Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J101- Influenza due to other identifiedinfluenza virus with other respiratory manifestations
Conditions
Interventions
None listed
Sponsors
Bindi Prashant Shah
Eligibility
Inclusion criteria
Inclusion criteria: Have positive reverse-transcriptase-polymerase chain reaction (RT-PCR) test for COVID-19 in a diagnostic specimen. Are either asymptomatic or have only mild symptoms (cough and/or fever and/or sore throat and/or other upper respiratory symptoms and/or malaise, headache, muscle pain) at the time of study inclusion. Have an oxygen saturation of >94% while breathing ambient air, if this is measured. Have either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) abnormalities in any of these parameters. High blood sugar or HbA1c of any degree will not be a criterion for exclusion. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy [including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner] during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
Exclusion criteria
Exclusion criteria: Have pneumonia confirmed by chest imaging. Patients receiving mechanical ventilation or ECMO or who have multiorgan failure. Pregnant or lactating females. Therapy with an investigational agent within the past 30 days from screening. Treatment with any agent with anti-SARS-CoV-2 activity prior to screening. Any other conditions, including moderate to severe illness, which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of SHIRO KLOMAN in the management of mild to moderate COVID-19 casesTimepoint: Screening,Baseline,3rd Day, 8th day 15th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with negative SARS-CoV-2 on nasal or throat swabTimepoint: Screening, Baseline, 3rd Day 8th day 15th day | — |
Countries
India
Contacts
Public ContactDr Tapan Shah
Sanad Janta Multispeciality Hospital.
Outcome results
None listed