure and requiring mechanical ventilation

          -  Patients with any concurrent medical condition or uncontrolled, clinically significant
             systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia
             etc.) that, in the opinion of investigator precludes the subject's participation in
             the study or interferes with the interpretation of the study results.

          -  Patients with history of serology tests positive for hepatitis B, hepatitis C, or
             human immunodeficiency virus.

          -  Patients who have received specific antiviral drugs ritonavir/lopinavir, or
             chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week
             before admission

          -  Patient who have participated in another investigational study within 3 months prior
             to enrollment in this study

          -  Investigators, study personnel, sponsor's representatives and their first-degree
             relatives.

          -  Pregnant subjects
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