Clinical trial: Study to Evaluate Efficacy and Safety of "VIRACIDE" IN THE MANAGEMENT OF CORONA VIRUS DISEASE 2019 (COVID-19) (NCT04596085)

Eligibility criteria:
Inclusion Criteria:

          1. 50 years or older

          2. Both male and female subjects will be included

          3. Positive oropharyngeal/nasal swab RT-PCR for Sars-Co- V2. Diagnosed not more than 2
             days ago(diagnosis

             ≤2days).

          4. Either asymptomatic or have mild symptoms. Onset of symptoms within no more than 4
             days If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever
             38.50С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal
             highly sensitive C-reactive protein (HS-CRP) (<10mg/L). There are no signs of
             dehydration, sepsis or shortness of breath.

          5. Chronic stable medical conditions: diabetes mellitus, or hypertension, or chronic
             heart disease. Under treatment and controlled by medication

          6. Signed informed consent/or consent given through text message, WhatsApp ore-mail.

          7. Ability to understand the requirements of the Research Protocol and follow the
             research procedures.

          8. Subject should be willing to be managed in isolation wards

          9. Negative pregnancy test (for female participants)

         10. Adequate contraception for study duration

        Exclusion Criteria:

          1. Less than 50years

          2. With severe COVID-19 symptoms requiring immediate hospitalization

          3. Investigator considers the subject unsuitable for ViraCide

          4. History of symptoms of more than 4days

          5. COVID-19 diagnosed >2 days ago using oropharyngeal/nasal swab RT-PCR forSars-Co-V2

          6. History of cardiopulmonary resuscitation

          7. Subjects having history of organ failure or conditions requiring ICU monitoring and
             treatment, such as severe liver disease, severe renal dysfunction, upper
             gastrointestinal hemorrhage, disseminated intravascular coagulation or any other
             condition that in the PI"s opinion makes the subject unfit to participate

          8. Respiratory failure, ARDS or need of mechanical ventilation

          9. History of acute exacerbation of comorbidity like heart failure, diabetic
             ketoacidosis, myocardial infection, major cardiac rhythm disorder or any other
             condition that in the PI"s opinion makes the subject unfit to participate

         10. History of or current hepatic failure or severely compromised liver function, or renal
             failure or having chronic kidney disease or acute renal failure

         11. History of or currently receiving treatment for an endocrine disorder like
             hypothyroidism, hyperthyroidism that is likely to affect the basal heart rate.

         12. History of or currently under treatment for asthma [exception: patients with history
             of asthma, not on medications/inhalers/nebulizers for at least 6 months before study
             start), COPD, bronchiectasis, asbestosis and other such chronic lung conditions that
             can compromise SpO2 and RR.

         13. HIV, HBsAg, HCV positive

         14. Any condition causing immunodeficiency

         15. Systemic connective tissue disease or any autoimmune disease that is likely to affect
             HS-CRP levels

         16. History of epilepsy/epileptic fit/convulsions in last 6 months or currently on
             treatment for it

         17. History of or currently having malignancy and being treated for it. (exception:
             histologically confirmed and cured carcinoma in situ)

         18. Hypersensitivity reaction to Study drug/placebo

         19. Any psychiatric issue for which the subject is currently undergoing treatment

         20. Any history of drug/alcohol dependence within 30 days of screening or current
             drug/alcohol dependence

         21. Inability to understand the requirements of the Research Protocol and follow the
             research procedures.

         22. Pregnant or lactating;

         23. Not willing to use adequate contraception during study duration

         24. Participation in any other clinical study less than 3months before the start of 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 50 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? Contradiction